Brazilian Adaptation of an Intervention Developed in Ireland to Promote Healthy Lifestyle Behaviors Post-stroke: a Feasibility Study

Federal University of Minas Gerais

Status: Enrolling

Conditions: Stroke

Treatments: Behavioral: A Brazilian adaptation of the Irish intervention "iHELP Stroke"

Study type: Interventional

Funder types: Other

Identifiers

NCT07119047

CAAE: 77083023.0.0000.5149

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

A Brazilian adaptation of the Irish intervention "iHELP Stroke"

Experimental group

Description:

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.

Treatment:

Behavioral: A Brazilian adaptation of the Irish intervention "iHELP Stroke"