Stroke
Conditions
Keywords
stroke, lifestyle, feasibility, behavior change, behaviour change, secondary prevention
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.
Interventions
BEHAVIORALThe 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.
Sponsors
University of Limerick
Health Research Board, Ireland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | 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. |
| Recruitment | 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 | 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 | 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 | During the intervention period (week 1 to week 8) | Intervention fidelity will be assessed by recording deviations from the intervention manual |
| Adverse events | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of depression, anxiety and stress symptoms | Baseline assessments (week 1) to follow-up assessments (week 8) | 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. |
| Self-rated health. | Baseline assessments (week 1) and follow-up assessments (week 8) | 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. |
| Physical activity levels | Baseline assessments (week 1) and follow-up assessments (week 8) | 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) . |
| Medication adherence | Baseline assessments (week 1) and follow-up assessments (week 8) | 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. |
| Adherence to the Mediterranean diet | Baseline assessments (week 1) and follow-up assessments (week 8) | 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. |
| Alcohol consumption | Baseline assessments (week 1) to follow-up assessments (week 8) | 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. |
Countries
Ireland
Outcome results
None listed