Feasibility Randomised-Controlled Trial of Online Stroke Interventions

NCT05461937 | Completed

• 1 other identifier: IRAS305848
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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).

Conditions

Stroke

Keywords

Stroke; Executive Functions; Goal Management; Problem-Solving; Psychoeducation; Telerehabilitation

Outcome Measures

Primary Outcomes (7)

• Recruitment Rate

  Rate of participants recruited into the trial amongst all participants screened

  Through study completion, approximately 15 months.

• Exclusion Rate

  Rate of participants excluded from participating amongst all participants screened

  Through study completion, an average of 15 months.

• Attrition Rate

  Rate of participants and data lost

  Through study completion, an average of 15 months.

• Follow-up rate

  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 required for data collection per participant and final analysis

  Through study completion, an average of 15 months.

• Questionnaire reminders

  Number of questionnaire reminders sent and time taken per participant

  Through study completion, an average of 15 months.

• 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 Outcomes (6)

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

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

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

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

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

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

• The Patient Health Questionnaire-9 (PHQ-9)

  Screening

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

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

Study Arms (2)

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

EXPERIMENTAL

Behavioral: Getting things done after stroke

Stroke psychoeducation

ACTIVE COMPARATOR

Behavioral: Stroke psychoeducation

Interventions

Getting things done after stroke BEHAVIORAL

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

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

Stroke psychoeducation BEHAVIORAL

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

Stroke psychoeducation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of stroke
• ≥ 18 years of age
• Capacitous consent to participate
• Access to a computer / tablet, the internet, and an email address

You may not qualify if:

• 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

Sponsors & Collaborators

• University of East Anglia: lead

Study Sites (1)

University of East Anglia

Norwich, Norfolk, NR5 9HB, United Kingdom

Location

Related Publications (1)

• Ene CG, Gracey F, Ford C. A feasibility randomized-controlled trial of an executive functioning telerehabilitation intervention for stroke survivors. Brain Inj. 2025;39(9):772-783. doi: 10.1080/02699052.2025.2483449. Epub 2025 Mar 27.

  PMID: 40143638 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Catherine EL Ford, PhD

  University of East Anglia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor in Clinical Psychology

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 18, 2022
• Study Start: June 10, 2022
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)