StrokeNCT05461937

Feasibility Randomised-Controlled Trial of Online Stroke Interventions

A study testing Getting things done after stroke and Stroke psychoeducation in people with Stroke, run by University of East Anglia at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Stroke
What is being tested?: Getting things done after stroke and Stroke psychoeducation
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteUnited Kingdom
Study dates: 10 Jun 2022to 15 Sep 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United Kingdom1 site

University of East Anglia
Norwich, Norfolk, NR5 9HB

Other trials in United Kingdom

About this study

Official title: 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).

Conditions: Stroke
Being tested: Getting things done after stroke, Stroke psychoeducation
Keywords: Stroke, Executive Functions, Goal Management, Problem-Solving, Psychoeducation, Telerehabilitation
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Getting things done after strokeBehavioural
A two-session, online rehabilitation intervention focussing on cognitive executive functions supplemented with weekly homework tasks.
Stroke psychoeducationBehavioural
A two-session, online stroke psycho-education intervention supplemented with weekly homework tasks.

Study groups in NCT05461937
Study group	Role	What they receive
'Getting things done after stroke' - an online executive function intervention	Experimental	Not described Receives: Behavioral: Getting things done after stroke
Stroke psychoeducation	Active comparator	Not described Receives: Behavioral: Stroke psychoeducation

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (6)

The stroke self-efficacy scale (SSES; Jones et al., 2008)
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).
Measured: Baseline, post-intervention and at 1-month follow-up.
The Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS, Tennant et al., 2007)
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).
Measured: Baseline, post-intervention and at 1-month follow-up.
Revised Dysexecutive Questionnaire (DEX-R; Simblett, Ring & Bateman, 2016)
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).
Measured: Baseline, post-intervention and at 1-month follow-up.
The Patient Health Questionnaire-9 (PHQ-9)
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).
Measured: Screening
The ICECAP-A (ICEpop CAPability measure for Adults; Al-Janabi, Flynn & Coast, 2012)
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.
Measured: Baseline, post-intervention and at 1-month follow-up.
Feedback survey
A mixture of open-ended (free text response) and closed (Likert type response) questions to assess trial and intervention acceptability.
Measured: Post-intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jun 202215 Sep 2023

First posted18 Jul 2022
Study start10 Jun 2022
Primary completion15 Sep 2023
Study completion15 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05461937
Sponsor's protocol ID: IRAS305848
Status last verified: May 2024
First submitted: 30 Jun 2022
Last updated: 29 May 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 40143638

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The AHA Oneida Study
Oneida Nation Members
Active, not recruiting
Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO)
Acute Ischemic Stroke
Active, not recruiting
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Ischemic Stroke, Systemic Embolism
RecruitingPhase 3
A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)
Atherosclerosis Cardiovascular Disease, Chronic Kidney Disease
Active, not recruiting
Brain Connectivity Analysis
Neural Injury

All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Feasibility Randomised-Controlled Trial of Two Online Psychological Interventions for Stroke Survivors
ClinicalTrials.gov ID: NCT05461937
Acronym / sponsor ID: IRAS305848
Conditions: Stroke
Keywords: Stroke, Executive Functions, Goal Management, Problem-Solving, Psychoeducation, Telerehabilitation
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: University of East AngliaUniversity, hospital or other
Study start: 10 Jun 2022 (actual)
Primary completion: 15 Sep 2023 (actual)
Study completion: 15 Sep 2023 (actual)
First posted: 18 Jul 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
'Getting things done after stroke' - an online executive function intervention	Experimental	Behavioral: Getting things done after stroke
Stroke psychoeducation	Active comparator	Behavioral: Stroke psychoeducation

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Getting things done after strokeA two-session, online rehabilitation intervention focussing on cognitive executive functions supplemented with weekly homework tasks.	Behavioural	'Getting things done after stroke' - an online executive function intervention
Stroke psychoeducationA two-session, online stroke psycho-education intervention supplemented with weekly homework tasks.	Behavioural	Stroke psychoeducation

Primary outcome

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

6 secondary outcomes

The stroke self-efficacy scale (SSES; Jones et al., 2008)
Time frame: 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.
Revised Dysexecutive Questionnaire (DEX-R; Simblett, Ring & Bateman, 2016)
Time frame: Baseline, post-intervention and at 1-month follow-up.
The Patient Health Questionnaire-9 (PHQ-9)
Time frame: 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.
Feedback survey
Time frame: Post-intervention.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
Derived from this study: PubMed 40143638Ene 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.
Individual participant dataSharing planned: No

Related trials for Stroke

Recruiting
The AHA Oneida Study
Oneida Nation Members
Active, not recruiting
Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO)
Acute Ischemic Stroke
Active, not recruiting
Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Ischemic Stroke, Systemic Embolism
RecruitingPhase 3
A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)
Atherosclerosis Cardiovascular Disease, Chronic Kidney Disease
Active, not recruiting
Brain Connectivity Analysis
Neural Injury

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Catherine EL Ford, PhD study director

University of East Anglia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Getting things done after stroke and Stroke psychoeducation in people with Stroke, run by University of East Anglia at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Rate (time frame: Through study completion, approximately 15 months.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05461937, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.