Self-management Intervention for Reducing Epilepsy Burden Among Adult Ugandans With Epilepsy (Smart-u), Randomised Clinical Trial Protocol
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PROVIDER: S-EPMC10705707 | biostudies-literature | 2023 Dec
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Project description:IntroductionStroke 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.MethodsA 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.DiscussionThe curriculum-guided self-management TargetEd MAnageMent Intervention (TEAM) program is anticipated to reduce the stroke burden in Uganda.Trial registrationClinicalTrials.gov identifier: NCT04685408, registered on 28 December 2020.
| S-EPMC8219138 | biostudies-literature
Project description:Managing one's own symptoms, medications, treatments, lifestyle, and psychological and social aspects of chronic disease is known as self-management. The Institute of Medicine has identified three categories of epilepsy self-management, including medication management, behavior management, and emotional support. Overall, there has been limited research of interventions measuring epilepsy self-management behaviors. The present study aimed to develop an abbreviated version of the full, previously published, Adult Epilepsy Self-Management Measurement Instrument (AESMMI) using confirmatory factor analysis. Data come from a cross-sectional survey of people with epilepsy. The sample included adults with epilepsy (n = 422), who reported that a clinician diagnosed them with epilepsy or a seizure disorder. We ran confirmatory factor analyses in testing the abbreviated scale. The scale was reduced using a theory-driven data-informed approach. The full AESMMI length was reduced by 40% (from 65 to 38 items) with an overall internal consistency of 0.912. The abbreviated AESMMI retained the 11 subdomains, with Cronbach's alphas from 0.535 to 0.878. This reduced item scale can be useful for assessing self-management behaviors for people with epilepsy or measuring outcomes in self-management research.
| S-EPMC10903544 | biostudies-literature
Project description:BackgroundSelf-care behavior is important in avoiding hospitalization for patients with heart failure (HF) and refers to those activities performed with the intention of improving or restoring health and well-being, as well as treating or preventing disease. The purpose was to study the effects of a home-based mobile device on self-care behavior and hospitalizations in a representative HF-population.Methods and resultsSMART-HF is a randomized controlled multicenter clinical trial, where patients were randomized 1:1 to receive standard care (control group [CG]) or intervention with a home-based tool designed to enhance self-care behavior (intervention group [IG]) and followed for 240 days. The tool educates the patient about HF, monitors objective and subjective symptoms and adjusts loop diuretics. The primary outcome is self-care as measured by the European Heart Failure Self-care behavior scale and the secondary outcome is HF related in-hospital days.A total of 124 patients were recruited and 118 were included in the analyses (CG: n = 60, IG: n = 58). The mean age was 79 years, 39% were female, and 45% had an ejection fraction of less than 40%. Self-care was significantly improved in the IG compared to the CG (median (interquartile range) (21.5 [13.25; 28] vs 26 [18; 29.75], p = 0.014). Patients in the IG spent significantly less time in the hospital admitted for HF (2.2 days less, relative risk 0.48, 95% confidence interval 0.32-0.74, P = .001).ConclusionsThe device significantly improved self-care behavior and reduced in-hospital days in a relevant HF population.
| S-EPMC7612444 | biostudies-literature
Project description:To evaluate the feasibility of a phase 3 randomised controlled trial (RCT) of a website (Living Well with Asthma) to support self-management.Phase 2, parallel group, RCT, participants recruited from 20 general practices across Glasgow, UK. Randomisation through automated voice response, after baseline data collection, to website access for minimum 12 weeks or usual care.Adults (age≥16 years) with physician diagnosed, symptomatic asthma (Asthma Control Questionnaire (ACQ) score ≥1). People with unstable asthma or other lung disease were excluded.'Living Well with Asthma' is a desktop/laptop compatible interactive website designed with input from asthma/ behaviour change specialists, and adults with asthma. It aims to support optimal medication management, promote use of action plans, encourage attendance at asthma reviews and increase physical activity.Primary outcomes were recruitment/retention, website use, ACQ and mini-Asthma Quality of Life Questionnaire (AQLQ). Secondary outcomes included patient activation, prescribing, adherence, spirometry, lung inflammation and health service contacts after 12 weeks. Blinding postrandomisation was not possible.Recruitment target met. 51 participants randomised (25 intervention group). Age range 16-78 years; 75% female; 28% from most deprived quintile. 45/51 (88%; 20 intervention group) followed up. 19 (76% of the intervention group) used the website, for a mean of 18 min (range 0-49). 17 went beyond the 2 'core' modules. Median number of logins was 1 (IQR 1-2, range 0-7). No significant difference in the prespecified primary efficacy measures of ACQ scores (-0.36; 95% CI -0.96 to 0.23; p=0.225), and mini-AQLQ scores (0.38; -0.13 to 0.89; p=0.136). No adverse events.Recruitment and retention confirmed feasibility; trends to improved outcomes suggest use of Living Well with Asthma may improve self-management in adults with asthma and merits further development followed by investigation in a phase 3 trial.ISRCTN78556552; Results.
| S-EPMC4874112 | biostudies-other
Project description:Epilepsy, a complex spectrum of disorders, affects about 2.9 million people in the U.S. Similar to other chronic disorders, people with epilepsy face challenges related to management of the disorder, its treatment, co-occurring depression, disability, social disadvantages, and stigma. Two national conferences on public health and epilepsy (1997, 2003) and a 2012 IOM report on the public health dimensions of epilepsy highlighted important knowledge gaps and emphasized the need for evidence-based, scalable epilepsy self-management programs. The Centers for Disease Control and Prevention translated recommendations on self-management research and dissemination into an applied research program through the Prevention Research Centers Managing Epilepsy Well (MEW) Network. MEW Network objectives are to advance epilepsy self-management research by developing effective interventions that can be broadly disseminated for use in people's homes, healthcare providers' offices, or in community settings. The aim of this report is to provide an update on the MEW Network research pipeline, which spans efficacy, effectiveness, and dissemination. Many of the interventions use e-health strategies to eliminate barriers to care (e.g., lack of transportation, functional limitations, and stigma). Strengths of this mature research network are the culture of collaboration, community-based partnerships, e-health methods, and its portfolio of prevention activities, which range from efficacy studies engaging hard-to-reach groups, to initiatives focused on provider training and knowledge translation. The MEW Network works with organizations across the country to expand its capacity, help leverage funding and other resources, and enhance the development, dissemination, and sustainability of MEW Network programs and tools. Guided by national initiatives targeting chronic disease or epilepsy burden since 2007, the MEW Network has been responsible for more than 43 scientific journal articles, two study reports, seven book chapters, and 62 presentations and posters. To date, two programs have been adopted and disseminated by the national Epilepsy Foundation, state Epilepsy Foundation affiliates, and other stakeholders. Recent expansion of the MEW Network membership will help to extend future reach and public health impact.
| S-EPMC6267934 | biostudies-literature
Project description:PurposeCancer survivors can experience symptoms such as fatigue, pain and distress that persist for many months following treatment. These enduring symptoms often impact on participation in self-care activities, returning to school and/or work, and leisure and social activities. Self-management support is increasingly recognised as a core aspect of cancer survivorship care to reduce the impact of persistent symptoms. The purpose of this study was to examine the feasibility and potential effectiveness of a group-based self-management intervention, OptiMal, to improve the physical and psychological health of cancer survivors. OptiMal is a six-week intervention comprising weekly sessions on fatigue, stress and physical activity, diet and effective communication strategies.MethodsA feasibility randomised control trial was undertaken. Individuals up to two years after cancer treatment were randomised to OptiMal or usual care. Feasibility was examined through recruitment and retention metrics. Potential effectiveness was tested through patient-reported outcomes collected at baseline and three months post-intervention. Descriptive and inferential statistics were used to analyse study data.ResultsRecruitment for this study was 32.5% (80/246 eligible individuals) with 77.5% retention at three-month follow-up (82.5% for intervention group and 72.5% for control group). Of those who attended the intervention, 19 (73%) attended all OptiMal sessions, indicating high adherence to the intervention. The majority of participants had breast cancer and were between 12 and 24 months post-treatment. The intervention group (n = 29) had statistically significant greater improvements in anxiety (p = 0.04) and health-related quality of life (health index score: p = 0.023, visual analogue score: p = 0.035) at three months post-intervention than the control group.ConclusionsRecruitment and retention in this study was similar to other cancer trials and the high adherence rate indicates that OptiMal is an acceptable self-management intervention for cancer survivors and warrants further investigation. OptiMal is intended to address symptoms reported across different cancer types. However, a limitation of this study was that the majority of participants had breast cancer, and therefore, generalisability of findings cannot be assumed for other cancer types. Future studies of OptiMal therefore need to use different strategies to recruit survivors of other cancer types.
| S-EPMC10742444 | biostudies-literature
Project description:Improving exercise capacity is a primary objective in COPD. Declines in exercise capacity result in reduced physical activity and health-related quality of life (HRQoL). Self-management interventions can teach patients skills and behaviours to manage their disease. Technology-mediated interventions have the potential to provide easily accessible support for disease self-management. We evaluated the effectiveness of a web-based self-management intervention, focused on physical activity promotion, on exercise capacity in COPD. This 6-month randomised controlled trial (NCT02099799) enrolled 153 persons with COPD at two US sites (VABoston, n=108; VABirmingham, n=45). Participants were allocated (1:1) to the web-based self-management intervention (physical activity promotion through personalised, progressive step-count goals, feedback, online COPD-related education and social support via an online community) or usual care. The primary outcome was exercise capacity (6-min walk distance (6 MWD)). Secondary outcomes included physical activity (daily steps per day), HRQoL (St. George's Respiratory Questionnaire Total Score), dyspnoea, COPD-related knowledge and social support. Change in step-count goals reflected intervention engagement. Participants' mean age was 69 (sd=7), and mean forced expiratory volume in 1 s % predicted was 61% (sd=21%). Change in 6MWD did not differ between groups. Intervention participants improved their mean daily step counts by 1312 more than those in the usual care group (p<0.001). Groups did not differ on other secondary outcomes. VABirmingham participants were significantly more engaged with the intervention, although site did not modify the effect of the intervention on 6MWD or secondary outcomes. The intervention did not improve exercise capacity but improved physical activity at 6 months. Additional intervention modifications are needed to optimise its COPD self-management capabilities.
| S-EPMC8405869 | biostudies-literature
Project description:BackgroundSelf-Management Support (SMS), refers to the actions taken by individuals to recognise and manage their own health. It is increasingly recognised that individuals with chronic obstructive pulmonary disease (COPD) require additional support with their Self-management. Emerging evidence suggests that the use of a social network intervention can improve health outcomes and increase quality of life. In order to understand the potential benefits of SMS in COPD, the GENIE (Generating Engagement in Network Support) SMS tool was implemented and evaluated in a COPD primary care context. The GENIE intervention is a social networking tool that consists of 3 parts; a concentric circle modelling to map existing social networks; a questions sections to elicit preferences for activities; a map of selected resources is then produced, aligned with the user's interests and suggestions for connections to existing network members and to new resources.MethodsA pilot, parallel, single blind, block randomised controlled trial. Patients with COPD ranging from mild-very severe were recruited. Participants provided written consent and were then randomised to either the intervention or usual care. The primary aim was to understand the clinical benefit through the analysis of health status, symptom burden and quality of life. The secondary outcome measure was health utilisation. NHS cost differences were reported between groups using the GENIE intervention over usual care.ResultsThe GENIE pilot results demonstrate maintenance in health status and clinical symptoms with a decrease in anxiety. An overall increase in quality of life was observed, these findings did not reach significance. A cost reduction was demonstrated in inpatient stay with no difference in primary care costs. Overall a cost reduction in NHS service utilisation was indicated in the intervention group.ConclusionThis pilot study indicated that using a social network intervention can encourage the development of new social connections and extend existing support networks for COPD patients. Increasing network support in this population is of benefit to both patients and NHS providers in terms of cost reductions and enhancing wellbeing. This broadens the understanding of possible new approaches to SMS in community COPD patients, which could now be investigated in a larger population over a longer period.Trial registrationClinical Trials.gov PRS National Library of Medicine. Protocol ID number: 19175, Clinical Trial ID: NCT02935452.
| S-EPMC7278059 | biostudies-literature
Project description:Background: Patient self-management plans (PSMP) are advised for bronchiectasis but their efficacy is not established. We aimed to determine whether, in people with bronchiectasis, the use of our bronchiectasis PSMP – Bronchiectasis Empowerment Tool (BET), compared to standard care, would improve self-efficacy. Methods: In a multi-centre mixed-methods randomised controlled parallel study, 220 patients with bronchiectasis were randomised to receive standard care with or without the addition of our BET plus education sessions explaining its use. BET comprised an action plan, indicating when to seek medical help based on pictorial represented indications for antibiotic therapy, and four educational support sections. At baseline and after 12 months, patients completed the Self-Efficacy to Manage Chronic Disease Scale (SEMCD), St George’s Respiratory Questionnaire (SGRQ), EQ-5D-3 L (to calculate Quality Adjusted Life Years (QALYs) and cost questionnaires. Qualitative data were obtained by focus groups. Results: The recruitment to the study was high (63% of eligible patients agreeing to participate) however completion rate was low (57%). BET had no effect on SEMCD (mean difference (0.14 (95% confidence interval (95%CI) ?0.37 to 0.64), p = 0.59) or SGRQ, exacerbation rates, overall cost to the NHS or QALYs. Most had developed their own techniques for monitoring their condition and they did not find BET useful as it was difficult to complete. Participant knowledge was good in both groups. Conclusion: The demand for patient support in bronchiectasis was high suggesting a clinical need. However, the BET did not improve self-efficacy, health related quality of life, costs or clinically relevant outcome measures. BET needs to be modified to be less onerous for users and implemented within a wider package of care. Further studies, particularly those evaluating people newly diagnosed with bronchiectasis, are required and should allow for 50% withdrawal rate or utilise less burdensome outcome measures. Clinical trials registration: ISRCTN ISRCTN 18400127. Registered 24 June 2015. Retrospectively Registered
| S-EPMC7716069 | biostudies-literature
Project description:Sedentary behaviours continue to increase and are associated with heightened risks of morbidity and mortality. We assessed the cost-effectiveness of SMART Work & Life (SWAL), an intervention designed to reduce sitting time inside and outside of work, both with (SWAL-desk) and without (SWAL-only) a height-adjustable workstation compared to usual practice (control) for UK office workers. Health outcomes were assessed in quality-adjusted life-years (QALY) and costs in pound sterling (2019-2020). Discounted costs and QALYs were estimated using regression methods with multiply imputed data from the SMART Work & Life trial. Absenteeism, productivity and wellbeing measures were also evaluated. The average cost of SWAL-desk was £228.31 and SWAL-only £80.59 per office worker. Within the trial, SWAL-only was more effective and costly compared to control (incremental cost-effectiveness ratio (ICER): £12,091 per QALY) while SWAL-desk was dominated (least effective and most costly). However, over a lifetime horizon, both SWAL-only and SWAL-desk were more effective and more costly than control. Comparing SWAL-only to control generated an ICER of £4985 per QALY. SWAL-desk was more effective and costly than SWAL-only, generating an ICER of £13,378 per QALY. Findings were sensitive to various worker, intervention, and extrapolation-related factors. Based on a lifetime horizon, SWAL interventions appear cost-effective for office-workers conditional on worker characteristics, intervention cost and longer-term maintenance in sitting time reductions.
| S-EPMC9690649 | biostudies-literature