Feasibility Randomised-Controlled Trial of Online Stroke Interventions

University of East Anglia

Status: Completed

Conditions: Stroke

Treatments: Behavioral: Stroke psychoeducation; Behavioral: Getting things done after stroke

Study type: Interventional

Funder types: Other

Identifiers

NCT05461937

IRAS305848

Details and patient eligibility

About

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).

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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22 participants in 2 patient groups

'Getting things done after stroke' - an online executive function intervention

Experimental group

Treatment:

Behavioral: Getting things done after stroke

Stroke psychoeducation

Active Comparator group

Treatment:

Behavioral: Stroke psychoeducation