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

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFederal University of Minas Gerais

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

10 Participants
are divided into 1 treatment group

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