Feasibility Randomised-Controlled Trial of Online Stroke Interventions

July 14, 2022 updated by: Catherine Ford, University of East Anglia

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR5 9HB
        • Recruiting
        • University of East Anglia
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Crina G Ene, MSc
        • Principal Investigator:
          • Catherine EL Ford, PhD
        • Sub-Investigator:
          • Fergus Gracey, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 'Getting things done after stroke' - an online executive function intervention
Behavioral: Getting things done after stroke
A two-session, online rehabilitation intervention focussing on cognitive executive functions supplemented with weekly homework tasks.
ACTIVE_COMPARATOR: Stroke psychoeducation
Behavioral: Stroke psychoeducation
A two-session, online stroke psycho-education intervention supplemented with weekly homework tasks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment Rate
Time Frame: Through study completion, approximately 15 months.
Rate of participants recruited into the trial amongst all participants screened
Through study completion, approximately 15 months.
Exclusion Rate
Time Frame: Through study completion, an average of 15 months.
Rate of participants excluded from participating amongst all participants screened
Through study completion, an average of 15 months.
Attrition Rate
Time Frame: Through study completion, an average of 15 months.
Rate of participants and data lost
Through study completion, an average of 15 months.
Follow-up rate
Time Frame: Through study completion, an average of 15 months.
Rate of participants included at 1-month follow-up
Through study completion, an average of 15 months.
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
Through study completion, an average of 15 months.
Questionnaire reminders
Time Frame: Through study completion, an average of 15 months.
Number of questionnaire reminders sent and time taken per participant
Through study completion, an average of 15 months.
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
Through study completion, an average of 15 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, post-intervention and at 1-month follow-up.
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).
Baseline, post-intervention and at 1-month follow-up.
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).
Baseline, post-intervention and at 1-month follow-up.
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).
Screening
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.
Baseline, post-intervention and at 1-month follow-up.
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.
Post-intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of East Anglia

Investigators

  • Study Director: Catherine EL Ford, PhD, University of East Anglia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 10, 2022

Primary Completion (ANTICIPATED)

September 15, 2023

Study Completion (ANTICIPATED)

September 15, 2023

Study Registration Dates

First Submitted

June 30, 2022

First Submitted That Met QC Criteria

July 14, 2022

First Posted (ACTUAL)

July 18, 2022

Study Record Updates

Last Update Posted (ACTUAL)

July 18, 2022

Last Update Submitted That Met QC Criteria

July 14, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRAS305848

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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