Stroke
Conditions
Keywords
Stroke, Healthy Lifestyle, Pilot Study, Clinical Trial, Secondary Prevention
Brief summary
Introduction: Stroke presents a high global burden, particularly in low- and middle-income countries such as Brazil. Stroke secondary prevention, in which the adoption of healthy lifestyle behaviors is a key component, is an important strategy for reducing the global burden of stroke. Effective, evidence-based behavioral interventions are needed to support healthy lifestyle adoption after stroke. The "iHELP Stroke: Improving Health and Lifestyle Programme after Stroke", developed in Ireland, is a multimodal behavioral change intervention designed to support healthy lifestyle adoption after stroke. This intervention was adapted to the Brazilian context, following the ADAPT guidance, and was renamed iVIDAVC (Brazilian Portuguese: Intervenção para Melhorar a Saúde e o Estilo de Vida Pós-AVC; corresponding English title: Intervention to Improve Health and Lifestyle After Stroke). A phase I feasibility study of the adapted intervention was completed in July 2025. The next step is to conduct a pilot randomized clinical trial (RCT) to further assess the feasibility of the study procedures and intervention and to obtain preliminary estimates of clinical outcomes. Objective: To assess the feasibility of a pilot RCT of the iVIDAVC, a Brazilian version of a behavior change intervention to support the adoption of healthy lifestyle behaviors after stroke, and to explore its preliminary effects on goal attainment among individuals with stroke in Brazil. Methods: This is a prospective, pilot RCT (Phase II), with two parallel groups, 1:1 allocation, concealed allocation, and blinded outcome assessment. Twenty-four adults with a clinical diagnosis of stroke, living in the community and reporting the need to change at least one lifestyle-related behavior will be recruited in Belo Horizonte, Brazil, and randomly allocated to an experimental group or a control group (12 participants per group). The experimental group will receive the iVIDAVC intervention, a Brazilian version of a behavior change intervention to support the adoption of healthy lifestyle behaviors after stroke, consisting of one educational session, one individual session, and initially six weekly group sessions, with the possibility of additional group sessions according to participants' needs. The control group will receive the educational and individual sessions and remote support for six weeks. Feasibility outcomes will include recruitment, intervention, outcome measurement, blinding, and costs. Clinical outcomes will include the degree of attainment of behavioral change goals, knowledge about stroke, and self-efficacy for behavior change. Assessments will be conducted at baseline, immediately after the intervention, and four weeks after the intervention. Descriptive and estimation-based statistics will be used, without formal hypothesis testing. Conclusions: This pilot RCT will provide information on the feasibility of the study procedures and the delivery of the iVIDAVC, a Brazilian version of a behavior change intervention to support the adoption of healthy lifestyle behaviors after stroke, as well as preliminary estimates of changes in the GAS T-score. The findings will inform refinements to the intervention and study procedures and support the planning of a future larger-scale RCT.
Detailed description
A non-probabilistic sample of 24 participants will be recruited from the community in Belo Horizonte, Brazil. Recruitment strategies will include the distribution of printed flyers in strategic locations, contact with health professionals and researchers, social media and telephone communication, outreach through stroke support groups, dissemination through university and organizational websites and social media, and invitations to participants from a university extension program. All participants will be informed about the study procedures and, upon agreeing to participate, will provide written informed consent. The intervention and outcome assessments will be conducted in a university laboratory setting. A trained researcher blinded to group allocation will be responsible for collecting sociodemographic, anthropometric, and clinical data at baseline, immediately after the intervention, and four weeks after the intervention. Two independent examiners, also blinded to group allocation, will enter the data into statistical software and verify the presence of missing or inconsistent values. Original paper forms will be stored securely, and electronic files will be accessible only to the research team. All participants will be assigned a unique identification code to ensure anonymity. Statistical analyses will be conducted by an independent researcher who will be blinded to group allocation.
Interventions
BEHAVIORALiVIDAVC
The iVIDAVC intervention comprises interactive experiential learning activities coordinated by a physiotherapist, with invited healthcare professionals as guest speakers. The educational session aims to provide knowledge about stroke, signs and symptoms, and lifestyle-related risk factors, as well as the importance of adopting healthy behaviors to reduce the risk of recurrent stroke. The individual session aims to (1) identify the participant's self-reported health status after stroke; (2) increase awareness of lifestyle-related risk factors and support the setting of behavior change goals, using the SMART Goals method; and (3) identify the participant's preferences and ability to participate in the intervention. Each group session includes six components: education, goal setting, physical activity, emotional self-regulation, skills training, and peer learning. These components are addressed across the group sessions and are organized in different ways according to each session.
BEHAVIORALTelephone support
Participants will receive an educational session and an initial individual session. The educational session will provide information about stroke, signs and symptoms, lifestyle-related risk factors and the importance of adopting healthy behaviors. The individual session will aim to (1) identify the participant's self-reported health status after stroke; (2) identify and increase awareness of lifestyle-related risk factors and establish 3 behavior change goals using the SMART Goals method; and (3) identify the participant's preferences and ability to participate in the program. A physiotherapist will call each participant on a fixed day and at a fixed time agreed upon in advance with the participant. Participants will have the opportunity to clarify any questions regarding the achievement of the goals. The number of telephone support contacts will correspond to the total number of group sessions delivered to experimental group. Participants will not participate in the group sessions.
Sponsors
Federal University of Minas Gerais
Fundação de Amparo à Pesquisa do estado de Minas Gerais
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Worldwide Universities Network
Pró-reitoria de Pesquisa da Universidade Federal de Minas Gerais
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessments will be performed by a previously trained examiner, blinded to the allocation of groups. All participants will be instructed not to comment on information about the intervention received. The therapist responsible for delivering the intervention will be blinded to the results of participants' assessments. All statistical analyzes will be performed by an independent examiner, blinded to all procedures performed in the study, including with regard to group allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of stroke, at any stage; * Age ≥ 18 years; * Discharged from hospital and living in the community; * Ability to walk independently with or without a walking device; * 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, or inadequate management of psychosocial factors, such as anxiety, stress, or depression.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of recruitment | Baseline, pre-intervention | 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) | At baseline and immediately post-intervention | 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) | At baseline and immediately post-intervention | It will be determined by the ratio between the total number of sessions performed and the total number of sessions offered. |
| Feasibility of intervention (follow-up of individuals) | At baseline, immediately post-intervention, and follow-up (4 weeks after the end of the intervention) | It will be determined the ratio between the total number of individuals who remained in the same group to which they were initially allocated until follow-up and the total number of individuals who were allocated. |
| Feasibility of intervention (adherence to planned session components) | At each intervention session, over the 8- to 12-session intervention period | It will be assessed by comparing the content delivered during each session with the content specified in the intervention protocol. The proportion of planned session components delivered will be recorded. |
| Feasibility of intervention (safety) | During the intervention (8 to 12 sessions) and follow-up (4 weeks after the end of the intervention) | 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. |
| Acceptability of the intervention | Immediately post-intervention | Acceptability of the intervention will be assessed using participant feedback on five-point Likert scales, with the following response options: "totally agree", "partially agree", "neither agree nor disagree", "partially disagree", and "totally disagree". Participants will rate the following items: (1) overall satisfaction with the activities conducted by the health professional during the intervention; (2) helpfulness of the educational materials in supporting the adoption of a healthy lifestyle; (3) satisfaction with the overall time required for the intervention, considering the total number of weekly sessions; (4) satisfaction with the duration of the intervention sessions, including 1 hour for the educational session, 1 hour for the individual session, and 2 hours for group sessions; and (5) overall satisfaction with the intervention. These scales were informed by previous studies. |
| Feasibility of intervention (perceived effectiveness: lifestyle) | Immediately post-intervention and follow-up (4 weeks after the end of the intervention) | It will be determined by the following question: "Comparing how it was before you performed the intervention and now, do you consider your lifestyle to be healthier: strongly agree, partially agree, neither agree nor disagree, partially disagree, strongly disagree". |
| Feasibility of intervention (perceived effectiveness: overall health) | Immediately post-intervention and follow-up (4 weeks after the end of the intervention) | It will be assessed using participant feedback to the following question: "Compared to before participating in the intervention, how would you rate your overall health now?". Participants will rate their perceived change in overall health using five response options: "much better", "somewhat better", "about the same", "somewhat worse", and "much worse". This assessment will capture participants' perception of changes in their overall health following participation in the iVIDAVC intervention. |
| Feasibility of intervention (perceived effectiveness: healthy lifestyle) | Immediately post-intervention and follow-up (4 weeks after the end of the intervention) | It will be assessed using participant feedback to the following question: "Compared to before participating in the intervention, how would you rate your lifestyle now?". Participants will rate their perceived change in lifestyle using five response options: "much better", "somewhat better", "about the same", "somewhat worse", and "much worse". This assessment will capture participants' perception of changes in their lifestyle following participation in the iVIDAVC intervention. |
| Feasibility of measurement | At baseline, immediately post-intervention, and follow-up (4 weeks after the end of the intervention) | It will be determined by the percentage of clinical outcomes successfully measured (i.e., the ratio between the number of clinical outcomes measured and the number of clinical outcomes proposed to be measured). |
| Feasibility of blinding the outcome assessor | Immediately post-intervention and follow-up (4 weeks after the end of the intervention) | The feasibility of blinding the outcome assessor will be determined by the number and percentage of participants for whom the blinded outcome assessor correctly guesses the treatment allocation. |
| Cost | From the beginning of the study planning through the completion of the intervention and follow-up (4 weeks after the end of the intervention) | Costs associated with staff training (e.g., materials and transportation), recruitment (e.g., telephone calls and printing of folders), screening, assessment of inclusion and exclusion criteria, outcome assessment (e.g., transportation costs for participants and staff, printing of assessment materials, and material costs), and intervention delivery (e.g., telephone calls) will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Attainment of behavioral change goals | At baseline, immediately post-intervention, and follow-up (4 weeks after the end of the intervention) | Goal Attainment Scaling (GAS). The GAS T-score will be used to assess the degree of attainment of the participant's behavioral change goals. Changes in the GAS T-score will be assessed from baseline to post-intervention and from post-intervention to the 4-week follow-up to determine whether goal attainment is maintained, increased, or decreased over time. |
| Knowledge about stroke | At baseline, immediately post-intervention, and follow-up (4 weeks after the end of the intervention) | Knowledge about stroke will be assessed using six questions addressing participants' knowledge of stroke, its signs and symptoms, risk factors for stroke occurrence, the possibility of experiencing a recurrent stroke, the role of healthy lifestyle behaviors in reducing the risk of recurrent stroke, and how to establish goals to maintain a healthy lifestyle. Participants will provide a yes/no response to each question and describe what they know about each topic. Changes in knowledge will be assessed from baseline to post-intervention and from post-intervention to the 4-week follow-up. |
| Self-efficacy for behavior change | At baseline, immediately post-intervention, and follow-up (4 weeks after the end of the intervention) | Self-efficacy for behavior change will be assessed using five statements addressing participants' perceived ability to independently maintain a healthy lifestyle, establish goals, develop action plans to achieve healthy lifestyle goals, develop coping strategies to overcome barriers to maintaining a healthy lifestyle, and self-monitor and record their lifestyle behaviors. Each statement will be rated on a five-point Likert scale ranging from "strongly agree" to "strongly disagree." Changes in self-efficacy will be assessed from baseline to post-intervention and from post-intervention to the 4-week follow-up. |
Countries
Brazil
Contacts
CONTACTChristina Faria, PhD
Outcome results
None listed