Feasibility Randomised-Controlled Trial of Online Stroke Interventions

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05461937
• Other study ID #: IRAS305848
• Status: Completed
• Phase: N/A
• Start date: June 10, 2022
• Est. completion date: September 15, 2023

Study information

• Verified date: May 2024
• Source: University of East Anglia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 15, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Getting things done after stroke
A two-session, online rehabilitation intervention focussing on cognitive executive functions supplemented with weekly homework tasks.
• Stroke psychoeducation
A two-session, online stroke psycho-education intervention supplemented with weekly homework tasks.

Locations

Country	Name	City	State
United Kingdom	University of East Anglia	Norwich	Norfolk

Sponsors (1)

Lead Sponsor	Collaborator
University of East Anglia

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rate	Rate of participants recruited into the trial amongst all participants screened	Through study completion, approximately 15 months.
Primary	Exclusion Rate	Rate of participants excluded from participating amongst all participants screened	Through study completion, an average of 15 months.
Primary	Attrition Rate	Rate of participants and data lost	Through study completion, an average of 15 months.
Primary	Follow-up rate	Rate of participants included at 1-month follow-up	Through study completion, an average of 15 months.
Primary	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.
Primary	Questionnaire reminders	Number of questionnaire reminders sent and time taken per participant	Through study completion, an average of 15 months.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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
Secondary	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.
Secondary	Feedback survey	A mixture of open-ended (free text response) and closed (Likert type response) questions to assess trial and intervention acceptability.	Post-intervention.