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.
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.
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.
Single group
A Brazilian adaptation of the Irish intervention "iHELP Stroke"
BehavioralThe intervention comprises a set of interactive experiential learning activities. A physiotherapist will serve as the coordinator, and other healthcare professionals will be invited to participate as guest speakers. The educational session aims to provide knowledge about stroke (what stroke and recurrent stroke are, their signs and symptoms, and lifestyle-related risk factors). The individual session aims: (1) to identify the current self-reported health status after stroke; (2) to recognize and raise awareness of risk factors associated with lifestyle-related behaviors, including the setting of behavior change goals, which are structured using the SMART Goals method; and (3) to identify the individual's preferences and ability to participate in the intervention program. Each group session comprises six components covered across the six sessions: education, goal setting, physical activity participation, emotional self-regulation, skill training, and peer learning.
Feasibility of recruitment
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)
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)
It will be determined by the ratio between the total number of sessions performed and the total number of sessions offered.
Feasibility of intervention (safety: incidence of treatment-emergent adverse events)
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.
Achievement of the main goal defined by the participants
Goal Attainment Scaling (GAS). The following scores will be identified: initial (or basal) T-score, final (or achieved) T-score, and T-score change (difference between the two measures). These scores will be calculated for all participants in order to identify the degree of achievement of the previously established main goal.
Number and proportion of participants who achieved their previously defined goals
It is possible to categorize the final T-score based on the following classification: goal not achieved, when the T-score \< 50; and goal achieved, when the T-score ≥ 50. Based on this classification, participants will be categorized according to the final (or achieved) T-score, in order to identify the number and proportion of individuals who met the previously defined main goal.
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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
