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

Official title

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

Overview

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.

Interventions

• Behavioral A Brazilian adaptation of the Irish intervention "iHELP Stroke"
  The 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

Primary outcome measures

• Feasibility of recruitment [Time frame: Until the main outcome assessment period, which is 3 months.]
• Feasibility of intervention (retention) [Time frame: At baseline and post-intervention (week-8).]
• Feasibility of intervention (attendance) [Time frame: At baseline and post-intervention (week-8).]
• Feasibility of intervention (safety: incidence of treatment-emergent adverse events) [Time frame: During the intervention (8 weeks).]
• Feasibility of intervention (perceived effectiveness) [Time frame: At post-intervention (week-8).]
• Feasibility of measurement [Time frame: At baseline and post-intervention (week-8).]

Secondary outcome measures (2)

• Achievement of the main goal defined by the participants [Time frame: At baseline and post-intervention (week-8).]
• Number and proportion of participants who achieved their previously defined goals [Time frame: At baseline and post-intervention (week-8).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Brazil · 1 center

• Universidade Federal de Minas Gerais — Belo Horizonte

Publications

• Hall P, Lawrence M, Kroll T, Blake C, Matthews J, Lennon O. Reducing risk behaviours after stroke: An overview of reviews interrogating primary study data using the Theoretical Domains Framework. PLoS One. 2024 Apr 26;19(4):e0302364. doi: 10.1371/journal.pone.0302364. eCollection 2024. PMID 38669261
• da Cruz Peniche P, Faria CDCM, Hall P, Lennon O. Effectiveness of behavior change and self-management theoretically-informed telehealth interventions for stroke secondary prevention: An overview of systematic reviews. J Telemed Telecare. 2025 Aug;31(7):961-990. doi: 10.1177/1357633X241238779. Epub 2024 Apr 16. PMID 38627913
• Eldridge SM, Lancaster GA, Campbell MJ, Thabane L, Hopewell S, Coleman CL, Bond CM. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework. PLoS One. 2016 Mar 15;11(3):e0150205. doi: 10.1371/journal.pone.0150205. eCollection 2016. PMID 26978655
• Moore G, Campbell M, Copeland L, Craig P, Movsisyan A, Hoddinott P, Littlecott H, O'Cathain A, Pfadenhauer L, Rehfuess E, Segrott J, Hawe P, Kee F, Couturiaux D, Hallingberg B, Evans R. Adapting interventions to new contexts-the ADAPT guidance. BMJ. 2021 Aug 3;374:n1679. doi: 10.1136/bmj.n1679. PMID 34344699

Identifiers

NCT: NCT07119047 · CAAE: 77083023.0.0000.5149

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗