Feasibility Randomised-Controlled Trial of Online Stroke Interventions

Study Overview
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Brief Summary
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Many people have difficulties organising their behaviour and problem-solving (also known as executive function difficulties) after stroke. This can have serious, wide-ranging consequences for wellbeing and ability to regain independence. Currently, access to psychological interventions after stroke varies and there is not enough evidence to recommend a specific intervention for executive function difficulties after stroke. A short intervention was designed to help with executive function difficulties by making it easier to set goals and achieve them after stroke. The intervention is designed for online delivery to make it accessible to as many stroke survivors as possible. The present trial aims to investigate the acceptability and feasibility of a single blinded randomized controlled trial of this online executive function intervention (active intervention) compared to an online stroke psychoeducation intervention (control intervention).

Official Title
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A Feasibility Randomised-Controlled Trial of Two Online Psychological Interventions for Stroke Survivors

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Getting things done after stroke
* Behavioral: Stroke psychoeducation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of stroke ≥ 18 years of age Capacitous consent to participate Access to a computer / tablet, the internet, and an email address Exclusion Criteria: Another significant mental or physical health condition Current involvement in another research trial Severe depression (over 20 on PHQ-9) Not able to read or understand English Visual, auditory or motor difficulties of a severity that limit the ability to attend to the content of the interventions, read the Participant Information Sheet or complete the consent form and outcome measures Not registered with a GP or unwilling to provide GP information (for reporting suicidal ideation concerns

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 'Getting things done after stroke' - an online executive function intervention<br> | Behavioral: Getting things done after stroke<br>* A two-session, online rehabilitation intervention focussing on cognitive executive functions supplemented with weekly homework tasks.<br>|
| Active Comparator: Stroke psychoeducation<br> | Behavioral: Stroke psychoeducation<br>* A two-session, online stroke psycho-education intervention supplemented with weekly homework tasks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment Rate | Rate of participants recruited into the trial amongst all participants screened | Through study completion, approximately 15 months. | 
| Exclusion Rate | Rate of participants excluded from participating amongst all participants screened | Through study completion, an average of 15 months. | 
| Attrition Rate | Rate of participants and data lost | Through study completion, an average of 15 months. | 
| Follow-up rate | Rate of participants included at 1-month follow-up | Through study completion, an average of 15 months. | 
| Time required to collect and analyze data | Time required for data collection per participant and final analysis | Through study completion, an average of 15 months. | 
| Questionnaire reminders | Number of questionnaire reminders sent and time taken per participant | Through study completion, an average of 15 months. | 
| Support to complete questionnaires | Number of participants requiring support to complete questionnaires and time taken per participant | Through study completion, an average of 15 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The stroke self-efficacy scale (SSES; Jones et al., 2008) | A 13-item measure of confidence for functional performance and aspects of self-management relevant post-stroke. Respondents are asked to rate their confidence that they can do various tasks that may have been difficult after having a stroke using a 4-point scale (0=not at all confident, 3=very confident). | Baseline, post-intervention and at 1-month follow-up. | 
| The Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS, Tennant et al., 2007) | A 7-item questionnaire covering subjective wellbeing and psychological functioning. Respondents are asked to rate each of the items on a scale of 1 to 5 on the basis of how often they had experienced a symptom over the last 2 weeks (1=none of the time, 2=rarely, 3=some of the time, 4= often, 5=all of the time). | Baseline, post-intervention and at 1-month follow-up. | 
| Revised Dysexecutive Questionnaire (DEX-R; Simblett, Ring & Bateman, 2016) | A tool for measuring everyday problems experienced with the dysexecutive syndrome. It consists of 37 items and respondents are asked to rate how often they experience difficulties related to executive functioning (0=never, 1=occasionally, 2=sometimes, 3=fairly often, 4=very often). | Baseline, post-intervention and at 1-month follow-up. | 
| The Patient Health Questionnaire-9 (PHQ-9) | A self-report measure of depression consisting of nine items matching the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria of major depression. Respondents are asked to rate each of the items on a scale of 0 to 3 on the basis of how much a symptom has bothered them over the last 2 weeks (0=not at all, 1=several days, 2=more than half the days, 3=nearly every day). | Screening | 
| The ICECAP-A (ICEpop CAPability measure for Adults; Al-Janabi, Flynn & Coast, 2012) | A measure of capability for the general adult (18+) population for use in economic evaluation. It comprises five attributes (attachment, stability, achievement, enjoyment, and autonomy). Each capability item has four levels of responses. | Baseline, post-intervention and at 1-month follow-up. | 
| Feedback survey | A mixture of open-ended (free text response) and closed (Likert type response) questions to assess trial and intervention acceptability. | Post-intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Executive Functions, Goal Management, Problem-Solving, Psychoeducation, Telerehabilitation