Digital Self-management Intervention Research Articles

Digital Health and Self-Management in Idiopathic Inflammatory Myopathies: A Missed Opportunity?

This paper explored the potential of digital health in idiopathic inflammatory myopathies (IIMs), with a focus on self-management. Digital self-management technology includes tailored treatment plans, symptom tracking, educational resources, enhanced communication, and support for long-term planning. After arguing the importance of digital health in IIMs management, from diagnosis until treatment, our literature review revealed a notable gap in research focusing on the efficacy of digital self-management interventions for individuals with IIMs, with no randomised controlled trials or observational studies addressing this topic. Our review further highlighted the significant unmet need for research in self-management interventions for individuals with IIMs. The absence of studies underscores the necessity for collaborative efforts to address this gap and develop personalised, effective strategies for managing IIMs using digital technology. Individuals with IIMs deserve tailored self-management approaches akin to those available for other rheumatic and musculoskeletal diseases.

12424 A Feasibility Trial Of A Co-created Digital Self-management Programme For Adults With Polycystic Ovary Syndrome (Hope PCOS)

Abstract Disclosure: C.A. Percy: None. A. Turner: None. L. Aphramor: None. D. Broom: None. C. Clark: None. F. Martin: None. P. Wark: None. Introduction: Polycystic ovary syndrome (PCOS) has significant impact on depression, anxiety, psychological wellbeing and health-related quality of life. We co-created a theory-led, evidence-based, 6-week, digital self-management and positive wellbeing intervention (Hope PCOS), delivered to UK adults. We tested the intervention’s potential to improve mental health and wellbeing outcomes and its acceptability and usability for adults living with PCOS. Methods: This was a mixed methods feasibility randomised controlled trial conducted online, with a pre-post, waitlist-controlled design. Primary outcomes were recruitment, completion (≥ 3 intervention sessions) and follow-up rates. At baseline, participants reported demographic information, PCOS symptoms, depression (Patient Health Questionnaire (PHQ-9)), anxiety ((Generalised Anxiety Disorder Assessment (GAD-7)), polycystic ovary syndrome health-related quality of life (PCOSQ-50), psychological wellbeing (Warwick-Edinburgh Mental Wellbeing Scale, WEMWBS) and self-efficacy (Self-Efficacy to Manage Chronic Disease Scale (SEMCD6)) before randomisation to an intervention group (IG) receiving the intervention immediately or a waitlist control group (CG) receiving the intervention 12 weeks later. PHQ-9, GAD-7, PCOSQ-50, WEMWBS and SEMDC6 were reassessed at 6 and 12 weeks. IG participants reported the usability of the digital intervention (system usability scale (SUS)) and acceptability via qualitative exit interviews. Results: Of 131 eligible, consented participants, 83% (N=109, age M=37.1, SD=8.6 years) completed baseline measures and were randomised to the IG (n=54) or the CG (n=55). Baseline clinical caseness was high for depression (n=77, 70.6%) and anxiety (n=78, 71.6 %). Twenty-one participants (39%) in the IG completed ≥3 intervention sessions. At 6-week follow-up, completion of secondary outcomes was n=32 (59%) for IG and n= 38 (69%) for CG; at 12 weeks, n=31 (57%) for IG and n= 38 (69%) for CG. Twelve IG participants took part in the exit interviews. Exploratory descriptive statistics suggest there were greater improvements in depression, anxiety, psychological wellbeing, self-efficacy and quality of life for the intervention group completers compared to the waitlist control group. SUS data and thematic analysis suggest the intervention was usable, acceptable, relevant and interesting. Participants reported experiences including feeling seen and valued, having the difficulties of lifestyle change acknowledged, and learning valuable lessons, particularly how to monitor and manage emotions, prioritise self-care and complete personal goals. Conclusions: This novel intervention was rated as usable and acceptable, with potential for improving mental health and wellbeing outcomes. More research is needed to identify for whom the intervention is beneficial and on implementation in practice. Presentation: 6/1/2024

Living well with chronic pain: a 12-month randomized controlled trial revealing impact from the digital pain self-management program EPIO.

Chronic pain affects a wide range of physical and psychological aspects of life for those impacted. Psychosocial treatment approaches may be of support, but outreach is still limited. To evaluate the efficacy of EPIO, an evidence-informed, user-centered digital self-management intervention for people with chronic pain, in a 12-month randomized controlled trial. People living with chronic pain (N = 266) were randomized to the EPIO intervention (n = 132) or a usual-care control group (n = 134). The intervention was delivered in a simple blended care model, and outcome measures collected at baseline, 6 months, and 12 months. Generalized linear models for repeated measures were fitted to compare groups over time. Participants were primarily female (81%), median age 49 years (range 22-78), with heterogeneous pain conditions, and had lived with pain >5 years (77.6%). A mixed linear model with all timepoints included revealed no statistically significant group differences for the primary outcome of pain interference. Significant psychological benefits in favor of the intervention group were however detected for depression (P = 0.022), self-regulatory fatigue (P = 0.024), vitality (P = 0.016), and mental health (P = 0.047). Baseline to 12-month changes showed additional favorable effects for anxiety (between-group mean differences [MDs] = 0.79, P = 0.047), depression (MD = 1.08, P = 0.004), self-regulatory fatigue (MD = 2.42, P = 0.021), pain catastrophizing (MD = 2.62, P = 0.009), and health-related quality of life. The EPIO program aims to improve outreach of evidence-based pain self-management interventions. Findings demonstrate how using EPIO can lead to sustainable psychological change, enhancing mental health and health-related quality of life for people suffering from pain, providing a chance to live well with the pain.

Service Users' Experiences of a Nationwide Digital Type 2 Diabetes Self-Management Intervention (Healthy Living): Qualitative Interview Study.

Diabetes Self-Management Education and Support programs for people living with type 2 diabetes mellitus (T2DM) can increase glycemic control and reduce the risk of developing T2DM-related complications. However, the recorded uptake of these programs is low. Digital self-management interventions have the potential to overcome barriers associated with attendance at face-to-face sessions. Healthy Living is an evidence-based digital self-management intervention for people living with T2DM, based on the Healthy Living for People with Type 2 Diabetes (HeLP-Diabetes) intervention, which demonstrated effectiveness in a randomized controlled trial. NHS England has commissioned Healthy Living for national rollout into routine care. Healthy Living consists of web-based structured education and Tools components to help service users self-manage their condition, including setting goals. However, key changes were implemented during the national rollout that contrasted with the trial, including a lack of facilitated access from a health care professional and the omission of a moderated online support forum. This qualitative study aims to explore service users' experiences of using Healthy Living early in the national rollout. A total of 19 participants were interviewed via telephone or a videoconferencing platform. Topics included users' experiences and views of website components, their understanding of the intervention content, and the overall acceptability of Healthy Living. Transcripts were analyzed thematically using a framework approach. Participants valued having trustworthy information that was easily accessible. The emotional management content resonated with the participants, prompting some to book an appointment with their general practitioners to discuss low mood. After completing the structured education, participants might have been encouraged to continue using the website if there was more interactivity (1) between the website and other resources and devices they were using for self-management, (2) with health professionals and services, and (3) with other people living with T2DM. There was consensus that the website was particularly useful for people who had been newly diagnosed with T2DM. Digital Diabetes Self-Management Education and Support programs offering emotional aspects of self-management are addressing an unmet need. Primary care practices could consider offering Healthy Living to people as soon as they are diagnosed with T2DM. Participants suggested ways in which Healthy Living could increase interaction with the website to promote continued long-term use.

Acceptability, Effectiveness, and Roles of mHealth Applications in Supporting Cancer Pain Self-Management: Integrative Review.

Cancer pain remains highly prevalent and persistent throughout survivorship, and it is crucial to investigate the potential of leveraging the advanced features of mobile health (mHealth) apps to empower individuals to self-manage their pain. This review aims to comprehensively understand the acceptability, users' experiences, and effectiveness of mHealth apps in supporting cancer pain self-management. We conducted an integrative review following Souza and Whittemore and Knafl's 6 review processes. Literature was searched in PubMed, Scopus, CINAHL Plus with Full Text, PsycINFO, and Embase, from 2013 to 2023. Keywords including "cancer patients," "pain," "self-management," "mHealth applications," and relevant synonyms were used in the search. The Johns Hopkins research evidence appraisal tool was used to evaluate the quality of eligible studies. A narrative synthesis was conducted to analyze the extracted data. A total of 20 studies were included, with the overall quality rated as high (n=15) to good (n=5). Using mHealth apps to monitor and manage pain was acceptable for most patients with cancer. The internal consistency of the mHealth in measuring pain was 0.96. The reported daily assessment or engagement rate ranged from 61.9% to 76.8%. All mHealth apps were designed for multimodal interventions. Participants generally had positive experiences using pain apps, rating them as enjoyable and user-friendly. In addition, 6 studies reported significant improvements in health outcomes, including enhancement in pain remission (severity and intensity), medication adherence, and a reduced frequency of breakthrough pain. The most frequently highlighted roles of mHealth apps included pain monitoring, tracking, reminders, education facilitation, and support coordination. mHealth apps are effective and acceptable in supporting pain self-management. They offer a promising multi-model approach for patients to monitor, track, and manage their pain. These findings provide evidence-based insights for leveraging mHealth apps to support cancer pain self-management. More high-quality studies are needed to examine the effectiveness of digital technology-based interventions for cancer pain self-management and to identify the facilitators and barriers to their implementation in real-world practice.

The effectiveness of digital interventions for self-management of chronic pain in employment settings: a systematic review.

Chronic pain affects over a quarter of the workforce with high economic burden for individuals, employers and healthcare services. Access to work-related advice for people with chronic pain is variable. This systematic review aims to explore the effectiveness of workplace-delivered digital interventions for the self-management of chronic pain. MEDLINE, EMBASE, CINAHL, PsycINFO, the Cochrane Library, JBI, Open Science Framework, Epistemonikos and Google Scholar. Articles published between January 2001 and December 2023 were included. Searches were conducted between October 2023 and December 2023. Workplace-delivered digital interventions to support self-management of chronic pain at work may improve pain and health-related quality of life in vocationally active adults. Delivering interventions outside of clinical services, through the workplace setting, may help to reduce inequity in access to work-related advice for people with chronic pain, and ultimately reduce the burden on individuals, employers and healthcare services. Interventions include mobile apps and web-based programmes. Studies were moderate-to-low quality. Most studies focused on exercise, few considered other aspects of pain self-management. Given the limited evidence in the current literature, consensus on best intervention format and delivery is lacking. More high-quality studies are needed given the heterogeneity in study design, interventions and outcome measures. No interventions included advice on work-related adjustments or support. Few studies included work-related outcomes, despite the known impact of pain on work and work on health.

Participation in a digital self-management intervention for osteoarthritis and socioeconomic inequalities in patient-related outcomes

Objective To investigate changes in socioeconomic inequalities in patient-related outcomes and pain medication use, following participation in a digital self-management intervention for osteoarthritis (OA) in Sweden. Method Participants with hip/knee OA enrolled in the digital intervention were included. Self-reported outcomes collected were the numerical rating scale (NRS) pain, activity impairment, general health, Knee/Hip injury and Osteoarthritis Outcome Score (KOOS-12, HOOS-12) Pain, Function, and Quality of Life subscales, 5-level EuroQol 5 Dimensions (EQ-5D-5L), Patient Acceptable Symptom State (PASS) for function, walking difficulties, fear of movement, wish for surgery, pain medication use, physical function measured by the 30s chair-stand test, and level of physical activity. Educational attainment was used as a socioeconomic measure and the concentration index was used to assess the magnitude of inequalities at baseline and 3 month follow-up. Results The study included 21,688 participants (mean ± sd age 64.1 ± 9.1 years, 74.4% females). All outcomes except for PASS demonstrated inequalities in favour of highly educated participants at both time-points, with highly educated participants reporting better outcomes. At 3 month follow-up, the magnitude of inequality widened for activity impairment, but narrowed for NRS pain, EQ-5D-5L, KOOS-12/HOOS-12 Pain and Function, physical function, and wish for surgery. There were no statistically conclusive changes in the magnitude of inequalities for the remaining outcomes. Conclusions There were inequalities in patient-related outcomes in favour of those with higher education among participants of a digital self-management intervention for OA, although the magnitude of these pre-existing inequalities generally narrowed after the 3 month intervention.

Digital interventions for self-management of prediabetes: A scoping review.

Rates of prediabetes, which can lead to type 2 diabetes, are increasing worldwide. Interventions for prediabetes mainly focus on lifestyle changes to diet and exercise. While these interventions are effective, they are often delivered face-to-face, which may pose a barrier to those with limited access to healthcare. Given the evidence for digital interventions addressing other noncommunicable diseases, these may also be effective for prediabetes self-management. The aim of this scoping review was to assess the breadth of evidence around digital interventions for prediabetes self-management. We developed a targeted search strategy and relevant studies were identified through searches conducted in four bibliographic databases (Medline, Embase, PsycInfo, and Scopus). Published studies were eligible if they included a digital intervention to support adults aged 18+ with prediabetes self-management. Titles and abstracts were first screened for relevance by one researcher. Full texts of selected records were assessed against the review criteria independently by two researchers for inclusion in the final analysis. Twenty-nine studies were included, of which nine were randomised controlled trials. Most efficacy studies reported significant changes in at least one primary and/or secondary outcome, including participants' glycaemic control, weight loss and/or physical activity levels. About one-third of studies reported mixed outcomes or early significant outcomes that were not sustained at long-term follow-up. Interventions varied in length, digital modalities, and complexity. Delivery formats included text messages, mobile apps, virtually accessible dietitians/health coaches, online peer groups, and web-based platforms. Approximately half of studies assessed participant engagement/acceptability outcomes. Whilst the evidence here suggests that digital interventions to support prediabetes self-management are acceptable and have the potential to reduce one's risk of progression to type 2 diabetes, more research is needed to understand which interventions, and which components specifically, have the greatest reach to diverse populations, are most effective at promoting user engagement, and are most effective in the longer term.

A multicenter randomized controlled feasibility trial of a digital self-management intervention for adults with epilepsy.

Self-management interventions may enhance health-related quality of life (HRQoL) in epilepsy. However, several barriers often impair their implementation in the real world. Digital interventions may help to overcome some of these barriers. Considering this, the Helpilepsy Plus Prototype was developed as a prototype smartphone-delivered self-care treatment program for adults with epilepsy. The 12-week Helpilepsy Plus Prototype was evaluated through a randomized controlled feasibility trial with a waiting-list control (WLC) group. Outcome measurement at baseline and at 12 weeks assessed adherence to the prototype intervention and changes in epilepsy-related outcomes. The primary endpoint was patient autonomy measured with EASE, and secondary endpoints included HRQoL measured with QOLIE-31, health literacy measured with HLQ, anxiety, and depression symptoms measured with HADS. Semi-structured interviews were conducted with a heterogeneous sample of participants to assess user-friendliness and usefulness. The prototype program was delivered through the Neuroventis Platform (Neuroventis, BV, Overijse, Belgium), a certified medical device (under EU/MDD Class I, and EU/MDR grace period). Ninety-two patients were included (46 in the intervention group, 46 in WLC). Most participants (63%, 58/92 women, median age 30 years) had pharmacoresistant epilepsy (61%, 56/92). Only 22% of participants (10/46) in the intervention group completed at least half of all intervention sessions. No significant differences between the intervention group and WLC were observed. Although there was a larger proportion of patients in the intervention group with meaningful improvements in HRQoL compared to WLC (19/46 versus 11/46), the difference was not significant (p = 0.119). Qualitative feedback showed that participants would appreciate more personalization, such as adaptation of the content to their current epilepsy knowledge level, a more interactive interface, shorter text sections, and interaction through reminders and notifications. Digital interventions should allow sufficient scope for personalization and interaction to increase patient engagement and enable benefits from self-care apps. Feedback loops allow the participatory development of tailored interventions. In this study, we investigated the effectiveness of an app-based self-help intervention. Study participants were either randomly assigned to a group that had access to the app or a group that received access to the app after the end of the study. Although a larger proportion of participants in the intervention group showed a relevant improvement in quality of life, the difference between the two groups was not statistically significant. Less than one-fifth of participants in the intervention group attended at least half of all intervention sessions; patient feedback showed that patients required more personalization and interactive options.

Breathing tech: digital health innovations for managing asthma-related psychological dimensions

The paper aimed to provide a comprehensive overview of the use of digital health technologies in the assessment, treatment, and self-management of psychological and psychopathological factors associated with asthma. A collection of research articles and systematic reviews related to asthma, including topics such as outdoor air pollution, early life wheezing illnesses, atopic dermatitis, digital interventions for asthma self-management, psychiatric disorders and asthma, family influences on pediatric asthma, and the use of mobile health (mHealth) applications for asthma management, were analyzed. Eight selected studies were reviewed to assess the potential of digital health technologies in improving asthma psychological-related factors management and treatment outcomes. The reviewed studies suggest that electronic health (eHealth) interventions, mixed reality tools, mHealth technology-enhanced nurse-guided interventions, and smartphone applications integrating Bluetooth-enabled sensors for asthma inhalers can significantly improve symptom self-management, quality of life, and mental health outcomes, especially in children and adolescents with asthma (JMIR Pediatr Parent. 2019;2:e12427. doi: 10.2196/12427; Cochrane Database Syst Rev. 2018;8:CD012489. doi: 10.1002/14651858.CD012489.pub2; Int J Environ Res Public Health. 2020;17:7750. doi: 10.3390/ijerph17217750; J Med Internet Res. 2017;19:e113. doi: 10.2196/jmir.6994; J Med Internet Res. 2021;23:e25472. doi: 10.2196/25472; Ann Allergy Asthma Immunol. 2015;114:341–2.E2. doi: 10.1016/j.anai.2014.12.017; J Med Internet Res. 2022;24:e38030. doi: 10.2196/38030; Int J Qual Methods. 2021;20:16094069211008333. doi: 10.1177/16094069211008333). However, further research is needed to determine their effectiveness and feasibility in different populations and settings. Tailored interventions that address the specific needs and preferences of patients with asthma and associated psychological factors are crucial for ensuring sustained and equitable use of these technologies. The manuscript emphasizes the importance of addressing psychological factors in the management and treatment of asthma and call for continued research and development in this area.

Implementation frameworks guiding digital self-management intervention in chronic pain: A scoping review.

The development, evaluation and implementation of digital self-management interventions for chronic pain have increased exponentially. While intervention outcomes appear promising to improve well-being and functioning in target populations, it is unclear how the development and evaluation processes were structured and how implementation was planned and executed. The aim of this systematic review is to provide a comprehensive overview of implementation frameworks used to guide and evaluate scientific innovation in chronic pain. Four bibliography databases (Medline, Web of Science, PsycInfo, CINAHL) and two registries (PubMed Central, MedaRxiv) were systematically searched. Hits (n = 6830) and full texts (n = 351) were screened and read by two independent reviewers. Peer-reviewed articles that met the inclusion criteria were included in the narrative synthesis. In total, 10 studies were identified that report on seven distinct interventions. Five implementation frameworks were utilized across these studies: Behavioural Interventions using Technology (BIT); Consolidated Framework for Implementation Research (CFIR); mHealth Agile and User-Centered Research and Development Lifecycle; Medical Research Council (MRC); Reach, Effectiveness, Adoption Implementation, and Maintenance (RE-AIM). Frameworks were operationalized using qualitative and quantitative methods, evaluating the innovation on various levels (e.g., individual vs. organizational) and applying a variety of study designs (e.g., single-arm or large trials). By utilizing implementation frameworks, access to evidence-based chronic pain care may be increased. Although the evidence on the utility of implementation frameworks to guide and evaluate digital self-management interventions is still limited, the body of literature is increasing. Future studies are urged to operationalize, communicate and discuss the innovation process, to promote transparency and replicability. The use of implementation frameworks to guide and evaluate digital self-management interventions for chronic pain is a recent development in the field. Several promising examples exist and are presented in this review. Currently, the evidence is still limited, and prospective studies need to transparently operationalize, communicate and discuss their efforts. By utilizing an implementation framework, promising interventions can be made available to end-users, closing the research-to-clinical practice gap and increasing access to evidence-based care to people with chronic pain.

Patient acceptable symptom state and treatment failure threshold values for work productivity and activity Impairment and EQ-5D-5L in osteoarthritis

ObjectiveTo estimate patient acceptable symptom state (PASS) and treatment failure (TF) threshold values for Work Productivity and Activity Impairment (WPAI) measure and EQ-5D-5L among people with hip or knee osteoarthritis (OA) 3 and 12 months following participation in a digital self-management intervention (Joint Academy®).MethodsAmong the participants, we computed work and activity impairments scores (both 0–100, with a higher value reflecting higher impairment) and the Swedish hypothetical- (range: − 0.314 to 1) and experience-based (range: 0.243–0.976) EQ-5D-5L index scores (a higher score indicates better health status) at 3- (n = 14,607) and 12-month (n = 2707) follow-ups. Threshold values for PASS and TF were calculated using anchor-based adjusted predictive modeling. We also explored the baseline dependency of threshold values according to pain severity at baseline.ResultsAround 42.0% and 48.3% of the participants rated their current state as acceptable, while 4.2% and 2.8% considered the treatment had failed at 3 and 12 months, respectively. The 3-month PASS/TF thresholds were 16/29 (work impairment), 26/50 (activity impairment), 0.92/0.77 (hypothetical EQ-5D-5L), and 0.87/0.77 (the experience-based EQ-5D-5L). The thresholds at 12 months were generally comparable to those estimated at 3 months. There were baseline dependencies in PASS/TF thresholds with participants with more severe baseline pain considering poorer (more severe) level of WPAI/EQ-5D-5L as satisfactory.ConclusionPASS and TF threshold values for WPAI and EQ-5D-5L might be useful for meaningful interpretation of these measures among people with OA. The observed baseline dependency of estimated thresholds limits their generalizability and values should be applied with great caution in other settings/populations.

Behavior Change Techniques Within Digital Interventions for the Treatment of Eating Disorders: Systematic Review and Meta-Analysis.

Previous systematic reviews of digital eating disorder interventions have demonstrated effectiveness at improving symptoms of eating disorders; however, our understanding of how these interventions work and what contributes to their effectiveness is limited. Understanding the behavior change techniques (BCTs) that are most commonly included within effective interventions may provide valuable information for researchers and developers. Establishing whether these techniques have been informed by theory will identify whether they target those mechanisms of action that have been identified as core to changing eating disorder behaviors. It will also evaluate the importance of a theoretical approach to digital intervention design. This study aims to define the BCTs within digital self-management interventions or minimally guided self-help interventions for adults with eating disorders that have been evaluated within randomized controlled trials. It also assessed which of the digital interventions were grounded in theory and the range of modes of delivery included. A literature search identified randomized controlled trials of digital intervention for the treatment of adults with eating disorders with minimal therapist support. Each digital intervention was coded for BCTs using the established BCT Taxonomy v1; for the application of theory using an adapted version of the theory coding scheme (TCS); and for modes of delivery using the Mode of Delivery Ontology. A meta-analysis evaluated the evidence that any individual BCT moderated effect size or that other potential factors such as the application of theory or number of modes of delivery had an effect on eating disorder outcomes. Digital interventions included an average of 14 (SD 2.6; range 9-18) BCTs. Self-monitoring of behavior was included in all effective interventions, with Problem-solving, Information about antecedents, Feedback on behavior, Self-monitoring of outcomes of behavior, and Action planning identified in >75% (13/17) of effective interventions. Social support and Information about health consequences were more evident in effective interventions at follow-up compared with postintervention measurement. The mean number of modes of delivery was 4 (SD 1.6; range 2-7) out of 12 possible modes, with most interventions (15/17, 88%) being web based. Digital interventions that had a higher score on the TCS had a greater effect size than those with a lower TCS score (subgroup differences: χ21=9.7; P=.002; I²=89.7%) within the meta-analysis. No other subgroup analyses had statistically significant results. There was a high level of consistency in terms of the most common BCTs within effective interventions; however, there was no evidence that any specific BCT contributed to intervention efficacy. The interventions that were more strongly informed by theory demonstrated greater improvements in eating disorder outcomes compared to waitlist or treatment-as-usual controls. These results can be used to inform the development of future digital eating disorder interventions. PROSPERO CRD42023410060; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=410060.

Sex and age differences in the patient-reported outcome measures and adherence to an osteoarthritis digital self-management intervention

ObjectiveTo explore sex and age differences in Patient-Reported Outcomes Measures (PROMs) and adherence to digital osteoarthritis (OA) self-management intervention. MethodsA register-based study with data from an OA digital self-management intervention. PROMs and adherence were collected at baseline and/or 3 ​month follow-up: ‘pain intensity’ in hip/knee (best/worst: 0–10), ‘activity impairments' (best/worst: 0–10), ‘overall health’ perception (worst/best: 0–10), ‘physical function’ (30-s chair stand test), ‘health-related quality of life’ (EQ-5D-5L index score; worst/best: 0.243–0.976), the subscales and total scores of the Knee Injury/Hip Disability and Osteoarthritis Outcome Score (KOOS/HOOS-12; worst/best: 0–100), ‘fear of movement’ (yes/no), ‘walking difficulties' (yes/no), ‘programme adherence’ (0–100 ​% and ≥80 ​% [yes/no]), ‘patient acceptable symptom state’ (PASS; yes/no), and ‘treatment failure’ (those who answered no to PASS question and thought the treatment failed [yes/no]). We used linear/logistic regression to calculate mean/risk differences in the PROMs and adherence levels among sex and age groups at 3-month follow-up. We employed entropy balancing to explore the contributions of baseline characteristics and different covariates to the sex/age differences. ResultsWe included 14,610 participants (mean (SD) age: 64.1 (9.1), 75.5 ​% females). Females generally reported better outcomes than males. Participants aged ≥70 had greater activity impairments, lower KOOS/HOOS-pain/function scores, more walking difficulties, less fear of movement and higher adherence than those <70. However, these differences were small and not likely clinically relevant. ConclusionNo clinically relevant differences in PROMs and adherence were found among sex/age groups in this digital OA programme, suggesting that sex/age seemed not to impact the outcomes of this intervention.

P651 A randomised controlled trial of IBD-BOOST, a digital cognitive behavioural self-management programme for fatigue, and/or pain, and/or faecal incontinence in inflammatory bowel disease

Abstract Background Many people with IBD experience fatigue, pain and faecal incontinence (FI), impacting quality of life (QoL). We developed an interactive digital online self-management intervention (IBD-BOOST) based on a theoretically informed logic model and cognitive behavioural techniques, to treat these symptoms. We aimed to assess if IBD-BOOST, alongside health care professional (HCP) support and care as usual (CAU), provides greater relief from symptoms and improvement of QoL compared with CAU alone. Methods We conducted a pragmatic multi-centre two-arm parallel group randomised controlled trial (RCT) recruiting patients from clinics and national registries who rated the impact of fatigue and/or pain and/or FI as ≥5/10. Those in the IBD-BOOST arm received 6 months access to the 12-session IBD-BOOST programme, a 30-minute telephone support call with a trained HCP after session 1 and weekly in-site email messages from the HCP for 3 months. The UK Inflammatory Bowel Disease Questionnaire (UK-IBDQ) and global rating of symptom relief (GRSR) at 6 months were dual primary outcomes (alpha=0.025 was considered statistically significant as there were two primary outcomes). Other secondary outcomes, including individual symptoms, were measured at 6 and 12 months. Complier-averaged causal effects (CACE), sensitivity and pre-specified subgroup analyses were conducted. Results 780 participants were randomised (Figure 1), 432 with Crohn’s disease, 348 with ulcerative colitis or other IBD; 520 (66.7%) were female, mean age 49 years. At 6 months, both UK-IBDQ and GRSR were similar between the BOOST and CAU arms, p=0.19 for IBDQ and p=0.39 for GRSR (Table 1). Adverse events were similar between groups. FI score and EQ5D utility score (secondary outcomes) were significantly in favour of IBD-BOOST at 6 months, but pain and fatigue were no different. 57% of the intervention group completed a pre-defined minimum “dose” of 4 sessions (i.e. compliers). The CACE analysis suggested that compliers were more likely to report better QoL (p=0.03). Subgroup analysis of those meeting criteria for irritable bowel syndrome (IBS), showed that IBD-BOOST was more effective in improving IBDQ and GRSR at 6 months when compared with CAU for the IBD-IBS group (pinteraction=0.015 and 0.046, respectively). Conclusion This large RCT found that IBD-BOOST did not improve IBDQ and GRSR in patients with IBD and fatigue and/or pain and/or FI relative to CAU. Participants reported less FI at 6 and 12 months. Those who complied with the intervention showed a more pronounced IBDQ treatment effect. Those with IBD-IBS at baseline improved more than those without, suggesting a possible for further effectiveness research on IBD-BOOST. Trial registration: ISRCTN71618461

Exploring the feasibility, acceptability, usability and safety of a digitally supported self-management intervention for uncontrolled asthma: A pre-post pilot study in secondary care.

Asthma control is often suboptimal, which is associated with incorrect medication use and poor asthma management by patients. Astmakompas, a digital self-management intervention, comprises a mobile app for patients, a web portal for healthcare professionals (HCP), and a wireless spirometer. Together, these components are intended to facilitate symptom monitoring, patient-HCP communication and assist in asthma-related self-management. The pilot study primarily aims to assess the feasibility, acceptability, usability and safety of Astmakompas from patient and HCP perspectives, and secondarily to explore potential effects on asthma control, medication use, Quality of Life, self-efficacy and (in)direct costs. A mixed-method, multi-center, pre-post study design was conducted in two Dutch hospitals, involving patients with uncontrolled asthma and four HCPs. Primary outcomes were assessed post-intervention using questionnaires and in-depth interviews. Secondary outcomes were assessed at baseline and post-intervention using questionnaires, and post-intervention using in-depth interviews. In general, the data show that Astmakompas was considered feasible, acceptable, usable and safe by both patients (n = 14) and HCPs (n = 4). Furthermore, qualitative data of 11 patients and all HCPs showed the importance of guidance from HCPs and tailoring of Astmakompas to care needs. Astmakompas helped patients recognise symptoms and provided valuable insights into asthma control while being easy to use. Asthma control improved from baseline (M = 2.1, SD = 1.3) to post-intervention (M = 1.3, SD = 1.0, t(13) = 2.61; p = .02). Astmakompas shows promise for further implementation and research. Future randomized studies with longer evaluation periods are crucial to assess the tool's impact on asthma outcomes and workload. It is important that HCPs guide and tailor interventions to meet the patient's individual needs and circumstances.

Digital Interventions for Relapse Prevention, Illness Self-Management, and Health Promotion In Schizophrenia: Recent Advances, Continued Challenges, and Future Opportunities

Digital Interventions for Relapse Prevention, Illness Self-Management, and Health Promotion In Schizophrenia: Recent Advances, Continued Challenges, and Future Opportunities

Understanding Whether and How a Digital Health Intervention Improves Transition Care for Emerging Adults Living With Type 1 Diabetes: Protocol for a Mixed Methods Realist Evaluation.

Emerging adults living with type 1 diabetes (T1D) face a series of challenges with self-management and decreased health system engagement, leading to an increased risk of acute complications and hospital admissions. Effective and scalable strategies are needed to support this population to transfer seamlessly from pediatric to adult care with sufficient self-management capability. While digital health interventions for T1D self-management are a promising strategy, it remains unclear which elements work, how, and for which groups of individuals. This study aims to evaluate the design and implementation of a multicomponent SMS text message-based digital health intervention to support emerging adults living with T1D in real-world settings. The objectives are to identify the intervention components and associated mechanisms that support user engagement and T1D health care transition experiences and determine the individual characteristics that influence the implementation process. We used a realist evaluation embedded alongside a randomized controlled trial, which uses a sequential mixed methods design to analyze data from multiple sources, including intervention usage data, patient-reported outcomes, and realist interviews. In step 1, we conducted a document analysis to develop a program theory that outlines the hypothesized relationships among "individual-level contextual factors, intervention components and features, mechanisms, and outcomes," with special attention paid to user engagement. Among them, intervention components and features depict 10 core characteristics such as transition support information, problem-solving information, and real-time interactivity. The proximal outcomes of interest include user engagement, self-efficacy, and negative emotions, whereas the distal outcomes of interest include transition readiness, self-blood glucose monitoring behaviors, and blood glucose. In step 2, we plan to conduct semistructured realist interviews with the randomized controlled trial's intervention-arm participants to test the hypothesized "context-intervention-mechanism-outcome" configurations. In step 3, we plan to triangulate all sources of data using a coincidence analysis to identify the necessary combinations of factors that determine whether and how the desired outcomes are achieved and use these insights to consolidate the program theory. For step 1 analysis, we have developed the initial program theory and the corresponding data collection plan. For step 2 analysis, participant enrollment for the randomized controlled trial started in January 2023. Participant enrollment for this realist evaluation was anticipated to start in July 2023 and continue until we reached thematic saturation or achieved informational power. Beyond contributing to knowledge on the multiple pathways that lead to successful engagement with a digital health intervention as well as target outcomes in T1D care transitions, embedding the realist evaluation alongside the trial may inform real-time intervention refinement to improve user engagement and transition experiences. The knowledge gained from this study may inform the design, implementation, and evaluation of future digital health interventions that aim to improve transition experiences. PRR1-10.2196/46115.

Using Intervention Mapping and Behavior Change Techniques to Develop a Digital Intervention for Self-Management in Stroke: Development Study.

Digital therapeutics, such as interventions provided via smartphones or the internet, have been proposed as promising solutions to support self-management in persons with chronic conditions. However, the evidence supporting self-management interventions through technology in stroke is scarce, and the intervention development processes are often not well described, creating challenges in explaining why and how the intervention would work. This study describes a specific use case of using intervention mapping (IM) and the taxonomy of behavior change techniques (BCTs) in designing a digital intervention to manage chronic symptoms and support daily life participation in people after stroke. IM is an implementation science framework used to bridge the gap between theories and practice to ensure that the intervention can be implemented in real-world settings. The taxonomy of BCTs consists of a set of active ingredients designed to change self-management behaviors. We used the first 4 steps of the IM process to develop a technology-supported self-management intervention, interactive Self-Management Augmented by Rehabilitation Technologies (iSMART), adapted from a face-to-face stroke-focused psychoeducation program. Planning group members were involved in adapting the intervention. They also completed 3 implementation measures to assess the acceptability, appropriateness, and feasibility of iSMART. In step 1, we completed a needs assessment consisting of assembling a planning group to codevelop the intervention, conducting telephone surveys of people after stroke (n=125) to identify service needs, and performing a systematic review of randomized controlled trials to examine evidence of the effectiveness of digital self-management interventions to improve patient outcomes. We identified activity scheduling, symptom management, stroke prevention, access to care resources, and cognitive enhancement training as key service needs after a stroke. The review suggested that digital self-management interventions, especially those using cognitive behavioral theory, effectively reduce depression, anxiety, and fatigue and enhance self-efficacy in neurological disorders. Step 2 identified key determinants, objectives, and strategies for self-management in iSMART, including knowledge, behavioral regulation, skills, self-efficacy, motivation, negative and positive affect, and social and environmental support. In step 3, we generated the intervention components underpinned by appropriate BCTs. In step 4, we developed iSMART with the planning group members. Especially, iSMART simplified the original psychoeducation program and added 2 new components: SMS text messaging and behavioral coaching, intending to increase the uptake by people after stroke. iSMART was found to be acceptable (mean score 4.63, SD 0.38 out of 5), appropriate (mean score 4.63, SD 0.38 out of 5), and feasible (mean score 4.58, SD 0.34 out of 5). We describe a detailed example of using IM and the taxonomy of BCTs for designing and developing a digital intervention to support people after stroke in managing chronic symptoms and maintaining active participation in daily life.

Using the behaviour change wheel and person-based approach to develop a digital self-management intervention for patients with adrenal insufficiency: the Support AI study protocol.

Most patients with Adrenal insufficiency (AI) require lifelong glucocorticoid replacement. They need to increase glucocorticoids during physical illness or major stressful situations and require parenteral hydrocortisone in the event of an adrenal crisis. Patients with AI have impaired quality of life and high mortality; approximately 1 in 6-12 patients are hospitalised at least once/year from a potentially preventable adrenal crisis. Adoption of self-management behaviours are crucial; these include adherence to medication, following "sick day rules" and associated behaviours that aid prevention and treatment of adrenal crisis such as symptom monitoring, having extra tablets, carrying a medical-alert ID and injection kit, and self-injecting when necessary. Current patient education is ineffective at supporting self-management behaviour change or reducing adrenal crisis-related hospitalisations. This research study aims to gain an in-depth understanding of the barriers and enablers to self-management for patients with AI and to develop an evidence-based digital self-management behaviour change intervention. The study is conducted in accordance with the MRC Framework for developing complex interventions. Underpinned by the Behaviour Change Wheel (BCW), the Theoretical Domains Framework (TDF), and the Person-Based Approach, this research will be conducted in two phases: Phase 1 will involve a sequential qualitative/quantitative mixed-methods study involving focus group interviews followed by a cross-sectional survey with patients with AI recruited from patient advocacy groups and endocrine clinics in the UK. Phase 2 will develop the Support AI, a website-based digital behaviour change intervention (DBCI) informed by Phase 1 findings to support self-management for patients with AI. The most appropriate behaviour change techniques (BCTs) will be selected utilising a nominal group technique with an Expert Panel of 10-15 key stakeholders. The design of the Support AI website will be guided by the Person-Based Approach using an Agile iterative "think-aloud" technique with 12-15 participants over 3 usability testing iterations. A theory- and evidence-based digital behaviour change intervention will be developed which will be tested in a feasibility randomised trial following completion of this study. The projected benefit includes cost-effective health care service (reduced hospitalisations and demand for specialist services) and improved health outcomes and quality of life for patients with AI.