Brazilian Adaptation of an Intervention Developed in Ireland to Promote Healthy Lifestyle Behaviors Post-stroke: Protocol for a Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Feasibility of recruitment
Study Overview
Brief Summary
Introduction: Low- and middle-income countries, such as Brazil, are most impacted by the high burden of recurrent stroke. These countries also lack structured interventions to promote the adoption of healthy lifestyle behaviors in the context of stroke secondary prevention. In contrast, high-income countries, such as Ireland, which invest more in research, have more advanced studies on this topic. However, before implementing interventions developed in countries like Ireland in middle-income countries like Brazil, it is necessary to adapt them to account for cultural and socioeconomic differences. Furthermore, once the adaptation is made, it is essential to investigate the feasibility of implementing the intervention in the new context.
Objective: To investigate the feasibility of implementing the Brazilian adaptation of the Irish intervention "iHELP Stroke: Improving Health and Lifestyle Programme", which aims to promote the adoption of healthy lifestyle behaviors post-stroke.
Methodology: This is a phase 1 interventional feasibility study, using a pre- and post-intervention design, to be conducted with ten individuals post-stroke, residing in Belo Horizonte, MG, Brazil. The intervention will consist of eight sessions: one educational session, one individual session, and six group sessions, held weekly. The outcomes of interest will include feasibility (recruitment, intervention, and measurement) and clinical outcomes (achievement of the main goal defined by the participants and the number/proportion of participants who meet this goal). Descriptive statistics will be used for analysis.
Conclusions: The results of this feasibility study will provide valuable insights for designing subsequent phases of a clinical trial.
Detailed Description
A non-probabilistic sample will be recruited from the community. Recruitment strategies include: referrals (e.g, phone numbers obtained from other research projects and university extension programs) and advertisements (e.g. physical folders distributed in public places and electronic pamphlets published on social media). All subjects will be informed about the study procedures and will provide written consent. The intervention and data collection will take place in a university laboratory setting. Two research assistants will enter the data into a statistical software package and verify any missing or apparently wrong values. Original paper forms will be kept in a secure place. Electronic files will be available only to the research team. All individuals will receive an identification code to ensure anonymity. A researcher, not involved in carrying out the intervention, will be responsible for carrying out the statistical analyses.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical diagnosis of subacute or chronic stroke;
- •Age ≥ 18 years;
- •Discharged from hospital and living in the community;
- •Self-identified need to change at least one of the following lifestyle-related behaviors: physical inactivity, unhealthy diet, smoking, harmful alcohol use, or non-adherence to prescribed medication.
Exclusion Criteria
- •Positive screening test for possible cognitive alterations;
- •Pain or other adverse health conditions that compromise the performance of the proposed intervention program, such as vestibular disorders, severe arthritis, or any other diagnosed disease of the nervous system;
- •Presence of comprehensive and/or expressive aphasia.
Arms & Interventions
A Brazilian adaptation of the Irish intervention "iHELP Stroke"
The adaptation process of the Irish intervention "iHELP Stroke: Improving Health and Lifestyle Programme" for the Brazilian context followed the recommendations outlined in the ADAPT guidance (Moore et al., 2021). The adaptations proposed, discussed, and implemented aimed to tailor the intervention to Brazilian specificities, including geographic, cultural, economic, ethical, legal, political, organizational, service-related, and practice-related factors. Participants will undergo the Brazilian version of the adapted "iHELP Stroke" intervention over eight weeks. This includes one educational session (one hour), an initial individual session (one hour), and six group sessions (two hours each), totaling eight weeks of intervention.
Intervention: A Brazilian adaptation of the Irish intervention "iHELP Stroke" (Behavioral)
Outcomes
Primary Outcomes
Feasibility of recruitment
Time Frame: Until the main outcome assessment period, which is 3 months.
It will be determined by the ratio between the total number of eligible individuals (EI) and the total number of screened individuals (SI) (measure=EI/IS), and by the ratio between the total number of eligible individuals (EI) and the total number of recruited individuals (RI) (measure=EI/RI).
Feasibility of intervention (retention)
Time Frame: At baseline and post-intervention (week-8).
It will be determined by the ratio between the total number of individuals who completed the proposed intervention program and the total number of individuals who started the proposed intervention program.
Feasibility of intervention (attendance)
Time Frame: At baseline and post-intervention (week-8).
It will be determined by the ratio between the total number of sessions performed and the total number of sessions offered.
Feasibility of measurement
Time Frame: At baseline and post-intervention (week-8).
It will be determined by the percentage of clinical outcomes measured (ratio between the number of clinical outcomes measured and the number of clinical outcomes proposed to be measured).
Feasibility of intervention (safety: incidence of treatment-emergent adverse events)
Time Frame: During the intervention (8 weeks).
It will be determined by the number and reasons of adverse events (e.g. pain, falls, hospitalization, and death) identified during the period of intervention and follow-up of the individual.
Feasibility of intervention (perceived effectiveness)
Time Frame: At post-intervention (week-8).
It will be determined by the following question: "Comparing how it was before you performed the intervention and now, do you consider your lifestyle to be healthier: strongly agree, partially agree, agree, neither agree nor disagree, disagree, partially disagree, strongly disagree."
Secondary Outcomes
- Achievement of the main goal defined by the participants(At baseline and post-intervention (week-8).)
- Number and proportion of participants who achieved their previously defined goals(At baseline and post-intervention (week-8).)
Investigators
Christina Danielli Coelho de Morais Faria
Doctor
Federal University of Minas Gerais