A Feasibility Study of the Improving Health and Lifestyle Programme After Stroke (iHeLP)

NCT07761130 | Completed

• 1 other identifier: 2025_09_06_EHS_Hayes (FA)
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief 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 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

Keywords

stroke; lifestyle; feasibility; behavior change; behaviour change; secondary prevention

Outcome Measures

Primary Outcomes (6)

• 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).

  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.

  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.

  During the intervention period (week 1 to week 8)

• Intervention fidelity

  Intervention fidelity will be assessed by recording deviations from the intervention manual

  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

  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.

  Follow-up assessments (week 8)

Secondary Outcomes (6)

• Self-rated health.

  Baseline assessments (week 1) and follow-up assessments (week 8)

• Physical activity levels

  Baseline assessments (week 1) and follow-up assessments (week 8)

• Medication adherence

  Baseline assessments (week 1) and follow-up assessments (week 8)

• Adherence to the Mediterranean diet

  Baseline assessments (week 1) and follow-up assessments (week 8)

• Alcohol consumption

  Baseline assessments (week 1) to follow-up assessments (week 8)

Study Arms (1)

Intervention arm (iHeLP)

EXPERIMENTAL

Participants in this arm will receive the Improving Health and Lifestyle Programme (iHeLP) intervention.

Behavioral: The Improving Health and Lifestyle Programme (iHeLP)

Interventions

The Improving Health and Lifestyle Programme (iHeLP) BEHAVIORAL

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.

Intervention arm (iHeLP)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Individuals with physician-confirmed contraindications for undertaking physical activity
• Those with active dementia or delirium

Sponsors & Collaborators

• University of Limerick: lead
• Health Research Board, Ireland: collaborator

Study Sites (2)

Irish Heart Foundation

Dublin, Leinster, Ireland

Location

University of Limerick

Limerick, Munster, Ireland

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: August 12, 2026
• Study Start: February 9, 2026
• Primary Completion: June 10, 2026
• Study Completion: June 10, 2026
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning August 2026 with no end date

Locations

IE (2)