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Completed

NCT Number: NCT05461937

Feasibility Randomised-Controlled Trial of Online Stroke Interventions

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).

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of East Anglia

Norwich, Norfolk, NR5 9HB, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Getting things done after stroke

Behavioral

A two-session, online rehabilitation intervention focussing on cognitive executive functions supplemented with weekly homework tasks.

Stroke psychoeducation

Behavioral

A two-session, online stroke psycho-education intervention supplemented with weekly homework tasks.

Primary outcomes

  1. Recruitment Rate

    Time frame: Through study completion, approximately 15 months.

    Rate of participants recruited into the trial amongst all participants screened

  2. Exclusion Rate

    Time frame: Through study completion, an average of 15 months.

    Rate of participants excluded from participating amongst all participants screened

  3. Attrition Rate

    Time frame: Through study completion, an average of 15 months.

    Rate of participants and data lost

  4. Follow-up rate

    Time frame: Through study completion, an average of 15 months.

    Rate of participants included at 1-month follow-up

  5. Time required to collect and analyze data

    Time frame: Through study completion, an average of 15 months.

    Time required for data collection per participant and final analysis

  6. Questionnaire reminders

    Time frame: Through study completion, an average of 15 months.

    Number of questionnaire reminders sent and time taken per participant

  7. Support to complete questionnaires

    Time frame: Through study completion, an average of 15 months.

    Number of participants requiring support to complete questionnaires and time taken per participant

Secondary outcomes

  1. The stroke self-efficacy scale (SSES; Jones et al., 2008)

    Time frame: Baseline, post-intervention and at 1-month follow-up.

    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).

  2. The Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS, Tennant et al., 2007)

    Time frame: Baseline, post-intervention and at 1-month follow-up.

    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).

  3. Revised Dysexecutive Questionnaire (DEX-R; Simblett, Ring & Bateman, 2016)

    Time frame: Baseline, post-intervention and at 1-month follow-up.

    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).

  4. The Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Screening

    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).

  5. The ICECAP-A (ICEpop CAPability measure for Adults; Al-Janabi, Flynn & Coast, 2012)

    Time frame: Baseline, post-intervention and at 1-month follow-up.

    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.

  6. Feedback survey

    Time frame: Post-intervention.

    A mixture of open-ended (free text response) and closed (Likert type response) questions to assess trial and intervention acceptability.

Sponsors and collaborators

Lead sponsor

University of East Anglia

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 18, 2022
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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