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.
Ontology highlight
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 |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:INTRODUCTION:Stroke 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. METHODS:A 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. RESULTS:Mean (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. CONCLUSION:Targeted 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.
| S-EPMC5804990 | biostudies-literature
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.
| S-EPMC5131629 | biostudies-literature
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.
| S-EPMC5765599 | biostudies-literature
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.
| S-EPMC9123550 | biostudies-literature
Project description:BACKGROUND:Elderly people represent the majority of stroke cases worldwide. Post-stroke sequelae frequently lead to a more isolated life. Restricted social relations render older individuals with stroke a vulnerable group, especially in terms of social reintegration. Reintegration into the community after a stroke largely depends on support from the family. However, close relatives are at risk of becoming overburdened. The aim of this study is to investigate the effect of a novel self-management intervention to support elderly people after stroke. METHODS/DESIGN:Randomized controlled trial. Two weeks before discharge from a rehabilitation hospital/center, individuals with stroke aged > 65 years will be randomized either to a group receiving conventional neurorehabilitation (control) or to an additional novel self-management intervention. In the intervention group, patients with stroke will be offered eight self-management sessions of 45-60 min duration by a physiotherapist or an occupational therapist during a period of nine months after discharge. Inclusion will continue until at least 35 individuals in each group have been recruited. Study outcome measurements: Stroke Self-efficacy Questionnaire, a short version of Stroke Specific Quality of Life Scale, Impact on Participation and Autonomy and Caregiver Burden Scale. Furthermore, physical activity will be assessed using accelerometers. All outcomes except "impact on participation" and "autonomy" will be assessed at baseline, three months, and nine months after discharge. Impact on participation and autonomy will be assessed at three and nine months after discharge. Patient, informal caregiver, and therapist satisfaction will be examined by way of questionnaires and interviews. DISCUSSION:Self-management interventions are promising strategies for rehabilitation, potentially increasing self-efficacy, quality of life, as well as participation and autonomy. The introduction of a novel self-management intervention in combination with traditional physical and occupational therapy may enhance recovery after stroke and quality of life and lessen the burden on relatives. This trial "Stroke - 65 Plus. Continued Active Life," will provide further evidence of self-management strategies to clinicians, patients, and health economists. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03183960 . Registered on 12 June 2017.
| S-EPMC6245630 | biostudies-other
Project description:The heightened risk of persons with serious mental illness (SMI) to contract and transmit human immunodeficiency virus (HIV) is a public health problem. Our objective was test the effectiveness of a community-based advanced practice nurse intervention to promote adherence to HIV and psychiatric treatment regimens call Preventing AIDS Through Health for Positives (PATH+). We enrolled 238 HIV-positive subjects with SMI who were in treatment at community HIV provider agencies from 2004 to 2009. Participants in the intervention group were assigned an advanced practice nurse who provided community-based care management at a minimum of one visit/week and coordinated their medical and mental healthcare for 12 months. A parallel process latent growth curve model using three data points for biomarkers (baseline, 12 and 24 months) and five data points for health related quality of life (baseline, 3, 6, 12, and 24 months) showed moderate to excellent fit for modeling changes in CD4, viral load, and mental and physical SF-12 subscales. Results suggest that positive effects for PATH+ persisted at 24 months; 12 months after the intervention ended. This project demonstrates the effectiveness of a nurse-led, community-based, individually tailored adherence intervention. We demonstrated improved outcomes in individuals with HIV/SMI and regarding health-related quality of life and reductions in disease burden.
| S-EPMC3940688 | biostudies-literature
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.
| S-EPMC7210498 | biostudies-literature
Project description:Over 65% of stroke survivors are either overweight or obese and have multiple cardiovascular risk factors. However, few studies have examined the effects of comprehensive lifestyle behavior interventions to promote weight loss and control cardiovascular risk factors in stroke survivors. Thus, the purpose of this study is to examine a novel behavior change approach--SystemCHANGE™--to promote weight loss and improve health and function in stroke survivors. SystemCHANGE™ focuses on redesigning the social environment to achieve a specific goal.We will conduct a randomized controlled pilot study to examine the efficacy, feasibility, and safety of the SystemCHANGE™ weight management program in overweight and obese stroke survivors. The central hypothesis of the study is that the SystemCHANGE™ intervention will help overweight and obese stroke survivors lose 5% of their body weight, thereby improving health and function. Thirty-five stroke survivors will be randomized into either the 6-month SystemCHANGE™ intervention or a contact-control intervention. Outcome measures will be assessed at baseline and again at 3 and 6 months after the interventions. Body composition will be assessed using a Bod Pod. Patient-reported outcomes will be the Stroke Impact Scale and Reintegration to Normal Living Index. Objective outcomes will include the 6-Minute Walking Test and Rivermead Motor Assessment.This study will be the first randomized controlled trial to evaluate the efficacy and safety of a weight management intervention in stroke survivors using the SystemCHANGE™ approach. Furthermore, it will be the first empirically-examined comprehensive lifestyle intervention designed to target physical activity, nutrition, and sleep to promote weight loss in stroke survivors.ClinicalTrials.gov Identifier: NCT01776034.
| S-EPMC3663646 | biostudies-literature
Project description:IntroductionAsthma-related morbidity and mortality in the UK is higher than elsewhere in Europe. Although the reasons for this are largely unclear, one explanation could be a higher prevalence of poorly controlled asthma in the UK. Findings from our earlier study found that, in a sample of 766 children with asthma, 45.7% had poorly controlled asthma. Our earlier study also showed that adherence to inhaled corticosteroids was low. Subsequent focus groups identified concerns regarding embarrassment and bullying as barriers to adherence, as well as forgetfulness and incorrect medication beliefs. Following this, a school-based self-management intervention has been developed, aimed to improve asthma control and self-management behaviours.Methods and analysisThe theory-based cluster randomised controlled trial tests an intervention comprising two components: (1) a theatre workshop for all children in years 7 and 8, and (2) self-management workshops for children with asthma. The COM-B model was used to guide the development of the intervention. Questionnaire data will be collected in schools at baseline, immediately post intervention, and 3, 6 and 12 months post intervention. The data collected at 6?months will measure the effect of the intervention against the baseline data. The primary outcome will be asthma control, measured using the Asthma Control Test. All the data will be analysed quantitatively using generalised linear and non-linear mixed effects models.Ethics and disseminationEthical approval was obtained by the Queen Mary University of London Ethics Committee on 12 April 2018. Regular meetings will be held with key patient and public stakeholders to plan the key messages from this research. Key messages from the study will also be tweeted via the project twitter account (@SchoolsAsthma). The findings of the study will be submitted for presentation at conferences, as well as written into a manuscript.Trial registration numberMGU0400.
| S-EPMC6500249 | biostudies-literature
Project description:BACKGROUND:Stroke secondary prevention guidelines recommend medication prescription and adherence, active education and behavioural counselling regarding lifestyle risk factors. To impact on recurrent vascular events, positive behaviour/s must be adopted and sustained as a lifestyle choice, requiring theoretically informed behaviour change and self-management interventions. A growing number of systematic reviews have addressed complex interventions in stroke secondary prevention. Differing terminology, inclusion criteria and overlap of studies between reviews makes the mechanism/s that affect positive change difficult to identify or replicate clinically. Adopting a two-phase approach, this overview will firstly comprehensively summarise systematic reviews in this area and secondly identify and synthesise primary studies in these reviews which provide person-centred, theoretically informed interventions for stroke secondary prevention. METHODS:An overview of reviews will be conducted using a systematic search strategy across the Cochrane Database of Systematic Reviews, PubMed and Epistomonikas. INCLUSION CRITERIA:systematic reviews where the population comprises individuals post-stroke or TIA and where data relating to person-centred risk reduction are synthesised for evidence of efficacy when compared to standard care or no intervention. Primary outcomes of interest include mortality, recurrent stroke and other cardiovascular events. In phase 1, two reviewers will independently (1) assess the eligibility of identified reviews for inclusion; (2) rate the quality of included reviews using the ROBIS tool; (3) identify unique primary studies and overlap between reviews; (4) summarise the published evidence supporting person-centred behavioural change and self-management interventions in stroke secondary prevention and (5) identify evidence gaps in this field. In phase 2, two independent reviewers will (1) examine person-centred, primary studies in each review using the Template for Intervention Description and Replication (TIDieR checklist), itemising, where present, theoretical frameworks underpinning interventions; (2) group studies employing theoretically informed interventions by the intervention delivered and by the outcomes reported (3) apply GRADE quality of evidence for each intervention by outcome/s identified from theoretically informed primary studies. Disagreement between reviewers at each process stage will be discussed and a third reviewer consulted. DISCUSSION:This overview will comprehensively bring together the best available evidence supporting person-centred, stroke secondary prevention strategies in an accessible format, identifying current knowledge gaps.
| S-EPMC6292177 | biostudies-literature