Feasibility Randomised-Controlled Trial of Online Stroke Interventions

NCT ID: NCT05461937

Last Updated: 2024-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-10

Study Completion Date

2023-09-15

Brief Summary

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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).

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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

Group Type EXPERIMENTAL

Getting things done after stroke

Intervention Type BEHAVIORAL

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

Stroke psychoeducation

Group Type ACTIVE_COMPARATOR

Stroke psychoeducation

Intervention Type BEHAVIORAL

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

Interventions

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Getting things done after stroke

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

Intervention Type BEHAVIORAL

Stroke psychoeducation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of East Anglia

OTHER

Sponsor Role lead

Responsible Party

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Catherine Ford

Clinical Associate Professor in Clinical Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Catherine EL Ford, PhD

Role: STUDY_DIRECTOR

University of East Anglia

Locations

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University of East Anglia

Norwich, Norfolk, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 40143638 (View on PubMed)

Other Identifiers

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IRAS305848

Identifier Type: -

Identifier Source: org_study_id

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