Reducing stroke burden through a targeted self-management intervention for reducing stroke risk factors in high-risk Ugandans: A protocol for a randomized controlled trial.
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ABSTRACT: Introduction
Stroke burden is rapidly increasing globally. Modifiable risk factors offer an opportunity to intervene, and targeting hypertension is a key actionable target for stroke risk reduction in sub-Saharan Africa. This 3-site planned randomized controlled trial builds on promising preliminary data.Methods
A total of 246 Ugandan adults will be recruited randomized to experimental intervention vs. enhanced treatment control. Intervention participants will receive six weekly group-format stroke risk reduction self-management training sessions, and the controls will receive information on cardiovascular risk. The primary study outcome is systolic B.P. measured at baseline, 13-week, 24 weeks (6 months). Secondary outcomes include other biological and behavioral stroke risk factors.Discussion
The curriculum-guided self-management TargetEd MAnageMent Intervention (TEAM) program is anticipated to reduce the stroke burden in Uganda.Trial registration
ClinicalTrials.gov identifier: NCT04685408, registered on 28 December 2020.
SUBMITTER: Kaddumukasa M
PROVIDER: S-EPMC8219138 | biostudies-literature | 2021
REPOSITORIES: biostudies-literature
Publications
Reducing stroke burden through a targeted self-management intervention for reducing stroke risk factors in high-risk Ugandans: A protocol for a randomized controlled trial.
Kaddumukasa Mark M Najjuma Josephine J Mbalinda Scovia Nalugo SN Kaddumukasa Martin N MN Nakibuuka Jane J Burant Christopher C Moore Shirley S Blixen Carol C Katabira Elly T ET Sajatovic Martha M
PloS one 20210622 6
<h4>Introduction</h4>Stroke burden is rapidly increasing globally. Modifiable risk factors offer an opportunity to intervene, and targeting hypertension is a key actionable target for stroke risk reduction in sub-Saharan Africa. This 3-site planned randomized controlled trial builds on promising preliminary data.<h4>Methods</h4>A total of 246 Ugandan adults will be recruited randomized to experimental intervention vs. enhanced treatment control. Intervention participants will receive six weekly ...[more]
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Project description:IntroductionStroke remains a global concern due to increasing lifespan, patterns of industrialization, adoption of harmful western diets, and an increasing prevalence of risk factors such as hypertension, obesity, and diabetes. We investigated an adopted novel self-management intervention, TargetEd mAnageMent Intervention (TEAM) to reduce modifiable stroke risk factors in Uganda.MethodsA six-month, uncontrolled, prospective pilot study to establish feasibility, acceptability and preliminary efficacy of TEAM in Ugandans at high risk for stroke was conducted. The primary outcome was change in systolic BP from baseline to 24-week follow-up. Secondary outcomes included change in diastolic BP, serum cholesterol, high and low density lipoprotein (HDL, LDL) and triglycerides.ResultsMean (SD) baseline systolic BP was 162.9 (±25.6) mmHg while mean (SD) baseline diastolic BP was 99.1 (±13.8) mmHg. There was a significant reduction in mean baseline blood pressure of 163/98.8mmHg to blood pressure of 147.8/88.0mmHg at 24weeks, P=0.023. There were also significant reductions in the serum total cholesterol levels at 24weeks with P=0.001.ConclusionTargeted training in self-management (TEAM) adapted to the Ugandan setting is feasible, highly acceptable to participants and appears to be associated with reduced blood pressure, improved lipid profiles and improved glucose control in diabetics.
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Project description:ObjectiveTo investigate whether the self-management intervention was implemented as intended. Additionally, we studied involvement in and satisfaction with the intervention among patients, their partners and therapists.DesignMixed method, prospective study.SettingOutpatient facilities of hospitals/rehabilitation centres.ParticipantsStroke patients, their partners and therapists from the experimental arm of the Restore4Stroke Self-Management study.Intervention'Plan Ahead!' is a 10-week self-management intervention for stroke patients and partners, consisting of seven two-hour group sessions. Proactive action planning, education and peer support are main elements of this intervention.Main measuresSession logs, questionnaires for therapists, patients and their partners, and focus groups.Data analysisQualitative data were analysed with thematic analysis supplemented by quasi-statistics. Quantitative data were reported as descriptive statistics.ResultsThe study sample consisted of 53 patients and 26 partners taking part in the intervention, and all therapists delivering the intervention (N = 19). At least three-quarters of the intervention sessions were attended by 33 patients and 24 partners. On a scale from 1 to 10, patients, partners and therapists rated the intervention with mean scores of 7.5 (SD1.6), 7.8 (SD.7) and 7.4 (SD.7), respectively. Peer support was the most frequently appreciated element for participants and therapists. The proactive action planning tool was adequately applied in 76 of the 96 sessions.ConclusionAlthough the target audience was reached and both participants and therapists were satisfied with the intervention, the proactive action planning tool that distinguishes the current intervention from existing stroke-specific self-management interventions was only partly implemented according to protocol.
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Project description:BackgroundLife after stroke can be an ongoing struggle with over half of all survivors reporting unmet emotional and social needs. In the United Kingdom's (UK) national clinical guidelines for stroke, self-management is suggested as one approach which can support long-term needs. In the UK NHS, self-management interventions are delivered in various ways. Regardless of the delivery mechanism, a tailored approach and ways to integrate peer support are advocated. Group delivery offers a platform for peer support and has the potential to remain individualised. However, before the efficacy of a group self-management intervention can be tested, the feasibility must be explored. This research investigates the feasibility of a GroUp Self-management intervention for sTrOke (GUSTO).MethodsA randomised waitlist control design will be used to investigate the feasibility of a group self-management intervention adapted from an existing one-to-one intervention called Bridges. A mixed methods approach will be used. Qualitative work will capture participant experience, while quantitative work will allow preliminary comparison between the intervention and waitlist groups (between subjects) and pre-post intervention measures (within subjects). Interviews will be conducted with stroke survivors and focus groups with family and friends to assess acceptability of the intervention.DiscussionThere is a growing interest in group-based self-management interventions for stroke as a method of supporting stroke survivors' ongoing unmet needs. This is an area with limited research to date. This study will inform design of a fully powered trial which would assess the efficacy of a group self-management intervention following stroke.Trial registrationISRCTN19867168.
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Project description:BackgroundThere is a growing evidence base to support the use of self-management interventions for improving quality of life after stroke. However, stroke survivors with aphasia have been underrepresented in research to date. It is therefore unclear if self-management is an appropriate or effective approach for this group. To address this gap in the evidence base, we have developed a supported self-management intervention (the 'Living with Aphasia' intervention) specifically for stroke survivors with aphasia in the first year after stroke. The StarStep study aims to assess the feasibility of implementing and evaluating the intervention (including the feasibility of participant recruitment, the feasibility of delivering facilitator training, the acceptability of the intervention, the fidelity of intervention delivery and outcome data completeness).MethodsStarStep is a mixed-methods, non-randomised feasibility study. The Living with Aphasia intervention will be facilitated by speech and language therapists and implemented in two community stroke teams in the north of England. We aim to recruit 30 stroke survivors who have aphasia (and/or their family members) and who are ≤ 12-month post-stroke to participate in data collection for the study. Following informed consent, participants will complete a baseline data collection questionnaire which will include measures of quality of life, symptoms of depression and perceived communicative effectiveness. Follow-up questionnaires will be completed at 3-month post-intervention. Qualitative data collection will include implementation groups and semi-structured interviews with speech and language therapists, semi-structured interviews with stroke survivors with aphasia (and/or their family members) and observations of the delivery of the intervention. A joint display table will be used to integrate findings from each element of data collection in order to consider overall feasibility.DiscussionThis study will provide the information necessary to optimise data collection processes and to optimise the implementation and delivery of the self-management intervention. Feasibility data will inform decision-making regarding progression to a future definitive cluster randomised controlled trial to evaluate the effectiveness of the intervention.Trial registrationISRCTN registry, trial registration number: ISRCTN10401966. Date of registration: 07/10/2023. URL of trial registry record: https://doi.org/10.1186/ISRCTN10401966 .
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Project description:BackgroundSelf-management programs are recognized as a valuable approach to supporting people with long-term conditions, such as stroke, in managing their daily lives. Bridges Self-Management (Bridges) focuses on how practitioners interact and support patients' confidence, skills, and knowledge, and it is an example of a complex intervention. Bridges has been developed and used across multiple health care pathways in the United Kingdom and is theoretically informed by social cognition theory and self-efficacy principles. Evidence shows that self-management programs based on the construct of self-efficacy can be effective. There is still much to learn about how health care services or pathways should implement support for self-management in a sustainable way and whether this implementation process is different depending on the context or culture of the team or service provided.ObjectiveThe aim of this study is to tailor and evaluate an intervention (Bridges) to support self-management after stroke in a Swedish context.MethodsWe will use a pretest-posttest design with a case study approach to evaluate the feasibility and implementation of self-management support in two stroke settings. This project includes a complex intervention and depends on the actions of individuals, different contexts, and the adaptation of behavior over time. A mixed methods approach was chosen to understand both outcomes and mechanisms of impact. Data collection will comprise outcome measurements and assessment tools as well as qualitative interviews. Data will be collected concurrently and integrated into a mixed methods design.ResultsRecruitment and data collection for the first site of the project ran from September 1, 2021, to January 17, 2022. The intervention at the first site was conducted from November 1, 2021, to March 5, 2022. The evaluation will start after the implementation phase. The second site has been recruited, and the baseline data collection will start in spring 2022. The intervention will start in early autumn 2022. Data collection will be completed by the end of 2022.ConclusionsThis study represents a unique, highly relevant, and innovative opportunity to maximize knowledge and minimize practice gaps in rehabilitation stroke care. The study will produce robust data on the intervention and in-depth data on the contextual factors and mechanisms related to the feasibility of the intervention and for whom it is feasible. Bridges has been used in the United Kingdom for more than 10 years, and this study will explore its contextualization and implementation within a Swedish stroke environment. The evaluation will study results at the patient, staff, and organizational levels and provide recommendations for the adoption and refinement of future efforts to support self-management.International registered report identifier (irrid)DERR1-10.2196/37672.
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Project description:BackgroundDigital 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.ObjectiveThis 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.MethodsWe 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.ResultsIn 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).ConclusionsWe 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.
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Project description:BackgroundDigital interventions provided through smartphones or the internet that are guided by a coach have been proposed as promising solutions to support the self-management of chronic conditions. However, digital intervention for poststroke self-management is limited; we developed the interactive Self-Management Augmented by Rehabilitation Technologies (iSMART) intervention to address this gap.ObjectiveThis study aimed to examine the feasibility and initial effects of the iSMART intervention to improve self-management self-efficacy in people with stroke.MethodsA parallel, 2-arm, nonblinded, randomized controlled trial of 12-week duration was conducted. A total of 24 participants with mild-to-moderate chronic stroke were randomized to receive either the iSMART intervention or a manual of stroke rehabilitation (attention control). iSMART was a coach-guided, technology-supported self-management intervention designed to support people managing chronic conditions and maintaining active participation in daily life after stroke. Feasibility measures included retention and engagement rates in the iSMART group. For both the iSMART intervention and active control groups, we used the Feasibility of Intervention Measure, Acceptability of Intervention Measure, and Intervention Appropriateness Measure to assess the feasibility, acceptability, and appropriateness, respectively. Health measures included the Participation Strategies Self-Efficacy Scale and the Patient-Reported Outcomes Measurement Information System's Self-Efficacy for Managing Chronic Conditions.ResultsThe retention rate was 82% (9/11), and the engagement (SMS text message response) rate was 78% for the iSMART group. Mean scores of the Feasibility of Intervention Measure, Acceptability of Intervention Measure, and Intervention Appropriateness Measure were 4.11 (SD 0.61), 4.44 (SD 0.73), and 4.36 (SD 0.70), respectively, which exceeded our benchmark (4 out of 5), suggesting high feasibility, acceptability, and appropriateness of iSMART. The iSMART group showed moderate-to-large effects in improving self-efficacy in managing emotions (r=0.494), symptoms (r=0.514), daily activities (r=0.593), and treatments and medications (r=0.870), but the control group showed negligible-to-small effects in decreasing self-efficacy in managing emotions (r=0.252), symptoms (r=0.262), daily activities (r=0.136), and treatments and medications (r=0.049). In addition, the iSMART group showed moderate-to-large effects of increasing the use of participation strategies for management in the home (r=0.554), work (r=0.633), community (r=0.673), and communication activities (r=0.476). In contrast, the control group showed small-to-large effects of decreasing the use of participation strategies for management in the home (r=0.567), work (r=0.342, community (r=0.215), and communication activities (r=0.379).ConclusionsOur findings support the idea that iSMART was feasible to improve poststroke self-management self-efficacy. Our results also support using a low-cost solution, such as SMS text messaging, to supplement traditional therapeutic patient education interventions. Further evaluation with a larger sample of participants is still needed.Trial registrationClinicalTrials.gov 202004137; https://clinicaltrials.gov/study/NCT04743037?id=202004137&rank=1.
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Project description:BACKGROUND:Systemic sclerosis (SSc), or scleroderma, is a rare disease that often results in significant disruptions to activities of daily living and can negatively affect physical and psychological well-being. Because there is no known cure, SSc treatment focuses on reducing symptoms and disability and improving health-related quality of life (HRQoL). Self-management programs are known to increase self-efficacy for disease management in many chronic diseases. The Scleroderma Patient-centered Intervention Network (SPIN) developed a Web-based self-management program (SPIN self-management; SPIN-SELF) to increase self-efficacy for disease management and to improve HRQoL for patients with SSc. OBJECTIVE:The proposed study aims to assess the feasibility of conducting a full-scale randomized controlled trial (RCT) of the SPIN-SELF program by evaluating the trial implementation processes, required resources and management, scientific aspects, and participant acceptability and usage of the SPIN-SELF program. METHODS:The SPIN-SELF feasibility trial will be conducted via the SPIN Cohort. The SPIN Cohort was developed as a framework for embedded pragmatic trials using the cohort multiple RCT design. In total, 40 English-speaking SPIN Cohort participants with low disease management self-efficacy (Self-Efficacy for Managing Chronic Disease Scale score ?7), who have indicated interest in using a Web-based self-management program, will be randomized with a 3:2 ratio into the SPIN-SELF program or usual care for 3 months. Feasibility outcomes include trial implementation processes, required resources and management, scientific aspects, and patient acceptability and usage of the SPIN-SELF program. RESULTS:Enrollment of the 40 participants occurred between July 5, 2019, and July 27, 2019. By November 25, 2019, data collection of trial outcomes was completed. Data analysis is underway, and results are expected to be published in 2020. CONCLUSIONS:The SPIN-SELF program is a self-help tool that may improve disease-management self-efficacy and improve HRQoL in patients with SSc. The SPIN-SELF feasibility trial will ensure that trial methodology is robust, feasible, and consistent with trial participant expectations. The results will guide adjustments that need to be implemented before undertaking a full-scale RCT of the SPIN-SELF program. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/16799.
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