About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Treatments tested in this trial
- A Brazilian adaptation of the Irish intervention "iHELP Stroke"
Treatment groups
Sponsors and collaborators
Federal University of Minas Gerais
Lead sponsor
FAPEMIG - Fundação de Amparo a Pesquisa do Estado de Minas Gerais
Collaborator
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Collaborator
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Collaborator
Worldwide Universities Network
Collaborator
Pró-reitoria de Pesquisa da Universidade Federal de Minas Gerais
Collaborator