Component Of Self-management Research Articles

Self-management of Epilepsy: A Systematic Review.

Although self-management is recommended for persons with epilepsy, its optimal strategies and effects are uncertain. To evaluate the components and efficacy of self-management interventions in the treatment of epilepsy in community-dwelling persons. English-language searches of MEDLINE, Cochrane Central Register of Controlled Trials, PsycINFO, and CINAHL in April 2018; the MEDLINE search was updated in March 2019. Randomized and nonrandomized comparative studies of self-management interventions for adults with epilepsy. An investigator assessed study characteristics; intervention details, including 6 components of self-management; and outcomes, which were verified by a second reviewer. Risk of bias (ROB) was assessed independently by 2 investigators. 13 randomized and 2 nonrandomized studies (2514 patients) evaluated self-management interventions. Interventions were delivered primarily in group settings, used a median of 4 components, and followed 2 general strategies: 1 based on education and the other on psychosocial therapy. Education-based approaches improved self-management behaviors (standardized mean difference, 0.52 [95% CI, 0.0 to 1.04]), and psychosocial therapy-based approaches improved quality of life (mean difference, 6.64 [CI, 2.51 to 10.77]). Overall, self-management interventions did not reduce seizure rates, but 1 educational intervention decreased a composite of seizures, emergency department visits, and hospitalizations. High ROB in most studies, incomplete intervention descriptions, and studies limited to English-language publications. There is limited evidence that self-management strategies modestly improve some patient outcomes that are important to persons with epilepsy. Overall, self-management research in epilepsy is limited by the range of interventions tested, the small number of studies using self-monitoring technology, and uncertainty about components and strategies associated with benefit. U.S. Department of Veterans Affairs. (PROSPERO: CRD42018098604).

스포츠지도자들의 자기관리 구성요인 탐색 : 사격 · 양궁중심

스포츠지도자들의 자기관리 구성요인 탐색 : 사격 · 양궁중심

Impact of health service interventions on acute hospital use in community-dwelling persons with dementia: A systematic literature review and meta-analysis.

BackgroundPersons with dementia have twice the acute hospital use as older persons without dementia. In addition to straining overburdened healthcare systems, acute hospital use impacts patient and caregiver quality of life and is associated with increased risk of adverse outcomes including death. Reducing avoidable acute hospital use in persons with dementia is thus a global healthcare priority. However, evidence regarding the impact of health service interventions as defined by the Effective Practice and Organization of Care Cochrane Group on acute hospital use is scant and inconclusive. The aim of this systematic review and meta-analysis was to synthesize available evidence on the impact of health service interventions on acute hospital use in community-dwelling persons with dementia compared to usual care.MethodsData Sources: MEDLINE, EMBASE, CINAHL and Cochrane CENTRAL (from 01/1995 to 08/2017). Study eligibility criteria: Randomised controlled trials measuring the impact of health service interventions on acute hospital use (proportion and mean number of emergency department visits and hospitalisations, mean number of hospital days, measured at 12 months, and at longest follow-up) in community-dwelling persons with dementia, compared to usual care. Study selection, appraisal and synthesis methods: Reviewers independently identified studies, extracted data, and assessed the risk of bias, with the Cochrane risk of bias tool. Authors of relevant trials were queried about unpublished data. Random effects model was used for meta-analyses. Effect heterogeneity was assessed through prediction intervals, and explored using sub-group analyses.FindingsSeventeen trials provided data on 4,549 persons. Unpublished data were obtained for 13 trials, representing 65% of synthesized data. Most interventions included a case management or a self-management component. None of the outcome comparisons provided conclusive evidence supporting the hypothesis that these interventions would lead to a decrease in acute hospital use. Furthermore, prediction intervals indicated possible and important increased service use associated with these interventions, such as emergency department visits, hospital admissions, and hospital days. Subgroup analyses did not favour any type of intervention. A limitation of this study is the inclusion of any type of health service intervention, which may have increased the observed heterogeneity.ConclusionDespite a comprehensive systematic review and meta-analysis, including predominantly unpublished data, no health service intervention beyond usual care was found to reduce acute hospital use in community-dwelling persons with dementia. An important increase in service use may be associated with these interventions. Further research is urgently needed to identify effective interventions for this vulnerable population to limit rising acute hospital use, associated costs and adverse outcomes. Systematic review registration PROSPERO CRD42016046444.

Self-management in condition-specific health: a systematic review of the evidence among women diagnosed with endometriosis

BackgroundEndometriosis is a chronic condition, requiring long-term care as there is no cure. Self-management is the active participation of a person in managing their chronic condition and has been associated with improved knowledge, self-efficacy, performance of self-management tasks and some aspects of health status in interventions for other chronic diseases. The aim was to review the available evidence about the impact of self-management on condition-specific health among women with endometriosis.MethodsThe Medline, PsycINFO, CinahlPlus, Web of Science and Scopus databases were searched and PRISMA guidelines were followed. Search terms were entered both as keywords and mapped to individual database subject headings. Inclusion criteria were: papers that reported investigations of any approach to self-management; among women (at least 18 years) diagnosed with endometriosis and published in English in a peer-reviewed journal. All study designs using quantitative or qualitative methods were eligible for inclusion. Two reviewers independently examined the quality of studies using standard criteria. The systematic review was registered with Prospero (CRD42016042028).ResultsA total of 1164 records were identified (after duplicates were removed), and 27 papers, reporting 19 studies met inclusion criteria. Two papers reported findings from RCTs of complementary therapies, seven reported survey data and 18 qualitative studies. No study had investigated all elements of self-management. Women with endometriosis utilise a range of self-care activities and complementary therapies to assist them to manage their symptoms. Women reported both positive and negative experiences with health care providers.ConclusionsThere is some evidence that self-care activities, complementary therapies and positive patient–healthcare provider relationships are important components of self-management for endometriosis. Self-management among women with endometriosis is an emerging field of research and no investigations of all elements of self-management, informed by a comprehensive definition and theoretical framework are available. Health and wellbeing outcomes and barriers and facilitators to self-management for women with endometriosis require further investigation.

Utilizing the Ambulatory Glucose Profile to Standardize and Implement Continuous Glucose Monitoring in Clinical Practice.

Use of continuous glucose monitoring (CGM) is recognized as a valuable component of diabetes self-management and is increasingly considered a standard of care for individuals with diabetes who are treated with intensive insulin therapy. As the clinical use of CGM technology expands, consistent and standardized glycemic metrics and glucose profile visualization have become increasingly important. A common set of CGM metrics has been proposed by an international expert panel in 2017, including standard definitions of time in ranges, glucose variability, and adequacy of data collection. We describe the core CGM metrics, as well as the standardized glucose profile format consolidating 2 weeks of CGM measurements, referred to as the ambulatory glucose profile (AGP), which was also recommended by the CGM expert panel. We present an updated AGP report featuring the core CGM metrics and a visualization of glucose patterns that need clinical attention. New tools for use by clinicians and patients to interpret AGP data are reviewed. Strategies based on the authors' experience in implementing CGM technology across the clinical care spectrum are highlighted.

Implementing a self-management mobile app for spinal cord injury during inpatient rehabilitation and following community discharge: A feasibility study

Objective: To determine the feasibility of implementing and evaluating a self-management mobile app for spinal cord injury (SCI) during inpatient rehabilitation and following community discharge. Design: Pilot feasibility study. Setting: Rehabilitation hospital and community. Participants: Inpatients from rehabilitation hospital following admission for their first SCI. Intervention: A mobile app was developed to facilitate self-management following SCI. The app consisted of 18 tools focusing on goal setting, tracking various health aspects, and identifying confidence regarding components of self-management. In-person training and follow-up sessions were conducted during inpatient rehabilitation and follow-up calls were provided after participants were discharged into the community. Main outcome measures: Participants completed outcome measures at baseline, community discharge, and 3-months post discharge. This study focused on feasibility indicators including recruitment, retention, respondent characteristics, adherence, and app usage. Additionally, participants’ self-management confidence relating to SCI (e.g. medication, skin, bladder, pain) was evaluated over time. Results: Twenty participants (median age 39, IQR: 31 years, 85% male) enrolled in the study. Participants’ Spinal Cord Injury Independence Measure (SCIM-III) median score was 23 and IQR was 33 (range: 7–84), which did not correlate with app usage. Retention from admission to discharge was 85% and 70% from discharge to 3-months post discharge. Individuals in the study who used the app entered data an average of 1.7x/day in rehabilitation (n = 17), and 0.5x/day in the community (n = 7). Participants’ bowel self-management confidence improved between admission and discharge (P < 0.01). Conclusions: Feasibility indicators support a larger clinical trial during inpatient rehabilitation; however, there were challenges with retention and adherence following community discharge.

Conformity of Diabetes Mobile apps with the Chronic Care Model

BackgroundDespite the growing use of mobile applications (apps) for chronic disease management, the evidence on the effectiveness of this technology on clinical and behavioural outcomes of the patients is scant....

The effectiveness of self-management interventions in adults with chronic orofacial pain: A systematic review, meta-analysis and meta-regression.

Psychosocial risk factors associated with chronic orofacial pain are amenable to self-management. However, current management involves invasive therapies which lack an evidence base and has the potential to cause iatrogenic harm. To determine: (a) whether self-management is more effective than usual care in improving pain intensity and psychosocial well-being and (b) optimal components of self-management interventions. Cochrane Oral Health Group Trials Register, Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, PsycINFO, WHO International Clinical Trials Registry Platform and Clinical Trials.gov were searched. Meta-analysis was used to determine effectiveness, and GRADE was used to rate quality, certainty and applicability of evidence. Fourteen trials were included. Meta-analyses showed self-management was effective for long-term pain intensity (standardized mean difference [SMD] -0.32, 95% confidence interval [CI] -0.47 to -0.17) and depression (SMD -0.32, 95% CI -0.50 to -0.15). GRADE analysis showed a high score for certainty of evidence for these outcomes and significant effects for additional outcomes of activity interference (-0.29 95% CI -0.47 to -0.11) and muscle palpation pain (SMD -0.58 95% CI -0.92 to -0.24). Meta-regression showed nonsignificant effects for biofeedback on long-term pain (-0.16, 95% CI -0.48 to 0.17, p-value=0.360) and depression (-0.13, 95% CI -0.50 to 0.23, p-value=0.475). Self-management interventions are effective for patients with chronic orofacial pain. Packages of physical and psychosocial self-regulation and education appear beneficial. Early self-management of chronic orofacial pain should be a priority for future testing. This systematic review provides clear evidence for effectiveness of combined biomedical and psychological interventions (incorporating self-management approaches) on long-term outcomes in the management of chronic orofacial (principally TMD) pain. Self-management should be a priority for early intervention in primary care in preference to invasive, irreversible and costly therapies. Further research is needed firstly to clarify the relative effectiveness of specific components of self-management, both individually and in conjunction, and secondly on outcomes in other types of chronic orofacial pains.

Patterns and Perceptions of Self-Management for Osteoarthritis Pain in African American Older Adults.

To explore and describe older African Americans' patterns and perceptions of managing chronic osteoarthritis pain. A convergent parallel mixed-methods design incorporating cross-sectional surveys and individual, semistructured interviews. One hundred ten African Americans (≥50 years of age) with clinical osteoarthritis (OA) or provider-diagnosed OA from communities in northern Louisiana were enrolled. Although frequency varied depending on the severity of pain, older African Americans actively used an average of seven to eight self-management strategies over the course of a month to control pain. The average number of self-management strategies between high and low education and literacy groups was not statistically different, but higher-educated adults used approximately one additional strategy than those with high school or less. To achieve pain relief, African Americans relied on 10 self-management strategies that were inexpensive, easy to use and access, and generally perceived as helpful: over-the-counter (OTC) topicals, thermal modalities, land-based exercise, spiritual activities, OTC and prescribed analgesics, orthotic and assistive devices, joint injections, rest, and massage and vitamins. This is one of the first studies to quantitatively and qualitatively investigate the self-management of chronic OA pain in an older African American population that happened to be a predominantly higher-educated and health-literate sample. Findings indicate that Southern-dwelling African Americans are highly engaged in a range of different self-management strategies, many of which are self-initiated. Although still an important component of chronic pain self-management, spirituality was used by less than half of African Americans, but use of oral nonsteroidal anti-inflammatory drugs and opioids was relatively high.

The association between hypertension self-management and stroke event in male patients at the Badung District Hospital, Bali

Background and purpose: Hypertension is a major risk factor for stroke. Despite efforts to control hypertension with pharmacological and non-pharmacological therapies, the prevalence of and death from stroke is reported to be increasing. This study aims to determine the association of hypertension self-management with the incidence of stroke in patients with hypertension.Methods: A case-control study was conducted involving 44 patients suffering from hypertension and who had suffered a stroke as a case, as well as 44 patients with hypertension and no stroke as a control. Data on self-management of diet, physical activity, stress mitigation efforts, alcohol consumption, and medication adherence were collected using self administered questionnaire. Data on the diagnosis of hypertension, stroke and history of comorbidities were obtained from the patient's medical records. Multivariatee analysis using logistic regression was employed to assess the association between hypertension self-management with the incidence of stroke in patients with hypertension.Results: Characteristics of cases and controls did not differ in education, marital and socioeconomic status, but differed in age and employment. Multivariate analysis showed that there were three components of hypertension self-management associated with the incidence of stroke, namely poor adherence to medication (AOR=7.28; 95%CI: 2.19-24.17), poor self-management of stress (AOR=5.45; 95%CI: 1.56-18.99), and poor management of self-regulated diet (AOR=5.28; 95%CI: 1.31-21.32).Conclusions: Medication adherence, diet and stress management are the three main components of self-management that are associated with stroke events among hypertension patients. Efforts to increase medication adherence, diet and stress management should be enhanced.

Missed opportunities for physical activity management at key points throughout the chemotherapy pathway for colorectal survivors: an observational interview study.

Physical activity (PA) is central to self-management for people with colorectal cancer (CRC) to support health behaviour and function secondary to cancer treatment. However, there is limited evidence on how health professionals (HPs) promote PA during cancer treatment. This study aimed to investigate how and when PA is promoted throughout the chemotherapy pathway among colorectal cancer survivors. A qualitative study was conducted with adults with CRC receiving chemotherapy at a large cancer centre. Cross-sectional observation of clinical consultations was conducted at four points during the chemotherapy pathway: prior, midpoint, final cycle, and 8weeks following chemotherapy. Following completion of treatment, audio-recorded, semi-structured interviews were conducted with patients and HPs and transcribed verbatim. Codes and themes were identified and triangulated from all the data using framework analysis. Observational themes are reported and complimented by interview data. Throughout the chemotherapy pathway (pre, midpoint, end), many opportunities were missed by HPs to promote PA as a beneficial means to maintain functioning and ameliorate cancer treatment side effects. When discussed, PA levels were used only to determine fitness for future oncological treatment. No PA promotion was observed despite patients reporting low PA levels or treatment side effects. Post-treatment, PA promotion was more routinely delivered by HPs, as evidenced by problem-solving and onward referrals to relevant HPs. PA promotion was largely absent during treatment despite it being a key component of patient self-management following treatment. This suggests considerable missed opportunities for HPs to provide cancer survivors with PA evidence-based interventions. Further research is necessary to identify how best to ensure PA is promoted throughout the cancer journey. These findings suggest many may not be receiving support to be physically active during treatment.

Exploring the Needs of Adolescents With Sickle Cell Disease to Inform a Digital Self-Management and Transitional Care Program: Qualitative Study.

BackgroundAccessible self-management interventions are critical for adolescents with sickle cell disease to better cope with their disease, improve health outcomes and health-related quality of life, and promote successful transition to adult health care services. However, very few comprehensive self-management and transitional care programs have been developed and tested in this population. Internet and mobile phone technologies can improve accessibility and acceptability of interventions to promote disease self-management in adolescents with sickle cell disease.ObjectiveThe aim of this study was to qualitatively explore the following from the perspectives of adolescents, parents, and their health care providers: (1) the impact of sickle cell disease on adolescents to identify challenges to their self-management and transitional care and (2) determine the essential components of a digital self-management and transitional care program as the first phase to inform its development.MethodsA qualitative descriptive design utilizing audio-recorded, semistructured interviews was used. Adolescents (n=19, aged 12-19 years) and parents (n=2) participated in individual interviews, and health care providers (n=17) participated in focus group discussions and were recruited from an urban tertiary care pediatric hospital. Audio-recorded data were transcribed verbatim and organized into categories inductively, reflecting emerging themes using simple content analysis.ResultsData were categorized into 4 major themes: (1) impact of sickle cell disease, (2) experiences and challenges of self-management, (3) recommendations for self-management and transitional care, and (4) perceptions about a digital self-management program. Themes included subcategories and the perspectives of adolescents, parents, and health care providers. Adolescents discussed more issues related to self-management, whereas health care providers and parents discussed issues related to transition to adult health services.ConclusionsAdolescents, parents, and health care providers described the continued challenges youth with sickle cell disease face in terms of psychosocial impacts and stigmatization. Participants perceived a benefit to alleviating some of these challenges through a digital self-management tool. They recommended that an effective digital self-management program should provide appropriate sickle cell disease–related education; guidance on developing self-advocacy and communication skills; empower adolescents with information for planning for their future; provide options for social support; and be designed to be engaging for both adolescents and parents to use. A digital platform to deliver these elements is an accessible and acceptable way to address the self-management and transitional care needs of adolescents.

Asthma Predictors Influence on Self-management Asthma Education Status

Objective The objective of this study was to determine the characteristics of adults with active asthma who were most likely to acquire self-management asthma component education. Methods We analyzed adult data from the 2014 Behavioral Risk Factor Surveillance System (BRFSS)-Asthma Call-back Survey (ACBS). Multivariate logistic regression and multivariate linear regression models were used to analyze the association between asthma self-management education and predictors. Results Adults who had health insurance (aB = 0.33 [SE = 0.15], p < .05), routine care visits (aB = 0.75 [SE = 0.08], p < .05) and hospitalization (aB = 0.50 [SE = 0.23], p < .05) reported higher asthma education scores. Adults aged 18-34 years were more likely to report inhaler use instruction (aOR = 3.9; 95% CI: 2.5-6.3, p < .05), than older adults aged 65 years and older. Having a formal education, being a woman, and being black increased the likelihood of having a higher self-management score. Conclusion Having health insurance, making routine visits, and having asthma episodes were associated with multiple asthma education components which ensures social justice. Asthma control programs need to reexamine asthma education components to make sure they are promoted to persons regardless of their age, education level, or sex."

A Randomized Controlled Pilot Study of a Manualized Intervention for Caregivers of Patients With Traumatic Brain Injury in Inpatient Rehabilitation

ObjectiveInvestigate effectiveness of a 5-session manualized intervention for addressing needs of caregivers of persons in acute traumatic brain injury (TBI) rehabilitation. DesignProspective, pilot randomized controlled trial. SettingInpatient brain injury rehabilitation unit, level 1 trauma center. ParticipantsPatients (N=93) with moderate-to-severe TBI and their family members were enrolled in the study with 42 randomized to the treatment group, 51 to the control group. InterventionFive-session manualized caregiver intervention with educational, stress and anxiety self-management, coping, and emotional support components. Main Outcome MeasuresFamily Needs Questionnaire-Revised, knowledge assessment, Zarit Family Burden Scale, and Brief Symptom Inventory-18 were collected at pretreatment, posttreatment, and 3-month follow-up. ResultsTreatment group caregivers showed an increase in met needs for emotional, instrumental, and professional support, and brain injury knowledge from baseline to posttreatment, whereas controls did not. Between-group differences were significant for only emotional support needs. Treatment effects were not sustained at 3-month follow-up. ConclusionsCaregivers of persons undergoing acute TBI rehabilitation may benefit from interventions that target their unique needs. Caregivers may require additional and longer-term supports to sustain treatment benefits.

An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for the process evaluation of a cluster randomised controlled feasibility trial

BackgroundWhilst pathways relating to the early stages of stroke care have become well established, strategies for longer-term care are less developed and longer-term outcomes remain poor for many stroke survivors. New Start, a complex intervention that includes needs identification, exploration of social networks and components of problem-solving and self-management, was designed to improve stroke survivors’ quality of life by addressing unmet needs and increasing participation. It is delivered approximately 6 months post-stroke by trained staff (facilitators). We are currently undertaking a cluster randomised feasibility trial of the New Start intervention with an embedded process evaluation, which is an important component of the design and testing of complex interventions as it provides an understanding of how interventions are delivered and function in different settings.Methods/designThis mixed methods process evaluation will explore the degree to which New Start is implemented as intended, the impact of context on intervention delivery and the acceptability of the intervention for stroke survivors, their families and practitioners. It will include non-participant observation of facilitator training and intervention delivery. Interviews with stroke survivors, facilitators and other relevant staff (including administrators and managerial staff) will be undertaken. Qualitative data from interview transcripts, facilitator reflections and observational field notes will be analysed thematically alongside numerical data documenting intervention delivery collected as part of the trial.DiscussionThis process evaluation will identify factors that aid and impede implementation of the New Start intervention and improve understanding of this novel approach to longer-term stroke care.Trial registrationISRCTN Registry, ISRCTN38920246. Registered on 22 June 2016.

Feasibility study of a combined lifestyle behaviors and asthma self-management intervention for school-aged children.

The purpose of this study is to test the feasibility of delivering an intervention that combines healthy lifestyle behaviors related to weight management with asthma self-management, the Living Healthy with Asthma intervention, to children who have asthma. Using a mixed design, the feasibility study of the 12-week Living Healthy with Asthma intervention was conducted with a single group of children diagnosed with asthma. Pretest and posttest data were collected on asthma-related (self-management, metered dose inhaler [MDI] skill, asthma severity, quality of life [QOL]), and healthy lifestyle variables (body mass index [BMI], dietary quality). A matched comparison sample was drawn from a separate study that tested the same asthma self-management component (single intervention) used in the feasibility study to determine if the Living Healthy with Asthma intervention worked as well as the single intervention for improving children's asthma self-management. Thirteen school-aged children were enrolled in the feasibility study. There were significant reductions in BMI z-scores (P=0.007), and improvements in vegetable servings (P=0.03), MDI skill (P=0.005), children's QOL (P<0.001), and parents' QOL (P=0.03). When comparing the feasibility group with the matched comparison group (n=13), there were no significant differences in asthma self-management, MDI skill, or asthma severity after the interventions. Findings supported the feasibility of implementing the combined intervention, and it was not inferior to the single intervention-which supports nurses' efforts to help families manage multiple health problems.

Effectiveness of self-management support interventions for people with comorbid diabetes and chronic kidney disease: a systematic review and meta-analysis

BackgroundSelf-management support interventions may potentially delay kidney function decline and associated complications in patients with comorbid diabetes and chronic kidney disease. However, the effectiveness of these interventions remains unclear. We investigated the effectiveness of current self-management support interventions and their specific components and elements in improving patient outcomes.MethodsElectronic databases were systematically searched from January 1, 1994, to December 19, 2017. Eligible studies were randomized controlled trials on self-management support interventions for adults with comorbid diabetes and chronic kidney disease. Primary outcomes were systolic blood pressure, diastolic blood pressure, estimated glomerular filtration rate, and glycated hemoglobin. Secondary outcomes included self-management activity, health service utilization, health-related quality of life, medication adherence, and death.ResultsOf the 48 trials identified, eight studies (835 patients) were eligible. There was moderate-quality evidence that self-management support interventions improved self-management activity (standard mean difference 0.56, 95% CI 0.15 to 0.97, p < 0.007) compared to usual care. There was low-quality evidence that self-management support interventions reduced systolic blood pressure (mean difference − 4.26 mmHg, 95% CI − 7.81 to − 0.70, p = 0.02) and glycated hemoglobin (mean difference − 0.5%, 95% CI − 0.8 to − 0.1, p = 0.01) compared to usual care.ConclusionsSelf-management support interventions may improve self-care activities, systolic blood pressure, and glycated hemoglobin in patients with comorbid diabetes and chronic kidney disease. It was not possible to determine which self-management components and elements were more effective, but interventions that utilized provider reminders, patient education, and goal setting were associated with improved outcomes. More evidence from high-quality studies is required to support future self-management programs.Systematic review registrationPROSPERO CRD42015017316.

An intervention to support stroke survivors and their carers in the longer term (LoTS2Care): study protocol for a cluster randomised controlled feasibility trial

BackgroundDespite the evidence that many stroke survivors report longer term unmet needs, the provision of longer term care is limited. To address this, we are conducting a programme of research to develop an evidence-based and replicable longer term care strategy. The developed complex intervention (named New Start), which includes needs identification, exploration of social networks and components of problem solving and self-management, was designed to improve quality of life by addressing unmet needs and increasing participation.Methods/DesignA multicentre, cluster randomised controlled feasibility trial designed to inform the design of a possible future definitive cluster randomised controlled trial (cRCT) and explore the potential clinical and cost-effectiveness of New Start.Ten stroke services across the UK will be randomised on a 1:1 basis either to implement New Start or continue with usual care only. New Start will be delivered by trained facilitators and will be offered to all stroke survivors within the services allocated to the intervention arm. Stroke survivors will be eligible for the trial if they are 4–6 months post-stroke and residing in the community. Carers (if available) will also be invited to take part. Invitation to participate will be initiated by post and outcome measures will be collected via postal questionnaires at 3, 6 and 9 months after recruitment. Outcome data relating to perceived health and disability, wellbeing and quality of life as well as unmet needs will be collected. A ‘study within a trial’ (SWAT) is planned to determine the most acceptable format in which to provide the postal questionnaires. Details of health and social care service usage will also be collected to inform the economic evaluation. The feasibility of recruiting services and stroke survivors to the trial and of collecting postal outcomes will be assessed and the potential for effectiveness will be investigated. An embedded process evaluation (reported separately) will assess implementation fidelity and explore and clarify causal assumptions regarding implementation.DiscussionThis feasibility trial with embedded process evaluation will allow us to gather important and detailed data regarding methodological and implementation issues to inform the design of a possible future definitive cRCT of this complex intervention.Trial RegistrationISRCTN38920246. Registered 22 June 2016.

Efficacy of a Community-Based Technology-Enabled Physical Activity Counseling Program for People With Knee Osteoarthritis: Proof-of-Concept Study

BackgroundCurrent practice guidelines emphasize the use of physical activity as the first-line treatment of knee osteoarthritis; however, up to 90% of people with osteoarthritis are inactive.ObjectiveWe aimed to assess the efficacy of a technology-enabled counseling intervention for improving physical activity in people with either a physician-confirmed diagnosis of knee osteoarthritis or having passed two validated criteria for early osteoarthritis.MethodsWe conducted a proof-of-concept randomized controlled trial. The immediate group received a brief education session by a physical therapist, a Fitbit Flex, and four biweekly phone calls for activity counseling. The delayed group received the same intervention 2 months later. Participants were assessed at baseline (T0) and at the end of 2 months (T1), 4 months (T2), and 6 months (T3). Outcomes included (1) mean time on moderate-to-vigorous physical activity (MVPA ≥3 metabolic equivalents [METs], primary outcome), (2) mean time on MVPA ≥4 METs, (3) mean daily steps, (4) mean time on sedentary activities, (5) Knee Injury and Osteoarthritis Outcome Score (KOOS), and (6) Partners in Health scale. Mixed-effects repeated measures analysis of variance was used to assess five planned contrasts of changes in outcome measures over measurement periods. The five contrasts were (1) immediate T1-T0 vs delayed T1-T0, (2) delayed T2-T1 vs delayed T1-T0, (3) mean of contrast 1 and contrast 2, (4) immediate T1-T0 vs delayed T2-T1, and (5) mean of immediate T2-T1 and delayed T3-T2. The first three contrasts estimate the between-group effects. The latter two contrasts estimate the effect of the 2-month intervention delay on outcomes.ResultsWe recruited 61 participants (immediate: n=30; delayed: n=31). Both groups were similar in age (immediate: mean 61.3, SD 9.4 years; delayed: mean 62.1, SD 8.5 years) and body mass index (immediate: mean 29.2, SD 5.5 kg/m2; delayed: mean 29.2, SD 4.8 kg/m2). Contrast analyses revealed significant between-group effects in MVPA ≥3 METs (contrast 1 coefficient: 26.6, 95% CI 4.0-49.1, P=.02; contrast 3 coefficient: 26.0, 95% CI 3.1-49.0, P=.03), daily steps (contrast 1 coefficient: 1699.2, 95% CI 349.0-3049.4, P=.02; contrast 2 coefficient: 1601.8, 95% CI 38.7-3164.9, P=.045; contrast 3 coefficient: 1650.5, 95% CI 332.3-2968.7; P=.02), KOOS activity of daily living subscale (contrast 1 coefficient: 6.9, 95% CI 0.1-13.7, P=.047; contrast 3 coefficient: 7.2, 95% CI 0.8-13.6, P=.03), and KOOS quality of life subscale (contrast 1 coefficient: 7.4, 95% CI 0.0-14.7, P=.049; contrast 3 coefficient: 7.3, 95% CI 0.1-14.6, P=.048). We found no significant effect in any outcome measures due to the 2-month delay of the intervention.ConclusionsOur counseling program improved MVPA ≥3 METs, daily steps, activity of daily living, and quality of life in people with knee osteoarthritis. These findings are important because an active lifestyle is an important component of successful self-management.Trial RegistrationClinicalTrials.gov NCT02315664; https://clinicaltrials.gov/ct2/show/NCT02315664 (Archived by WebCite at http://www.webcitation.org/6ynSgUyUC)

The Effect of Teach-Back Training on Self Management in Kidney Transplant Recipients: A Clinical Trial.

Kidney transplant recipients need self-management during their lifetime, and training these patients is essential for the realization of self-management. Teach-back training (TBT) was used to receive, understand, and retain information. This study aimed to determine the effect of TBT on self-management in kidney transplant recipients. In this clinical trial study, 84 kidney transplant recipients who referred to the clinic of Imam Khomeini Hospital in Urmia (a city in northwest of Iran), from January to March 2017, were selected through convenience sampling and randomly assigned to intervention and control groups. In the intervention group, educational content was presented for each patient with TBT in 5 sessions of 60 minutes. Data were collected before and after the intervention by a special Self-Management Questionnaire for Kidney Transplant Recipients in five areas as follows: self-monitoring, self-care behavior in daily living, early detecting and coping with abnormalities after kidney transplantation, stress management and the category of non-categorized area. This is a valid and reliable questionnaire (α=0.76). Collected data were analyzed by independent t-test and Mann-Whitney test. Statistical analysis was performed using SPSS 20 and P≤0.05 was considered as significant. Independent t-test showed that the mean of self-management score between the control and intervention groups was not statistically significant before the intervention (P=0.90). The mean score of self-management increased after implementation of TBT in the intervention group compared to the control group, and the difference was statistically significant (P=0.001). The implementation of TBT method is effective in promoting self-management of kidney transplant recipients. Therefore, it is recommended that this method should be used to train the patients to better understand the components of self-management. Trial Registration Number: IRCT2016122817059N10.