Clinical trial NCT05461937: Feasibility Randomised-Controlled Trial of Online Stroke Interventions
Official title: A Feasibility Randomised-Controlled Trial of Two Online Psychological Interventions for Stroke Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Executive Functions
Goal Management
Problem-Solving
Psychoeducation
Telerehabilitation
Lead sponsor: University of East Anglia
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Recruitment Rate
timeFrame: Through study completion, approximately 15 months.
measure: Exclusion Rate
timeFrame: Through study completion, an average of 15 months.
measure: Attrition Rate
timeFrame: Through study completion, an average of 15 months.
measure: Follow-up rate
timeFrame: Through study completion, an average of 15 months.
measure: Time required to collect and analyze data
timeFrame: Through study completion, an average of 15 months.
measure: Questionnaire reminders
timeFrame: Through study completion, an average of 15 months.
measure: Support to complete questionnaires
timeFrame: Through study completion, an average of 15 months.
Secondary outcomes:
measure: The stroke self-efficacy scale (SSES; Jones et al., 2008)
timeFrame: Baseline, post-intervention and at 1-month follow-up.
measure: The Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS, Tennant et al., 2007)
timeFrame: Baseline, post-intervention and at 1-month follow-up.
measure: Revised Dysexecutive Questionnaire (DEX-R; Simblett, Ring & Bateman, 2016)
timeFrame: Baseline, post-intervention and at 1-month follow-up.
measure: The Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Screening
measure: The ICECAP-A (ICEpop CAPability measure for Adults; Al-Janabi, Flynn & Coast, 2012)
timeFrame: Baseline, post-intervention and at 1-month follow-up.
measure: Feedback survey
timeFrame: Post-intervention.
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: University of East Anglia
state: Norfolk
Study officials:
affiliation: University of East Anglia
name: Catherine EL Ford, PhD
role: STUDY_DIRECTOR
References: