StrokeNCT07761130
A Feasibility Study of the Improving Health and Lifestyle Programme After Stroke (iHeLP)
A study testing The Improving Health and Lifestyle Programme (iHeLP) in people with Stroke, run by University of Limerick at 2 sites in Ireland.
Trial summary
The goal of this study is to learn if the Improving Healthand Lifestyle Programme (iHeLP) is feasible and acceptable to stroke survivors. The main questions it aims to answer are: Is iHeLP feasible to deliver? Is iHeLP acceptable to people who take part? What effect does iHeLP have on the lifestyle behaviours of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- The Improving Health and Lifestyle Programme (iHeLP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesIreland
- Study dates
- 9 Feb 2026to 10 Jun 2026
- 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
- Community-dwelling
- Adults (≥18 years of age)
- Diagnosis of any type of stroke
- Capacity to provide informed consent,
- Score between 0 (no symptoms) to 3 (moderate disability) on the Modified Rankin Scale.
Who cannot join
- Individuals with physician-confirmed contraindications for undertaking physical activity
- Those with active dementia or delirium
Trial locations and contacts
2 sites in 1 country.
Ireland2 sites
Irish Heart Foundation
Dublin, Leinster
University of Limerick
Limerick, Munster
About this study
Official title: The Improving Health and Lifestyle Programme After Stroke (iHeLP): Feasibility of a Secondary Prevention Intervention to Support Behaviour-Change Post-Stroke
The goal of this study is to learn if the Improving Healthand Lifestyle Programme (iHeLP) is feasible and acceptable to stroke survivors. The main questions it aims to answer are:
- Is iHeLP feasible to deliver?
- Is iHeLP acceptable to people who take part?
- What effect does iHeLP have on the lifestyle behaviours of participants?
Participants will:
- Take part in the iHeLP intervention (consists of a one-to-one interview with the facilitator followed by six weekly group sessions with other stroke survivors)
- Complete questionnaires about their lifestyle during the one-to-one interview and after the intervention.
- Participate in a focus group to discuss their experiences and perceptions of iHeLP.
- Conditions
- Stroke
- Being tested
- The Improving Health and Lifestyle Programme (iHeLP)
- Keywords
- stroke, lifestyle, feasibility, behavior change, behaviour change, secondary prevention
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Improving Health and Lifestyle Programme (iHeLP)Behavioural
The Improving Health and Lifestyle Programme (iHeLP) is an evidence- and theory-informed secondary prevention intervention to support behaviour change and healthy lifestyle participation after stroke. Participants will complete a one-to-one interview (approximately 60 minutes) with the programme facilitator to establish health status and set personalised lifestyle goals. Participants then take part in six weekly group in-person sessions lasting approximately 2 hours each, with each intervention session consisting of six core components: skills training, education, physical activity participation, goal-setting, supported emotional self-regulation and peer learning.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm (iHeLP) | Experimental | Participants in this arm will receive the Improving Health and Lifestyle Programme (iHeLP) intervention. Receives: Behavioral: The Improving Health and Lifestyle Programme (iHeLP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
The total number of people screened and recruited to the study will be recorded, with the recruitment rate calculated as a percentage, with the number of people enrolled (numerator) over the number of eligible participants (denominator).
Measured: During screening to enrollment
Retention
Retention will be calculated as the proportion of individuals who, after enrolment, completed the intervention and all follow-up assessments.
Measured: From enrollment to follow-up assessments (week 8)
Adherence to the intervention schedule
Adherence to the intervention schedule will be assessed through recording participant attendance at all sessions, with reasons for non-attendance documented.
Measured: During the intervention period (week 1 to week 8)
Intervention fidelity
Intervention fidelity will be assessed by recording deviations from the intervention manual
Measured: During the intervention period (week 1 to week 8)
Adverse events
Any adverse events will be recorded during intervention or reported by participants during the study period
Measured: During the intervention period (week 1 to week 8)
Acceptability
The acceptability of intervention to participants will be evaluated quantitatively through a self-report questionnaire designed by the researchers, scored on a 5-point Likert scale. This questionnaire will be guided by the theoretical framework of acceptability and guidance for acceptability questionnaires of healthcare interventions, and encompass key concepts of acceptability relating to affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy. Focus groups with each intervention group will also be completed to develop a comprehensive understanding of the acceptability of the intervention.
Measured: Follow-up assessments (week 8)
Secondary outcomes (6)
Self-rated health.
Self-rated health will be measured using the EuroQol Visual Analogue Scale (EQ-VAS). The EQ-VAS is a component of the EQ-5D-5L used to measure health related quality of life. The EQ-VAS derives information about the respondents' subjective health perception, scored on a vertical visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. Ratings range from 0-100, with higher scores indicating higher self-rated health. The EQ-VAS has demonstrated sufficient construct validity across a broad range of populations.
Measured: Baseline assessments (week 1) and follow-up assessments (week 8)
Physical activity levels
Physical activity levels will be measured using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). The IPAQ-SF is a commonly used questionnaire for assessing physical activity levels in adults and is recommended by international consensus for measuring physical activity after stroke. The IPAQ-SF evaluates the time and frequency spent on walking and moderate to vigorous physical activity in the last seven days measured in MET minutes per week. Sedentary hours per day are also recorded. The final score categorises physical activity levels into low, moderate or high. The IPAQ-SF has demonstrated good content and face validity with stroke survivors with preserved walking ability; moderate to strong correlations were found with objective measures of physical activity (rho: 0.40 to 0.63), with moderate-excellent test-retest stability (κ: 0.844 to 0.881; ICC: 0.533 to 0.917) .
Measured: Baseline assessments (week 1) and follow-up assessments (week 8)
Medication adherence
Medication adherence will be measured using the Five Item Medication Adherence Reporting Scale (MARS-5). The MARS-5 is a self-report scale containing 5-items evaluating intentional and non-intentional causes of nonadherence. regarding medication adherence. Each item is rated on a 5-point Likert scale, and the range of the MARS-5 total score is between 5 and 25. The MARS-5 has been validated in various chronic conditions including the stroke population.
Measured: Baseline assessments (week 1) and follow-up assessments (week 8)
Adherence to the Mediterranean diet
Adherence to the Mediterranean diet will be assessed using the Mediterranean Diet Adherence Screen (MEDAS). The MEDAS is a 14-item questionnaire demonstrated to be a valid and reliable tool to assess adherence to the mediterranean diet across various populations, including those at high cardiovascular risk. The MEDAS is scored from 0-14, with higher scores indicating greater adherence to the Mediterranea diet.
Measured: Baseline assessments (week 1) and follow-up assessments (week 8)
Alcohol consumption
Alcohol consumption will be assessed using the Alcohol Use Disorders Identification Test - Consumption (AUDIT-C). The AUDIT-C is a brief and commonly used alcohol consumption screening tool that has been found to be as accurate as the full 10-item Alcohol Use Disorders Identification Test (AUDIT). It is scored on a scale of 0-12, with higher scores indicating higher risk behaviour.
Measured: Baseline assessments (week 1) to follow-up assessments (week 8)
Severity of depression, anxiety and stress symptoms
Severity of depression, anxiety and stress symptoms will be measured using the Depression, Anxiety, Stress Scale Short Form (DASS-21). It was chosen over separate tools such as the Perceived Stress Scale (PSS) and the Hospital Anxiety and Depression Scale (HADS) as it is a multidimensional scale that will reduce overall assessment burden on participants. The DASS-21 consists of three 7-item scales extracted from the original 42-item scale. Sound psychometric properties have been reported for the DASS in both clinical and non-clinical samples. The DASS excludes many items that may be direct consequences of ABI (e.g. sleep, appetite and sexual dysfunction) and each scale predominantly measures affective and behavioural symptoms. The DASS has demonstrated sound internal consistency, satisfactory test-re-test reliability in an acquired brain injury population, and concurrent validity with the HADS, and is sensitive to change (p<0.01). Higher scores indicate greater symptom severity.
Measured: Baseline assessments (week 1) to follow-up assessments (week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start9 Feb 2026
- Primary completion10 Jun 2026
- Study completion10 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Limerick
- Sponsor type
- University, hospital or other
- Collaborators
- Health Research Board, Ireland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761130
- Sponsor's protocol ID
- 2025_09_06_EHS_Hayes (FA)
- Status last verified
- Aug 2026
- First submitted
- 15 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The anonymised individual participant data underlying the results reported in publications will be made available with a data dictionary.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Improving Health and Lifestyle Programme After Stroke (iHeLP): Feasibility of a Secondary Prevention Intervention to Support Behaviour-Change Post-Stroke
- ClinicalTrials.gov ID
- NCT07761130
- Acronym / sponsor ID
- 2025_09_06_EHS_Hayes (FA)
- Conditions
- Stroke
- Keywords
- stroke, lifestyle, feasibility, behavior change, behaviour change, secondary prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of LimerickUniversity, hospital or other
- Collaborators
- Health Research Board, Ireland
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- 10 Jun 2026 (actual)
- Study completion
- 10 Jun 2026 (actual)
- First posted
- 12 Aug 2026 (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.
The goal of this study is to learn if the Improving Healthand Lifestyle Programme (iHeLP) is feasible and acceptable to stroke survivors. The main questions it aims to answer are:
- Is iHeLP feasible to deliver?
- Is iHeLP acceptable to people who take part?
- What effect does iHeLP have on the lifestyle behaviours of participants?
Participants will:
- Take part in the iHeLP intervention (consists of a one-to-one interview with the facilitator followed by six weekly group sessions with other stroke survivors)
- Complete questionnaires about their lifestyle during the one-to-one interview and after the intervention.
- Participate in a focus group to discuss their experiences and perceptions of iHeLP.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm (iHeLP) | Experimental | Behavioral: The Improving Health and Lifestyle Programme (iHeLP)Participants in this arm will receive the Improving Health and Lifestyle Programme (iHeLP) intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Community-dwelling
- Adults (≥18 years of age)
- Diagnosis of any type of stroke
- Capacity to provide informed consent,
- Score between 0 (no symptoms) to 3 (moderate disability) on the Modified Rankin Scale.
Key exclusion criteria (2 listed)
- Individuals with physician-confirmed contraindications for undertaking physical activity
- Those with active dementia or delirium
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 |
|---|---|---|
| The Improving Health and Lifestyle Programme (iHeLP)The Improving Health and Lifestyle Programme (iHeLP) is an evidence- and theory-informed secondary prevention intervention to support behaviour change and healthy lifestyle participation after stroke. Participants will complete a one-to-one interview (approximately 60 minutes) with the programme facilitator to establish health status and set personalised lifestyle goals. Participants then take part in six weekly group in-person sessions lasting approximately 2 hours each, with each intervention session consisting of six core components: skills training, education, physical activity participation, goal-setting, supported emotional self-regulation and peer learning. | Behavioural | Intervention arm (iHeLP) |
Primary outcome
Recruitment
Time frame: During screening to enrollment
The total number of people screened and recruited to the study will be recorded, with the recruitment rate calculated as a percentage, with the number of people enrolled (numerator) over the number of eligible participants (denominator).
Retention
Time frame: From enrollment to follow-up assessments (week 8)
Retention will be calculated as the proportion of individuals who, after enrolment, completed the intervention and all follow-up assessments.
Adherence to the intervention schedule
Time frame: During the intervention period (week 1 to week 8)
Adherence to the intervention schedule will be assessed through recording participant attendance at all sessions, with reasons for non-attendance documented.
Intervention fidelity
Time frame: During the intervention period (week 1 to week 8)
Intervention fidelity will be assessed by recording deviations from the intervention manual
Adverse events
Time frame: During the intervention period (week 1 to week 8)
Any adverse events will be recorded during intervention or reported by participants during the study period
Acceptability
Time frame: Follow-up assessments (week 8)
The acceptability of intervention to participants will be evaluated quantitatively through a self-report questionnaire designed by the researchers, scored on a 5-point Likert scale. This questionnaire will be guided by the theoretical framework of acceptability and guidance for acceptability questionnaires of healthcare interventions, and encompass key concepts of acceptability relating to affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy. Focus groups with each intervention group will also be completed to develop a comprehensive understanding of the acceptability of the intervention.
6 secondary outcomes
Self-rated health.
Time frame: Baseline assessments (week 1) and follow-up assessments (week 8)
Physical activity levels
Time frame: Baseline assessments (week 1) and follow-up assessments (week 8)
Medication adherence
Time frame: Baseline assessments (week 1) and follow-up assessments (week 8)
Adherence to the Mediterranean diet
Time frame: Baseline assessments (week 1) and follow-up assessments (week 8)
Alcohol consumption
Time frame: Baseline assessments (week 1) to follow-up assessments (week 8)
Severity of depression, anxiety and stress symptoms
Time frame: Baseline assessments (week 1) to follow-up assessments (week 8)
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 12 Aug 2026.
- Individual participant dataSharing planned: Yes. The anonymised individual participant data underlying the results reported in publications will be made available with a data dictionary.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Improving Health and Lifestyle Programme (iHeLP) in people with Stroke, run by University of Limerick at 2 sites in Ireland.
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 5 inclusion and 2 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 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. 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 (time frame: During screening to enrollment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2026.