An online intervention for improving stroke survivors' health-related quality of life: study protocol for a randomised controlled trial.
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ABSTRACT: Background
Recurrent stroke is a major contributor to stroke-related disability and costs. Improving health-risk behaviours and mental health has the potential to significantly improve recovery, enhance health-related quality of life (HRQoL), independent living, and lower the risk of recurrent stroke. The primary aim will be to test the effectiveness of an online intervention to improve HRQoL among stroke survivors at 6 months' follow-up. Programme effectiveness on four health behaviours, anxiety and depression, cost-effectiveness, and impact on other hospital admissions will also be assessed.Methods/design
An open-label randomised controlled trial is planned. A total of 530 adults will be recruited across one national and one regional stroke registry and block randomised to the intervention or minimal care control group. The intervention group will receive access to the online programme Prevent 2nd Stroke (P2S); the minimal care control group will receive an email with Internet addresses of generic health sites designed for the general population. The primary outcome, HRQoL, will be measured using the EuroQol-5D. A full analysis plan will compare between groups from baseline to follow-up.Discussion
A low-cost per user option to supplement current care, such as P2S, has the potential to increase HRQoL for stroke survivors, and reduce the risk of second stroke.Trial registration
Australian and New Zealand Clinical Trials Registry, ID: ACTRN12617001205325p . Registered on 17 August 2017.
SUBMITTER: Guillaumier A
PROVIDER: S-EPMC6688335 | biostudies-literature | 2019 Aug
REPOSITORIES: biostudies-literature
Publications
An online intervention for improving stroke survivors' health-related quality of life: study protocol for a randomised controlled trial.
Guillaumier Ashleigh A McCrabb Sam S Spratt Neil J NJ Pollack Michael M Baker Amanda L AL Magin Parker P Turner Alyna A Oldmeadow Christopher C Collins Clare C Callister Robin R Levi Chris C Searles Andrew A Deeming Simon S Wynne Olivia O Denham Alexandra M J AMJ Clancy Brigid B Bonevski Billie B
Trials 20190809 1
<h4>Background</h4>Recurrent stroke is a major contributor to stroke-related disability and costs. Improving health-risk behaviours and mental health has the potential to significantly improve recovery, enhance health-related quality of life (HRQoL), independent living, and lower the risk of recurrent stroke. The primary aim will be to test the effectiveness of an online intervention to improve HRQoL among stroke survivors at 6 months' follow-up. Programme effectiveness on four health behaviours ...[more]
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Project description:BackgroundThe aim of this trial was to evaluate the effectiveness of an online health behaviour change intervention-Prevent 2nd Stroke (P2S)-at improving health-related quality of life (HRQoL) amongst stroke survivors at 6 months of follow-up.Methods and findingsA prospective, blinded-endpoint randomised controlled trial, with stroke survivors as the unit of randomisation, was conducted between March 2018 and November 2019. Adult stroke survivors between 6 and 36 months post-stroke with capacity to use the intervention (determined by a score of ≥4 on the Modified Rankin Scale) and who had access and willingness to use the internet were recruited via mail-out invitations from 1 national and 1 regional stroke registry. Participants completed baseline (n = 399) and 6-month follow-up (n = 356; 89%) outcome assessments via computer-assisted telephone interviewing (CATI). At baseline the sample had an average age of 66 years (SD 12), and 65% were male. Randomisation occurred at the end of the baseline survey; CATI assessors and independent statisticians were blind to group allocation. The intervention group received remote access for a 12-week period to the online-only P2S program (n = 199; n = 28 lost at follow-up). The control group were emailed and posted a list of internet addresses of generic health websites (n = 200; n = 15 lost at follow-up). The primary outcome was HRQoL as measured by the EuroQol Visual Analogue Scale (EQ-VAS; self-rated global health); the outcome was assessed for differences between treatment groups at follow-up, adjusting for baseline measures. Secondary outcomes were HRQoL as measured by the EQ-5D (descriptive health state), diet quality, physical activity, alcohol consumption, smoking status, mood, physical functioning, and independent living. All outcomes included the variable 'stroke event (stroke/transient ischaemic attack/other)' as a covariate, and analysis was intention-to-treat. At 6 months, median EQ-VAS HRQoL score was significantly higher in the intervention group than the control group (85 vs 80, difference 5, 95% CI 0.79-9.21, p = 0.020). The results were robust to the assumption the data were missing at random; however, the results were not robust to the assumption that the difference in HRQoL between those with complete versus missing data was at least 3 points. Significantly higher proportions of people in the intervention group reported no problems with personal care (OR 2.17, 95% CI 1.05-4.48, p = 0.0359) and usual activities (OR 1.66, 95% CI 1.06-2.60, p = 0.0256) than in the control group. There were no significant differences between groups on all other secondary outcomes. The main limitation of the study is that the sample comprises mostly 'well' stroke survivors with limited to no disability.ConclusionsThe P2S online healthy lifestyle program improved stroke survivors' self-reported global ratings of HRQoL (as measured by EQ-VAS) at 6-month follow-up. Online platforms represent a promising tool to engage and support some stroke survivors.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12617001205325.
| S-EPMC9017949 | biostudies-literature
Project description:BackgroundAdherence to therapies is a primary determinant of treatment success, yet the World Health Organisation estimate that only 50% of patients who suffer from chronic diseases adhere to treatment recommendations. In a previous project, we found that 30% of stroke patients reported sub-optimal medication adherence, and this was associated with younger age, greater cognitive impairment, lower perceptions of medication benefits and higher specific concerns about medication. We now wish to pilot a brief intervention aimed at (a) helping patients establish a better medication-taking routine, and (b) eliciting and modifying any erroneous beliefs regarding their medication and their stroke.Methods/designThirty patients will be allocated to a brief intervention (2 sessions) and 30 to treatment as usual. The primary outcome will be adherence measured over 3 months using Medication Event Monitoring System (MEMS) pill containers which electronically record openings. Secondary outcomes will include self reported adherence and blood pressure.DiscussionThis study shall also assess uptake/attrition, feasibility, ease of understanding and acceptability of this complex intervention.Trial registrationCurrent Controlled Trials ISRCTN38274953.
| S-EPMC2838838 | biostudies-literature
Project description:INTRODUCTION:Low quality of life is common in cancer survivors. Increasing physical activity, improving diet, supporting psychological well-being and weight loss can improve quality of life in several cancers and may limit relapse. The aim of the randomised controlled trial outlined in this protocol is to examine whether a digital intervention (Renewed), with or without human support, can improve quality of life in cancer survivors. Renewed provides support for increasing physical activity, managing difficult emotions, eating a healthier diet and weight management. METHODS AND ANALYSIS:A randomised controlled trial is being conducted comparing usual care, access to Renewed or access to Renewed with brief human support. Cancer survivors who have had colorectal, breast or prostate cancer will be identified and invited through general practice searches and mail-outs. Participants are asked to complete baseline measures immediately after screening and will then be randomised to a study group; this is all completed on the Renewed website. The primary outcome is quality of life measured by the European Organization for Research and Treatment of Cancer QLQ-c30. Secondary outcomes include anxiety and depression, fear of cancer recurrence, general well-being, enablement and items relating to costs for a health economics analysis. Process measures include perceptions of human support, intervention usage and satisfaction, and adherence to behavioural changes. Qualitative process evaluations will be conducted with patients and healthcare staff providing support. ETHICS AND DISSEMINATION:The trial has been approved by the NHS Research Ethics Committee (Reference 18/NW/0013). The results of this trial will be published in peer-reviewed journals and through conference presentations. TRIAL REGISTRATION NUMBER:ISRCTN96374224; Pre-results.
| S-EPMC6429898 | biostudies-literature
Project description:IntroductionThe STRoke Interactive Virtual thErapy (STRIVE) intervention provides community-dwelling stroke survivors access to individualised, remotely supervised progressive exercise training via an online platform. This trial aims to determine the clinical efficacy of the STRIVE intervention and its effect on brain activity in community-dwelling stroke survivors.Methods and analysisIn a multisite, assessor-blinded randomised controlled trial, 60 stroke survivors >3 months poststroke with mild-to-moderate upper extremity impairment will be recruited and equally randomised by location (Melbourne, Victoria or Launceston, Tasmania) to receive 8 weeks of virtual therapy (VT) at a local exercise training facility or usual care. Participants allocated to VT will perform 3-5 upper limb exercises individualised to their impairment severity and preference, while participants allocated to usual care will be asked to maintain their usual daily activities. The primary outcome measures will be upper limb motor function and impairment, which will be assessed using the Action Research Arm Test and Upper Extremity Fugl-Meyer, respectively. Secondary outcome measures include upper extremity function and spasticity, as measured by the box and block test and Modified AshworthScale, respectively, and task-related changes in bilateral sensorimotor cortex haemodynamics during hand reaching and wrist extension movements as measured by functional near-infrared spectroscopy. Quality of life will be measured using the Euro-Quality of Life-5 Dimension-5 Level Scale, and the Motor Activity Log-28 will be used to measure use of the hemiparetic arm. All measures will be assessed at baseline and immediately postintervention.Ethics and disseminationThe study was approved by the Deakin University Human Research Ethics Committee in May 2017 (No. 2017-087). The results will be disseminated in peer-reviewed journals and presented at major international stroke meetings.Trial registration numberACTRN12617000745347; Pre-results.
| S-EPMC5781224 | biostudies-literature
Project description:IntroductionMany stroke survivors have unmet psychosocial needs during the recovery phase following a stroke. There is emerging evidence that peer support interventions may play a valuable role in managing stroke. However, evidence regarding the effectiveness of peer support interventions on the psychosocial outcomes of stroke survivors is uncertain. This study aims to develop a nurse-led peer support intervention for stroke survivors based on the Person-Environment-Occupation-Performance Model and evaluate its effects on the psychosocial outcomes of stroke survivors.Methods and analysisThis is an assessor-blinded two-arm randomised controlled trial. A convenience sample of 120 stroke survivors will be recruited from two community centres and one rehabilitation unit in Yangzhou, a medium-sized city in eastern China, with 60 participants each in the intervention and control groups. The participants allocated to the intervention group will receive the nurse-led peer support intervention, which includes 6 weekly peer support sessions facilitated by a nurse and at least one peer facilitator. Participants randomised to the control group will receive the same dose of interpersonal interaction as intervention participants, including weekly individual face-to-face session for 6 weeks. The primary outcomes are social participation and participation self-efficacy. The secondary outcomes are psychosocial distress, social support, stigma towards disease, self-efficacy in managing chronic conditions and quality of life. Data will be collected at baseline, immediately after the intervention and 3 months after the intervention. A process evaluation will be conducted qualitatively and quantitively to examine the mechanism by which the intervention impacts the psychosocial outcomes of stroke survivors. All outcomes will be analysed following the intention to treat principle. Generalised Estimation Equation models will be used to assess the intervention effect.Ethics and disseminationThis protocol was approved by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (CREC Ref. No.: 2021.196-T). All participants will be required to provide written informed consent. Results of the study will be disseminated through publication in peer-reviewed journals and presentation at local or international conferences.Trial registration numberChiCTR2100050853.
| S-EPMC9189841 | biostudies-literature
Project description:Cancer survivors are at an increased risk of experiencing physical and psychological ill-effects following cancer treatment. Rural cancer survivors are at a greater risk of future health problems following a cancer diagnosis compared to their urban counterparts. Physical activity has been targeted as a health promotion priority in cancer survivors. Research indicates that a large portion of cancer survivors do not meet physical activity recommendations. The purpose of this quasi-randomized controlled trial was to test the effectiveness of an online 12-week walking intervention designed for cancer survivors, and to explore its impact on physical health indicators and quality of life outcomes. Steps Toward Improving Diet and Exercise among cancer survivors (STRIDE) is an online resource designed according to Social Cognitive Theory and Self Determination Theory, based on individualized step goal setting. Measures of physiology, physical fitness, and quality of life were taken at the baseline, post-intervention, and three-month follow-up in an Intervention group (n = 46) and active Control group (n = 45). The Control group was provided with a pedometer but did not have access to the online program. Three-factor repeated measures ANOVAs indicated that there were improvements in physical fitness (p < 0.01), systolic blood pressure (p < 0.01), diastolic blood pressure (p < 0.01), waist girth (p < 0.01), mental health (p < 0.05), social functioning (p < 0.01), and general health (p < 0.01), but an increase in bodily pain (p < 0.01), from the baseline to week 12 and the three-month follow-up, irrespective of group allocation. Pedometer interventions, delivered with or without online support and step goal setting, show promise for improving the overall health of cancer survivors, at least in the short term.
| S-EPMC6210292 | biostudies-other
Project description:BackgroundStroke causes lasting brain damage that has numerous impacts on the survivor's physical, psychosocial, and spiritual well-being. Young survivors (< 65 years old) tend to suffer more because of their longer overall survival time. Expressive arts-based intervention is considered a holistic approach for stroke rehabilitation because it allows participants to express their thoughts and emotions through the arts. The group environment also promotes mutual support among participants. The creative art-making process helps expand participants' creativity and imagination as well as promote a sense of aesthetic appreciation. Previous studies have shown the effectiveness of the arts-based intervention in managing stroke and its psychosocial-spiritual comorbidities. Nevertheless, a systematic study has not been conducted, including in young survivors. This trial plans to investigate the effectiveness of an expressive arts-based intervention on bio-psychosocial-spiritual outcomes in young Chinese stroke survivors.Methods/designA single-blind, two-arm cluster randomised control trial with a waitlist control design will be adopted. One hundred and fifty-four stroke survivors, aged 18-64 years with modified Rankin Scale scores of 1-4, will be screened and randomised to either an expressive arts-based intervention group or a treatment-as-usual waitlist control group. The intervention group will receive a 90-min session once a week for a total of 8 weeks. All participants will be assessed three times: at baseline, 8 weeks, and 8 months after the baseline. Study outcomes include measures of depression and anxiety, perceived stress, perceived social support, hope, spiritual well-being, quality of life, salivary cortisol, blood pressure, and heart rate.DiscussionThis study is expected to contribute to the current knowledge on the effectiveness of an arts-based intervention on the holistic wellness of young stroke survivors. The findings will help stroke survivors and healthcare professionals make better choices in selecting practices that will yield maximum benefits, satisfaction, adherence, and sustainability. In addition, the examination of the relationships between bio-psychosocial-spiritual variables will help contribute to the development of holistic care for the survivors.Trial registrationClinicalTrials.gov , NCT03729648 . Registered 31 October 2018 - Retrospectively registered, (329 words).
| S-EPMC7789770 | biostudies-literature
Project description:BACKGROUND:The primary objective of this randomised controlled trial (RCT) is to establish the effectiveness of a novel online quality of life (QoL) intervention tailored for people with late stage (? 10 episodes) bipolar disorder (BD) compared with psychoeducation. Relative to early stage individuals, this late stage group may not benefit as much from existing psychosocial treatments. The intervention is a guided self-help, mindfulness based intervention (MBI) developed in consultation with consumers, designed specifically for web-based delivery, with email coaching support. METHODS/DESIGN:This international RCT will involve a comparison of the effectiveness and cost-effectiveness of two 5-week adjunctive online self-management interventions: Mindfulness for Bipolar 2.0 and an active control (Psychoeducation for Bipolar). A total of 300 participants will be recruited primarily via social media channels. Main inclusion criteria are: a diagnosis of BD (confirmed via a phone-administered structured diagnostic interview), no current mood episode, history of 10 or more mood episodes, no current psychotic features or active suicidality, under the care of a medical practitioner. Block randomisation will be used for allocation to the interventions, and participants will retain access to the program for 6 months. Evaluations will be conducted at pre- and post- treatment, and at 3- and 6- months follow-up. The primary outcome measure will be the Brief Quality of Life in Bipolar Disorder Scale (Brief QoL.BD), collected immediately post-intervention at 5 weeks (T1). Secondary measures include BD-related symptoms (mania, depression, anxiety, stress), time to first relapse, functioning, sleep quality, social rhythm stability and resource use. Measurements will be collected online and via telephone assessments at baseline (T0), 5 weeks (T1), three months (T2) and six months (T3). Candidate moderators (diagnosis, anxiety or substance comorbidities, demographics and current treatments) will be investigated as will putative therapeutic mechanisms including mindfulness, emotion regulation and self-compassion. A cost-effectiveness analysis will be conducted. Acceptability and any unwanted events (including adverse treatment reactions) will be documented and explored. DISCUSSION:This definitive trial will test the effectiveness and cost-effectiveness of a novel QoL focused, mindfulness based, online guided self-help intervention for late stage BD, and investigate its putative mechanisms of therapeutic action. TRIAL REGISTRATION:ClinicalTrials.gov : NCT03197974 . Registered 23 June 2017.
| S-EPMC6044003 | biostudies-literature
Project description:ObjectiveIn Bangladesh, the factors that contribute to the reduced quality of life were not systematically investigated in long-term stroke survivors, and only a few studies have used preference-based measures to assess the quality of life. We sought to assess the quality of life in stroke survivors who comprise physical health status, psychological state, social relationship, and surrounding environment of the stroke patients.MethodsThe quality of life among stroke patients was assessed with a semi-structured questionnaire using the validated Bangla Version of the World Health Organization, Quality-of-Life scale among the patients who survived beyond 28 days of first-ever stroke occurrence presenting in the Department of Physical Medicine and Rehabilitation, Bangabandhu Sheikh Mujib Medical University in the period between November 2020 and October 2021.ResultsOf the 77 patients who were identified as post-stroke patients, the mean score of overall quality of life (as assessed by Q1 and scored in a range of 1-5) was 3.14 ± 1.08. The mean scores of quality of life were highest for the psychological domain (51.18 ± 19.73) followed by environmental (52.08 ± 13.13), social (45.62 ± 22.73), and physical domains (37.18 ± 18.56). According to the classification of the Bangla Version of the World Health Organization, Quality-of-Life, 75.3% had a low physical quality of life, 37.7% had a low psychological quality of life, 53.2% had a low social quality of life, and 53.2% had a moderate environmental quality of life. The average scores for the physical, psychological, social, and environmental domains were notably lower in stroke survivors with comorbid chronic conditions such as hypertension, diabetes, heart disease, asthma or chronic obstructive pulmonary disease, obesity, and ischemic heart disease in comparison to those without such conditions.ConclusionIn our study, post-stroke patients with lower quality of life were associated with factors such as female gender, lower level of education, urban dwellers, and chronic diseases.
| S-EPMC11320675 | biostudies-literature
Project description:BackgroundRecovery after stroke is long-term and demanding. Optimising community-residing stroke survivors' capability to self-manage their health is integral. Recent systematic reviews have shown that stroke self-management programmes were associated with significant improvement in stroke survivors' health-related quality of life and self-efficacy. However some programmes were not designed with an underpinning theoretical framework. The aim of this study is to compare the effectiveness of a nurse-led stroke self-management programme with usual care on recovery of community-residing stroke survivors.Methods/designA single-blinded, two-arm, randomised controlled trial will be conducted. Patients with a history of first or recurrent ischaemic or haemorrhagic stroke who will be discharged to home settings will be recruited from acute stroke units of three acute public hospitals in Hong Kong. The estimated sample size is 160 (80 participants per group). Eligible participants will be randomised to receive either usual care or a 4-week nurse-led community-based self-management programme plus usual care after discharge. The programme, underpinned by Bandura's constructs of self-efficacy and outcome expectation, includes one individual home visit, two community-based group sessions, and three follow-up phone calls. Primary outcomes include stroke survivors' self-efficacy and outcome expectation of performing self-management behaviours. Secondary outcomes include health-related quality of life, satisfaction with performance of self-management behaviours, depressive symptoms, and community reintegration. Participants will be assessed at baseline and at 8 weeks after randomisation. Generalised estimating equations will be performed to evaluate the significance of changes in outcomes over time by treatment condition. Research ethics approvals were obtained.DiscussionIt is expected that stroke survivors receiving the stroke self-management programme will have improved self-efficacy, outcome expectation, and performance of stroke self-management behaviours. Enhanced quality of life and level of community reintegration, and decreased depressive symptoms are also expected. The study results will provide valuable evidence to inform future identification and evaluation of best approach to deliver stroke self-management programmes to enhance community-residing stroke survivors' recovery.Trial registrationClinicalTrials.gov identifier: NCT02112955 ; date of registration: 09/04/2014.
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