An interventional study of Getting things done after stroke and Stroke psychoeducation in Stroke, sponsored by University of East Anglia. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by University of East Anglia · Not applicable, Interventional, and Treatment
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).
7,443 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's enrollment of 22 is below the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →University of East Anglia is the lead sponsor of 79 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Behavioral: Getting things done after stroke
Behavioral: Stroke psychoeducation
A two-session, online rehabilitation intervention focussing on cognitive executive functions supplemented with weekly homework tasks.
A two-session, online stroke psycho-education intervention supplemented with weekly homework tasks.
Recruitment Rate
Rate of participants recruited into the trial amongst all participants screened
Time frame: Through study completion, approximately 15 months.
Exclusion Rate
Rate of participants excluded from participating amongst all participants screened
Time frame: Through study completion, an average of 15 months.
Attrition Rate
Rate of participants and data lost
Time frame: Through study completion, an average of 15 months.
Follow-up rate
Rate of participants included at 1-month follow-up
Time frame: 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
Time frame: Through study completion, an average of 15 months.
Questionnaire reminders
Number of questionnaire reminders sent and time taken per participant
Time frame: 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
Time frame: Through study completion, an average of 15 months.
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Post-intervention.
Plan to share: No
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University of East Anglia