The Improving Health and Lifestyle Programme After Stroke (iHeLP): Feasibility of a Secondary Prevention Intervention to Support Behaviour-Change Post-Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Limerick
- Enrollment
- 19
- Locations
- 2
- Primary Endpoint
- Recruitment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Individuals with physician-confirmed contraindications for undertaking physical activity
- •Those with active dementia or delirium
Arms & Interventions
Intervention arm (iHeLP)
Participants in this arm will receive the Improving Health and Lifestyle Programme (iHeLP) intervention.
Intervention: The Improving Health and Lifestyle Programme (iHeLP) (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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))
- Severity of depression, anxiety and stress symptoms(Baseline assessments (week 1) to follow-up assessments (week 8))