Web-based Self-management Program Research Articles

Assessing the Feasibility and Preliminary Effects of a Web-Based Self-Management Program for Chronic Noncancer Pain: Mixed Methods Study.

In Canada, adults with chronic noncancer pain face a persistent insufficiency of publicly funded resources, with the gold standard multidisciplinary pain treatment facilities unable to meet the high clinical demand. Web-based self-management programs cost-effectively increase access to pain management and can improve several aspects of physical and emotional functioning. Aiming to meet the demand for accessible, fully automated resources for individuals with chronic noncancer pain, we developed a French web- and evidence-based self-management program, Agir pour moi (APM). This program includes pain education and strategies to reduce stress, practice mindfulness, apply pacing, engage in physical activity, identify and manage thinking traps, sleep better, adapt diet, and sustain behavior change. This study aims to assess the APM self-management program's feasibility, acceptability, and preliminary effects in adults awaiting specialized services from a center of expertise in chronic pain management. We conducted a mixed methods study with an explanatory sequential design, including a web-based 1-arm trial and qualitative semistructured interviews. We present the results from both phases through integrative tables called joint displays. Response rates were 70% (44/63) at postintervention and 56% (35/63) at 3-month follow-up among the 63 consenting participants who provided self-assessed information at baseline. In total, 46% (29/63) of the participants completed the program. We interviewed 24% (15/63) of the participants. The interview's first theme revolved around the overall acceptance, user-friendliness, and engaging nature of the program. The second theme emphasized the differentiation between microlevel and macrolevel engagements. The third theme delved into the diverse effects observed, potentially influenced by the macrolevel engagements. Participants highlighted the features that impacted their self-efficacy and the adoption of self-management strategies. We observed indications of improvement in self-efficacy, pain intensity, pain interference, depression, and catastrophizing. Interviewees described these and various other effects as potentially influenced by macrolevel engagement through behavioral change. These findings provided preliminary evidence that the APM self-management program and research methods are feasible. However, some participants expressed the need for at least phone reminders and minimal support from a professional available to answer questions over the first few weeks of the program to engage. Recruitment strategies of a future randomized controlled trial should focus on attracting a broader representation of individuals with chronic pain in terms of gender and ethnicity. ClinicalTrials.gov NCT05319652; https://clinicaltrials.gov/study/NCT05319652.

Developing a Novel Web-Based Self-Management Support Intervention for Polycystic Ovary Syndrome: Mixed Methods Study With Patients and Health Care Professionals.

Polycystic ovary syndrome (PCOS) represents a significant global health burden requiring urgent attention. This common chronic endocrine and cardiometabolic condition affects around 1 in 10 women and individuals assigned female at birth, with significant adverse effects on well-being, quality of life, and mental health, as well as serious and complex long-term health consequences. International guidelines for best health care practice recommend the provision of comprehensive cognitive behavioral interventions to support self-management and improve health outcomes for those living with PCOS. Web-based health interventions have the potential to meet this need in an accessible and scalable way. We aim to identify barriers to self-management and psychological well-being in women with PCOS and adapt a web-based self-management program to provide a prototype digital support intervention for them. We adapted an existing support program (HOPE) for PCOS using the antecedent target measure approach. We conducted qualitative interviews with 13 adult women living with PCOS, 3 trustees of a patients with PCOS advocacy charity, and 4 endocrinologists to identify "antecedents" (barriers) to self-management and psychological well-being. Framework analysis was used to identify potentially modifiable antecedents to be targeted by the novel intervention. At a national conference, 58 key stakeholders (patients and health professionals) voted for the antecedents they felt were most important to address. We used research evidence and relevant theory to design a prototype for the PCOS intervention. Voting identified 32 potentially modifiable antecedents, relating to knowledge, understanding, emotions, motivation, and behaviors, as priorities to be targeted in the new intervention. A modular, web-based prototype HOPE PCOS intervention was developed to address these, covering six broad topic areas (instilling HOPE for PCOS; managing the stress of PCOS; feeding your mind and body well; body image, intimacy, and close relationships; staying healthy with PCOS; and keeping PCOS in its place). We identified barriers to self-management and psychological well-being in women with PCOS and used these to adapt a web-based self-management program, tailoring it for PCOS, which is a comprehensive group intervention combining education, empowerment, lifestyle management, peer support with cognitive behavioral tools, and goal-setting (to be delivered by peers or codelivered with health care professionals). The modular structure offers flexibility to adapt the program further as new clinical recommendations emerge. The intervention has the potential to be delivered, evaluated for feasibility, and, if effective, integrated into health care services. Self-management interventions are not designed to replace clinical care; rather, they serve as an additional source of support. The HOPE PCOS program conveys this message in its content and activities. Future research should evaluate the prototype intervention using primary outcomes such as measures of psychological well-being, self-management self-efficacy, depression, anxiety, and PCOS-related quality of life. They should also assess the intervention's acceptability, scalability, and cost-effectiveness.

Stakeholders' Perspectives, Needs, and Barriers to Self-Management for People With Physical Disabilities Experiencing Chronic Conditions: Focus Group Study.

While self-management programs have had significant improvements for individuals with chronic conditions, less is known about the impact of self-management programs for individuals with physical disabilities who experience chronic conditions, as no holistic self-management programs exist for this population. Similarly, there is limited knowledge of how other stakeholders, such as caregivers, health experts, and researchers, view self-management programs in the context of disability, chronic health conditions, and assistive technologies. This study aimed to obtain insight into how stakeholders perceive self-management relating to physical disability, chronic conditions, and assistive technologies. Nine focus groups were conducted by 2 trained facilitators using semistructured interview guides. Each guide contained questions relating to stakeholders' experiences, challenges with self-management programs, and perceptions of assistive technologies. Focus groups were audio recorded and transcribed. Thematic analysis was conducted on the focus group data. A total of 47 individuals participated in the focus groups. By using a constructivist grounded approach and inductive data collection, three main themes emerged from the focus groups: (1) perspectives, (2) needs, and (3) barriers of stakeholders. Stakeholders emphasized the importance of physical activity, mental health, symptom management, medication management, participant centeredness, and chronic disease and disability education. Participants viewed technology as a beneficial aide to their daily self-management and expressed their desire to have peer-to-peer support in web-based self-management programs. Additional views of technology included the ability to access individualized, educational content and connect with other individuals who experience similar health conditions or struggle with caregiving duties. The findings suggest that the development of any web-based self-management program should include mental health education and resources in addition to physical activity content and symptom management and be cost-effective. Beyond the inclusion of educational resources, stakeholders desired customization or patient centeredness in the program to meet the overall needs of individuals with physical disabilities and caregivers. The development of web-based self-management programs should be holistic in meeting the needs of all stakeholders. ClinicalTrials.gov NCT05481593; https://clinicaltrials.gov/study/NCT05481593.

A Web-Based Cancer Self-Management Program (I-Can Manage) Targeting Treatment Toxicities and Health Behaviors: Human-Centered Co-design Approach and Cognitive Think-Aloud Usability Testing.

Patients with cancer require adequate preparation in self-management of treatment toxicities to reduce morbidity that can be achieved through well-designed digital technologies that are developed in co-design with patients and end users. We undertook a user-centered co-design process in partnership with patients and other knowledge end users to develop and iteratively test an evidence-based and theoretically informed web-based cancer self-management program (I-Can Manage). The specific study aims addressed in 2 phases were to (1) identify from the perspective of patients with cancer and clinicians the desired content, features, and functionalities for an online self-management education and support (SMES) program to enable patient self-management of treatment toxicities (phase 1); (2) develop the SMES prototype based on human-centered, health literate design principles and co-design processes; and (3) evaluate usability of the I-Can Manage prototype through user-centered testing (phase 2). We developed the I-Can Manage program using multiperspective data sources and based on humanistic and co-design principles with end users engaged through 5 phases of development. We recruited adult patients with lung, colorectal, and lymphoma cancer receiving systemic treatments from ambulatory clinics in 2 regional cancer programs for the qualitative inquiry phase. The design of the program was informed by data from qualitative interviews and focus groups, persona and journey mapping, theoretical underpinnings of social cognitive learning theory, and formalized usability testing using a cognitive think-aloud process and user satisfaction survey. A co-design team comprising key stakeholders (human design experts, patients/caregiver, clinicians, knowledge end users, and e-learning and digital design experts) was involved in the developmental process. We used a cognitive think-aloud process to test usability and participants completed the Post-Study System Usability Questionnaire (PSSUQ). In the initial qualitative inquiry phase, 16 patients participated in interviews and 19 clinicians participated in interviews or focus groups and 12 key stakeholders participated in a persona journey mapping workshop to inform development of the program prototype. The I-Can Manage program integrates evidence-based information and strategies for the self-management of treatment toxicities and health-promoting behaviors in 6 e-learning modules (lay termed "chapters"), starting with an orientation to self-management. Behavioral exercises, patient written and video stories, downloadable learning resources, and online completion of goals and action plans were integrated across chapters. Patient participants (n=5) with different cancers, gender, and age worked through the program in the human factors laboratory using a cognitive think-aloud process and all key stakeholders reviewed each chapter of the program and approved revisions. Results of the PSSUQ (mean total score: 3.75) completed following the cognitive think-aloud process (n=5) suggest patient satisfaction with the usability of I-Can Manage. The I-Can Manage program has the potential for activating patients in self-management of cancer and treatment toxicities but requires testing in a larger randomized controlled trial.

Development and Evaluation of a Web-Based Self-Management Program for Korean Adult Patients with Irritable Bowel Syndrome Based on the Information–Motivation–Behavioral Skills Model

This study aimed to develop and assess the effectiveness of a web-based nutrition education program for self-managing IBS symptoms using the IMB model. This study used single-arm, pre–post study design to test the effectiveness of the nutrition education program after its development. Participants were adults in their twenties and thirties in South Korea with IBS according to the ROME IV diagnostic criteria (n = 49). For statistical analysis, normality was verified using the Shapiro–Wilk test, and variables that met the assumption of normality were analyzed using the paired t-test, and variables that did not meet the assumption of normality were analyzed using the Wilcoxon signed-rank test. p < 0.05 was considered statistically significant. IBS patients (n = 49) experienced a statistically significant increase in nutrition knowledge after receiving nutrition education (p = 0.015). IBS patients (n = 35) with no prior experience in nutrition education or diet modification also demonstrated a statistically significant increase in self-efficacy (p = 0.044) and nutrition knowledge (p = 0.016). The web-based nutrition education program based on the IMB model developed in this study was found to be effective. These results will contribute to diversifying symptom prevention strategies for patients with IBS.

My Health, My Life, My Way-An Inclusive Web-Based Self-management Program for People With Disabilities Living With Chronic Conditions: Protocol for a Multiphase Optimization Strategy Study.

Individuals with disabilities living with chronic health conditions require self-management programs that are accessible, sustainable, inclusive, and adaptable. Health coaching is an effective approach to promoting behavior change in self-management. Health coaching combined with telehealth technology has the potential to improve the overall quality of, and access to, health services. This protocol outlines the study design for implementing the My Health, My Life, My Way intervention. The study will assess the feasibility, acceptability, and preliminary efficacy of the intervention for people with disabilities and optimize it. The My Health, My Life, My Way study is a 4-arm randomized controlled trial evaluating the delivery of a 6-month intervention involving telecoaching, inclusive educational content, and technology access for 200 individuals with chronic conditions and physical disabilities. This study uses the engineering-inspired multiphase optimization strategy (MOST) framework to evaluate intervention components and assess whether a combination or lack of individual elements influences behavior. Participants will be randomized to 1 of 4 study arms: scheduled coaching calls and gamified rewards, no scheduled coaching calls and gamified rewards, scheduled coaching calls and flat rewards, and no scheduled coaching calls and flat rewards. The My Health, My Life, My Way study was approved by the institutional review board of the University of Alabama at Birmingham, and recruitment and enrollment will begin in May 2023. Data analysis is expected to be completed within 6 months of ending data collection. This clinical trial protocol was developed based on the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 statement. The My Health, My Life, My Way study will help to optimize and improve our understanding of the feasibility and efficacy of a web-based self-management program for people with physical disabilities and chronic conditions. More specifically, My Health, My Life, My Way will determine which combination of interventions (coaching calls and gamification) will result in increased participation in self-management programming. The My Health, My Life, My Way intervention has the potential to become a scalable and novel method to successfully manage chronic conditions in people with disabilities. ClinicalTrials.gov NCT05481593; https://clinicaltrials.gov/ct2/show/NCT05481593. PRR1-10.2196/31694.

The Influencing Contexts and Potential Mechanisms Behind the Use of Web-Based Self-management Support Interventions: Realistic Evaluation.

BackgroundSelf-management can increase self-efficacy and quality of life and improve disease outcomes. Effective self-management may also help reduce the pressure on health care systems. However, patients need support in dealing with their disease and in developing skills to manage the consequences and changes associated with their condition. Web-based self-management support programs have helped patients with cardiovascular disease (CVD) and rheumatoid arthritis (RA), but program use has been low.ObjectiveThis study aimed to identify the patient, disease, and program characteristics that determine whether patients use web-based self-management support programs or not.MethodsA realistic evaluation methodology was used to provide a comprehensive overview of context (patient and disease characteristics), mechanism (program characteristics), and outcome (program use). Secondary data of adult patients with CVD (n=101) and those with RA (n=77) were included in the study. The relationship between context (sex, age, education, employment status, living situation, self-management [measured using Patient Activation Measure-13], quality of life [measured using RAND 36-item health survey], interaction efficacy [measured using the 5-item perceived efficacy in patient-physician interactions], diagnosis, physical comorbidity, and time since diagnosis) and outcome (program use) was analyzed using logistic regression analyses. The relationship between mechanism (program design, implementation strategies, and behavior change techniques [BCTs]) and outcome was analyzed through a qualitative interview study.ResultsThis study included 68 nonusers and 111 users of web-based self-management support programs, of which 56.4% (101/179) were diagnosed with CVD and 43.6% (78/179) with RA. Younger age and a lower level of education were associated with program use. An interaction effect was found between program use and diagnosis and 4 quality of life subscales (social functioning, physical role limitations, vitality, and bodily pain). Patients with CVD with higher self-management and quality of life scores were less likely to use the program, whereas patients with RA with higher self-management and quality of life scores were more likely to use the program. Interviews with 10 nonusers, 10 low users, and 18 high users were analyzed to provide insight into the relationship between mechanisms and outcome. Program use was encouraged by an easy-to-use, clear, and transparent design and by recommendations from professionals and email reminders. A total of 5 BCTs were identified as potential mechanisms to promote program use: tailored information, self-reporting behavior, delayed feedback, providing information on peer behavior, and modeling.ConclusionsThis realistic evaluation showed that certain patient, disease, and program characteristics (age, education, diagnosis, program design, type of reminder, and BCTs) are associated with the use of web-based self-management support programs. These results represent the first step in improving the tailoring of web-based self-management support programs. Future research on the interaction between patient and program characteristics should be conducted to improve the tailoring of participants to program components.

Our Whole Lives for Hypertension and Cardiac Risk Factors-Combining a Teaching Kitchen Group Visit With a Web-Based Platform: Feasibility Trial.

BackgroundHypertension (HTN) affects millions of Americans. Our Whole Lives: an eHealth toolkit for Hypertension and Cardiac Risk Factors (OWL-H) is an eHealth platform that teaches evidence-based lifestyle strategies, such mindfulness and cooking skills, to improve self-management of HTN.ObjectiveThe primary goal of this pilot study was to evaluate the feasibility of OWL-H combined with teaching kitchen medical group visits (TKMGVs) in a low-income population of participants with HTN.MethodsWe conducted a pre-post 8-week study to assess the feasibility of a hybrid program (a web-based 9-module self-management program, which includes mindfulness and Mediterranean and Dietary Approaches to Stop Hypertension diet) accompanied by 3 in-person TKMGVs among patients with HTN. Data including demographics, platform use, and satisfaction after using OWL-H were examined. Outcome data collected at baseline and 8 weeks included the Mediterranean Diet Questionnaire, Hypertension Self-Care Profile Self-Efficacy Instrument, Blood Pressure Knowledge Questionnaire, and the number of self-reported blood pressure readings. For the statistical analysis, we used descriptive statistics, paired sample t tests (1-tailed), and qualitative methods.ResultsOf the 25 enrolled participants, 22 (88%) participants completed the study. Participants’ average age was 57 (SD 12.1) years, and 46% (11/24) of them reported a household income <US $30,000 per year. Among the 22 participants who logged in to OWL-H, the average number of mindfulness practices completed was 7 and the average number of module sessions accessed was 4. In all, 73% (16/22) of participants reported that they were “very satisfied” with using OWL-H to help manage their HTN. Participants’ blood pressure knowledge significantly increased from baseline (mean 5.58, SD 1.44) to follow-up (mean 6.13, SD 1.23; P=.03). Participants significantly increased their adherence to a Mediterranean diet from baseline (mean 7.65, SD 2.19) to follow-up (mean 9, SD 1.68; P=.004). Participants’ self-efficacy in applying heart-healthy habits, as measured by the Hypertension Self-Care Profile Self-Efficacy Instrument, increased from baseline (mean 63.67, SD 9.06) to follow-up (mean 65.54, SD 7.56; P=.14). At the 8-week follow-up, 82% (18/22) of the participants had self-reported their blood pressure on the OWL-H platform at least once during the 8 weeks.ConclusionsThe eHealth platform for HTN self-management, OWL-H, and accompanying in-person TKMGVs have the potential to effectively improve lifestyle management of HTN.Trial RegistrationClinicalTrials.gov NCT03974334; https://clinicaltrials.gov/ct2/show/NCT03974334

Feasibility, Acceptability, and Clinical Significance of a Dyadic, Web-Based, Psychosocial and Physical Activity Self-Management Program (TEMPO) Tailored to the Needs of Men with Prostate Cancer and Their Caregivers: A Multi-Center Randomized Pilot Trial.

Background: Prostate cancer is the most common cancer diagnosis among men. Family caregivers (often female spouses) play a key role in ensuring patients’ needs are met, frequently assuming their role with no formal training, which can contribute to a high burden. The purpose of this study was to pilot TEMPO—the first dyadic, Tailored, wEb-based, psychosocial and physical activity self-Management PrOgram for men with prostate cancer and their caregivers. Methods: 49 men with prostate cancer and their caregivers were randomized to TEMPO or usual care. Baseline and follow-up questionnaires were completed to assess feasibility, acceptability, and clinical significance. A priori benchmarks for these outcomes were set. Thirteen exit interviews were conducted to further explore acceptability. Results: Feasibility benchmarks were met with the exception for recruitment with on average 6.1 dyads recruited/month (benchmark: 8 dyads/month). Benchmarks of acceptability focused on attrition (<25%) and system usability, which were met. Using the strict criteria for adherence of 100% of the module viewed and participants spending at least 15 min on the module, 45% of participants were adherent. The clinical significance on anxiety and quality of life was supported for caregivers, and mostly supported for the men with prostate cancer. Conclusion: This pilot trial was successful, with minor modifications needed prior to a large trial.

Getting "Back on Track" After a Cardiac Event: Protocol for a Randomized Controlled Trial of a Web-Based Self-management Program.

BackgroundAfter a cardiac event, a large majority of patients with cardiac conditions do not achieve recommended behavior change targets for secondary prevention. Mental health issues can also impact the ability to engage in health behavior change. There is a need for innovative, flexible, and theory-driven eHealth programs, which include evidence-based strategies to assist patients with cardiac conditions with their recovery, especially in behavioral and emotional self-management.ObjectiveThe aim of this study is to determine the short- and longer-term behavioral and emotional well-being outcomes of the Back on Track web-based self-management program. In addition, this study will test whether there is enhanced benefit of providing one-on-one telephone support from a trained lifestyle counselor, over and above benefit obtained through completing the web-based program alone.MethodsPeople who have experienced a cardiac event in the previous 12 months and have access to the internet will be eligible for this study (N=120). Participants will be randomly assigned to one of the two study conditions: either “self-directed” completion of the Back on Track program (without assistance) or “supported” completion of the Back on Track program (additional 2 telephone sessions with a lifestyle counselor). All participants will have access to the web-based Back on Track program for 2 months. Telephone sessions with the supported arm participants will occur at approximately 2 and 6 weeks post enrollment. Measures will be assessed at baseline, and then 2 and 6 months later. Outcome measures assessed at all 3 timepoints include dietary intake, physical activity and sitting time, smoking status, anxiety and depression, stage of change, and self-efficacy in relation to behavioral and emotional self-management, quality of life, and self-rated health and well-being. A demographic questionnaire will be included at baseline only and program acceptability at 2 months only.ResultsRecruitment began in May 2020 and concluded in August 2021. Data collection for the 6-month follow-up will be completed by February 2022, and data analysis and publication of results will be completed by June 2022. A total of 122 participants were enrolled in this study.ConclusionsThe Back on Track trial will enable us to quantify the behavioral and emotional improvements obtained and maintained for patients with cardiac conditions and, in particular, to compare two modes of delivery: (1) fully self-directed delivery and (2) supported by a lifestyle counselor. We anticipate that the web-based Back on Track program will assist patients in their recovery and self-management after an acute event, and represents an effective, flexible, and easily accessible adjunct to center-based rehabilitation programs.Trial RegistrationAustralian New Zealand Clinical Trials Registry ACTRN12620000102976; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378920&isReview=trueInternational Registered Report Identifier (IRRID)DERR1-10.2196/34534

A randomized controlled trial of self-management for people with epilepsy and a history of negative health events (SMART) targeting rural and underserved people with epilepsy: a methodologic report

BackgroundMany people living with epilepsy (PLWE) reside in rural communities, and epilepsy self-management may help address some of the gaps in epilepsy care for these communities. A prior randomized control trial of a remotely delivered, Web-based group format 12-week self-management program (SMART) conducted in Northeast Ohio, a primarily urban and suburban community, demonstrated improved outcomes in negative health events such as depression symptoms and quality of life. However, there is a paucity of research addressing the needs of PLWE in rural settings.MethodsThe present study leverages collaboration between investigators from 2 mid-western US states (Ohio and Iowa) to replicate testing of the SMART intervention and prioritize delivery to PLWE in rural and semi-rural communities. In phase 1, investigators will refine the SMART program using input from community stakeholders. A Community Advisory Board will then be convened to help identify barriers to trial implementation and strategies to overcome barriers. In phase 2, the investigators will conduct a 6-month prospective randomized control trial of the SMART program compared to 6-month waitlist controls, with the primary outcome being changes in negative health events defined as seizure, self-harm attempt, emergency department visit, or hospitalization. Additional outcomes of interest include quality of life and physical and mental health functioning. The study will also assess process measures of program adopters and system end-users to inform future outreach, education, and self-management strategies for PLWE.DiscussionThe method of this study employs lived experience of PLWE and those who provide care for PLWE in rural and underserved populations to refine a remotely delivered Web-based self-management program, to improve recruitment and retention, and to deliver the intervention. Pragmatic outcomes important to PLWE, payers, and policymakers will be assessed. This study will provide valuable insights on implementing future successful self-management programs.Trial registrationClinicalTrials.gov NCT04705441. Registered on January 12, 2021

Mobile web-based self-management program for breast cancer patients with chemotherapy-induced amenorrhoea: A quasi-experimental study.

AimThe aim of this study was to examine the effects of a mobile web‐based self‐management program on menopausal symptoms, self‐efficacy and quality of life in breast cancer patients with chemotherapy‐induced amenorrhoea.DesignA quasi‐experimental pretest–posttest design with repeated measures.MethodsThe study was carried out at a university medical centre between October 2017 and September 2018. The intervention group received a 12‐week mobile web‐based self‐management program including education and coaching/support. Multiple instruments were used to measure menopausal symptoms, self‐efficacy, and quality of life at pre‐test, after the intervention (post‐test), and 3 months post‐intervention (follow‐up test). Repeated measure ANOVA was used to analyse the data.ResultsIn the intervention group, menopausal symptoms were significantly improved compared to the control group at the follow‐up test. In the follow‐up test, the intervention group's self‐efficacy and quality of life were significantly improved, whereas that of the control group was decreased.

A web-based self-management program to improve lifestyle and blood pressure control in patients with primary hypertension: a randomized controlled trial

Abstract Background Hypertension contributes to the main risk factor of the high incidence of cardiovascular diseases and mortality. Successful control of blood pressure requires behavioral changes; therefore, it is of considerable importance to develop a web-based self-management program that assist patients to tailor their lifestyle and empower them manage their disease. Objective Our primary aims were to evaluate the effects of a web-based self-management program for improving blood pressure and blood lipids control in patients with primary hypertension. Our secondary aims were to evaluate the effects of the web-based self-management program on enhancing patients' lifestyle, medication adherence and self-efficacy. Methods This randomized controlled trial used permuted block randomization design and randomly divided the 222 patients into the intervention group (n=111) and control group (n=111). Patients in the intervention group received the web-based self-management program, and the control group received standard care. Lifestyle and medication adherence were assessed by using the Hypertension Self-Care Activity Level Effects Scale (H-SCALE). Self-efficacy was measured through using the Chinese version of the Self-Efficacy for Managing Chronic Disease 6-Item Scale (SES6C). The data of blood pressure and serum lipids were collected through web-based self-report and chart review. We used the generalized estimating equations to evaluate the effects of the intervention. Results There were no statistically significant differences of the baseline demographic characteristics and antihypertensive dosages from both groups. The intervention group received the web-based self-management program and showed a decrease in systolic blood pressures (−19.82 mmHg vs 7.99 mmHg, p&amp;lt;0.001) and diastolic blood pressures at 6 months (−9.17 mmHg vs 0.48 mmHg, p&amp;lt;0.001) compared to the control group. Regarding the H-SCALE scores measured at 6 months, the intervention group achieved a higher Medication Adherence Subscale scores (p&amp;lt;0.001), Diet Subscale scores (p&amp;lt;0.001), and Weight Management Subscale scores (p&amp;lt;0.001) than those of the control group. The intervention group achieved a higher SES6C scores than that of the control group (p&amp;lt;0.001) at 6 months. Finally, the intervention group had significantly lower serum levels of triglycerides and low-density lipoproteins than the control group at 6 months (−11.38 mg/dL vs 16.31 mg/dL, −9.93 mg/dL vs 3.12 mg/dL, respectively, p&amp;lt;0.001). Conclusion The greatest benefit of this program was allowing participants to consult dietary issues with us immediately. Since lifestyles vary among different individuals, we considered the individuality of each participant when providing feedback and involving them in the devising of interventions to increase their confidence in hypertension self-care and ultimately achieve the optimal control of blood pressure and blood lipid levels. Funding Acknowledgement Type of funding sources: None.

Telehealth Behavioral Intervention for Diabetes Management in Adults With Physical Disabilities: Intervention Fidelity Protocol for a Randomized Controlled Trial

BackgroundDiabetes mellitus is a major health problem among people with physical disabilities. Health coaching has been proven to be an effective approach in terms of behavioral changes, patient self-efficacy, adherence to treatment, health service use, and health outcomes. Telehealth systems combined with health coaching have the potential to improve the quality of health care by increasing access to services. Treatment fidelity is particularly important for behavior change studies; however, fidelity protocols are inadequately administered and reported in the literature.ObjectiveThe aim of this study is to outline all the intervention fidelity strategies and procedures of a telecoaching intervention—artificial intelligence for diabetes management (AI4DM)—which is a randomized controlled trial to evaluate the feasibility, acceptability, and preliminary efficacy of a telehealth platform in adults with type 2 diabetes and permanent impaired mobility. AI4DM aims to create a web-based disability-inclusive diabetes self-management program. We selected the National Institutes of Health Behavior Change Consortium (NIH BCC) fidelity framework to describe strategies to ensure intervention fidelity in our research.MethodsWe have developed fidelity strategies based on the five fidelity domains outlined by the NIH BCC—focusing on study design, provider training, treatment delivery, treatment receipt, and enactment of treatment skills. The design of the study is grounded in the social cognitive theory and is intended to ensure that both arms would receive the same amount of attention from the intervention. All providers will receive standardized training to deliver consistent health coaching to the participants. The intervention will be delivered through various controlling and monitoring strategies to reduce differences within and between treatment groups. The content and structure of the study are delivered to ensure comprehension and participation among individuals with low health literacy. By constantly reviewing and monitoring participant progress and protocol adherence, we intend to ensure that participants use cognitive and behavioral skills in real-world settings to engage in health behavior.ResultsEnrollment for AI4DM will begin in October 2021 and end in October 2022. The results of this study will be reported in late 2022.ConclusionsDeveloping and using fidelity protocols in behavior change studies is essential to ensure the internal and external validity of interventions. This study incorporates NIH BCC recommendations into an artificial intelligence embedded telecoaching platform for diabetes management designed for people with physical disabilities. The developed fidelity protocol can provide guidance for other researchers conducting telehealth interventions within behavioral health settings to present more consistent and reproducible research.Trial RegistrationClinicalTrials.gov NCT04927377; http://clinicaltrials.gov/ct2/show/NCT04927377.International Registered Report Identifier (IRRID)PRR1-10.2196/31695

Disability-Inclusive Diabetes Self-management Telehealth Program: Protocol for a Pilot and Feasibility Study.

BackgroundIndividuals with disabilities and type 2 diabetes require self-management programs that are accessible, sustainable, inclusive, and adaptable. Health coaching has been shown to be an effective approach for improving behavioral changes in self-management. Health coaching combined with telehealth technology has the potential to improve the overall quality of and access to health services.ObjectiveThis protocol outlines the study design for implementing the Artificial Intelligence for Diabetes Management (AI4DM) intervention. The protocol will assess the feasibility, acceptability, and preliminary efficacy of the AI4DM telehealth platform for people with disabilities.MethodsThe AI4DM study is a 2-arm randomized controlled trial for evaluating the delivery of a 12-month intervention, which will involve telecoaching, diabetes educational content, and technology access, to 90 individuals with diabetes and physical disabilities. The hypothesis is that this pilot project is feasible and acceptable for adults with permanently impaired mobility and type 2 diabetes. We also hypothesize that adults in the AI4DM intervention groups will have significantly better glycemic control (glycated hemoglobin) and psychosocial and psychological measures than the attention control group at the 3-, 6-, and 12-month follow-ups.ResultsThe AI4DM study was approved by the university’s institutional review board, and recruitment and enrollment will begin in October 2021.ConclusionsThe AI4DM study will improve our understanding of the feasibility and efficacy of a web-based diabetes self-management program for people with disabilities. The AI4DM intervention has the potential to become a scalable and novel method for successfully managing type 2 diabetes in people with disabilities.Trial RegistrationClinicalTrials.gov NCT04927377; https://clinicaltrials.gov/ct2/show/NCT04927377International Registered Report Identifier (IRRID)PRR1-10.2196/31689

Web-Based Self-management Program (SPACE for COPD) for Individuals Hospitalized With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease: Nonrandomized Feasibility Trial of Acceptability.

BackgroundHospital admissions due to the acute exacerbation of chronic obstructive pulmonary disease (AECOPD) are costly for individuals and health services. Pulmonary rehabilitation (PR) is known to reduce hospital readmissions when delivered after hospitalization, but the uptake and completion of PR following hospitalization remains poor (<10% of those eligible in the UK audit data). A web-based platform of the SPACE (Self-management Program of Activity Coping and Education) for COPD (chronic obstructive pulmonary disease) has previously shown promising results in patients with stable COPD but has not been tested following an AECOPD.ObjectiveThis study aims to assess the feasibility and acceptability of a web-based self-management program.MethodsA nonrandomized feasibility study for patients with confirmed AECOPD who were deemed web literate was conducted. All patients consented during their hospitalization and received access to the website following discharge in addition to usual care. The program aims to facilitate patients to better understand and manage their condition through education and home-based exercises. Participants were asked to complete the Bristol COPD Knowledge Questionnaire at baseline and after 6 months. A total of 14 participants were also interviewed (n=8 completers; n=6 noncompleters) regarding their experiences with the web-based program and trial. The interviews were analyzed using thematic analysis.ResultsIn total, 2080 patients were screened for eligibility, of which 100 patients (age: mean 71.2 years, SD 9.3 years; male: 55/100, 55%; forced expiratory volume in 1 second/forced vital capacity ratio: mean 0.46, SD 0.14; pack-years: mean 50.2, SD 31.0; current smokers: 35/100, 35%) were recruited (4.8% of those screened). The main reason for ineligibility was a lack of web literacy (1366/1980, 68.98%). In total, 18% (18/100) of patients had completed the web program by 6 months, with others still registered in the program (27/100, 27%), and more than half did not register (55/100, 55%). There was a mean change in Bristol COPD Knowledge Questionnaire scores at 6 months of 7.8 (SD 10.2) points. Qualitative interviews identified three main themes: preparing for, engagement with, and benefits of the study and program. A total of 57% (57/100) accepted a referral to PR on discharge and 19% (19/100) had completed the program after 6 months.ConclusionsOn the basis of the challenges of recruiting, retaining, and engaging participants in a web-based self-management program, it is not a feasible approach to roll out widely. This study acknowledges that this is a challenging time for patients with an AECOPD to engage in exercise and self-management education. However, for patients who were able to engage in such an intervention, the completion rate of PR was double the previous audit estimates from the United Kingdom, disease knowledge improved, and the intervention was of value to patients.Trial RegistrationISRCTN Registry 13081008; https://www.isrctn.com/ISRCTN13081008

A study protocol for a multicenter randomized pilot trial of a dyadic, tailored, web-based, psychosocial, and physical activity self-management program (TEMPO) for men with prostate cancer and their caregivers

BackgroundProstate cancer predisposes patients and caregivers to a wide range of complex physical and psychosocial challenges, and interventions must incorporate a wide range of self-management strategies to help patients and their caregivers effectively cope with cancer challenges. To palliate this need, our team recently developed and evaluated the initial acceptability of a dyadic, Tailored, wEb-based, psychosocial, and physical activity self-Management PrOgram (TEMPO). TEMPO is a 10-week, interactive, web-based intervention consisting of five modules designed to help dyads manage their physical and psychosocial needs. It aims to teach dyads new self-management strategies and encourages them to increase their physical activity (PA) levels, mainly through walking and strength-based exercises. Initial acceptability evaluation of TEMPO revealed high user satisfaction, in addition to having a number of potential benefits for participants. After integrating suggested changes to TEMPO, the proposed pilot study aims to further test the acceptability and feasibility of TEMPO.MethodsThis study is a multicenter, stratified, parallel, two-group, pilot randomized control trial (RCT), where patient–caregiver dyads are randomized (stratified by anxiety level) to receive (a) TEMPO or (b) usual care. Participants (n goal = 40) are recruited across Canada at participating cancer centers and through self-referral (e.g., online recruitment). Patient inclusion criteria are (a) having received prostate cancer treatment within the past 2 years or scheduled to receive treatment, (b) identified a primary caregiver willing to participate in the study, and (c) has access to the Internet. Eligible caregivers are those identified by the patient as his primary source of support. Dyads complete a baseline questionnaire (T1) and another one 3 months later (T2) assessing various aspects of physical and emotional functioning (e.g., the Medical Outcomes Study (MOS) 12-item Short Form Health Survey (SF-12), the Hospital Anxiety and Depression Scale (HADS), and the Perceived Stress Scale (PSS)), self-management behaviors (e.g., the Health Education Impact Questionnaire (heiQ)), physical activity (the International Physical Activity Questionnaires (IPAQ) and the Multidimensional Self-efficacy for Exercise Scale (MSES)), and dyadic coping (the Dyadic Coping Inventory (DCI)). Dyads that used TEMPO are also asked to participate in a semi-structured exit interview exploring their overall experience with the program.DiscussionThis feasibility analysis will begin to develop the knowledge base on TEMPO’s value for men with prostate cancer and their caregivers to inform a larger trial.Trial registrationNCT04304196

Acceptability and Usefulness of a Dyadic, Tailored, Web-Based, Psychosocial and Physical Activity Self-Management Program (TEMPO): A Qualitative Study

Caregivers of men with prostate cancer report high burden, and there is a need to develop cost-effective programs to support them in their roles. This study reports on the acceptability of a dyadic, Tailored, wEb-based, psychosocial and physical activity (PA) self-Management PrOgram called TEMPO. TEMPO was accessed by a convenience sample of 19 men with prostate cancer and their caregivers (n = 18), as well as six health care professionals (HCPs). User feedback was gathered via semi-structured qualitative interviews. Data were analyzed using thematic analysis. Most dyads were satisfied with TEMPO, particularly with the dyadic feature of TEMPO, the focus on goal setting to integrate self-management, and the extensive health library. The patients and caregivers motivated each other as they worked through TEMPO. Most goals to achieve during TEMPO pertained to increasing PA, followed by learning physical symptom management. One unanticipated benefit of TEMPO for the dyads was improved communication. HCPs agreed that TEMPO was a novel approach to online cancer self-management and they echoed the benefits reported by dyads. Key suggestions for improving TEMPO were to reduce repetition, tailor content, add more exercise ideas, and have more printing options. This study provides a strong foundation on which to plan a larger trial.

Prostate Cancer Survivors' and Caregivers' Experiences Using Behavior Change Techniques during a Web-Based Self-Management and Physical Activity Program: A Qualitative Study.

Both men with prostate cancer and their caregivers report experiencing a number of challenges and health consequences, and require programs to help support the cancer patient–caregiver dyad. A tailored, web-based, psychosocial and physical activity self-management program (TEMPO), which implements behavior change techniques to help facilitate behavior change for the dyads was created and its acceptability was tested in a qualitative study. The purpose of this secondary analysis was to explore the dyads’ experiences using behavior change techniques to change behavior and address current needs and challenges while enrolled in TEMPO. Multiple semi-structured interviews were conducted with 19 prostate cancer-caregiver dyads over the course of the program, resulting in 46 transcripts that were analyzed using an inductive thematic analysis. Results revealed four main themes: (1) learning new behavior change techniques, (2) engaging with behavior change techniques learned in the past, (3) resisting full engagement with behavior change techniques, and (4) experiencing positive outcomes from using behavior change techniques. The dyads’ discussions of encountering behavior change techniques provided unique insight into the process of learning and implementing behavior change techniques through a web-based self-management program, and the positive outcomes that resulted from behavior changes.

Effectiveness of a Web-Based SUpport PRogram (SUPR) for Hearing Aid Users Aged 50+: Two-Arm, Cluster Randomized Controlled Trial.

BackgroundHearing aid (HA) use is known to improve health outcomes for people with hearing loss. Despite that, HA use is suboptimal, and communication issues and hearing-related activity limitations and participation restrictions often remain. Web-based self-management communication programs may support people with hearing loss to effectively self-manage the impact of hearing loss in their daily lives.ObjectiveThe goal of the research is to examine the short- and long-term effects of a web-based self-management SUpport PRogram (SUPR) on communication strategy use (primary outcome) and a range of secondary outcomes for HA users aged 50 years and older.MethodsClients of 36 HA dispensing practices were randomized to SUPR (SUPR recipients; n=180 HA users) and 34 to care as usual (controls; n=163 HA users). SUPR recipients received a practical support booklet and online materials delivered via email over the course of their 6-month HA rehabilitation trajectory. They were encouraged to appoint a communication partner and were offered optional email contact with the HA dispensing practice. The online materials included 3 instruction videos on HA handling, 5 videos on communication strategies, and 3 testimonial videos. Care as usual included a HA fitting rehabilitation trajectory only. Measurements were carried out at baseline, immediately postintervention, 6 months postintervention, and 12 months postintervention. The primary outcome measure was self-reported use of communication strategies (3 subscales of the Communication Profile for the Hearing Impaired [CPHI]). Secondary outcome measures included self-reported personal adjustment to hearing loss (CPHI); use, satisfaction and benefit of HAs and SUPR (use questionnaire; International Outcome Inventory for Hearing Aids [IOI-HA], Alternative Interventions [IOI-AI]); recommendation of HA dispensing services; self-efficacy for HA handling (Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids [MARS-HA]); readiness to act on hearing loss (University of Rhode Island Change Assessment adapted for hearing loss [URICA-HL]); and hearing disability (Amsterdam Inventory for Auditory Disability and Handicap [AIADH]).ResultsLinear mixed model analyses (intention to treat) showed no significant differences between the SUPR and control group in the course of communication strategy use (CPHI). Immediately postintervention, SUPR recipients showed significantly higher self-efficacy for advanced HA handling than the controls, which was sustained at 12 months (MARS-HA; mean difference immediately postintervention: 5.3, 95% CI 0.3 to 10.4; P=.04). Also, SUPR recipients showed significantly greater HA satisfaction than controls immediately postintervention (IOI-HA; 0.3, 95% CI 0.09 to 0.5; P=.006), which was sustained at 12 months, and significantly greater HA use than the controls immediately postintervention (IOI-HA; 0.3, 95% CI 0.02 to 0.5; P=.03), which was not sustained at 12 months.ConclusionsThis study provides ground to recommend adding SUPR to standard HA dispensing care, as long-term, modest improvements in HA outcomes were observed. Further research is needed to evaluate what adjustments to SUPR are needed to establish long-term effectiveness on outcomes in the psychosocial domain.Trial RegistrationISRCTN77340339; http://www.isrctn.com/ISRCTN77340339International Registered Report Identifier (IRRID)RR2-10.1136/bmjopen-2016-015012