StrokeNCT07809269
Brazilian Version of an Intervention to Support Healthy Lifestyle Adoption Post-stroke - iVIDAVC
A study testing iVIDAVC and Telephone support in people with Stroke, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- iVIDAVC and Telephone support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, 31270-901
Christina Faria, PhD, +55 (31) 34097448, cdcmf@ufmg.br
About this study
Official title: Brazilian Version of a Behavior Change Intervention to Support Healthy Lifestyle Adoption After Stroke - iVIDAVC: Protocol for a Pilot Randomized Study
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.
Read more
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- iVIDAVC, Telephone support
- Keywords
- Stroke, Healthy Lifestyle, Pilot Study, Clinical Trial, Secondary Prevention
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iVIDAVCBehavioural
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.
Telephone supportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| iVIDAVC | Experimental | The iVIDAVC intervention is a multimodal behavior change programme adapted from the iHELP Stroke to the Brazilian context. The adaptation process followed the ADAPT guidance (Moore et al., 2021), with adaptations addressing geographic, cultural, economic, ethical, legal, political, organizational, service-related, and practice-related aspects. The intervention aims to support the adoption of healthy lifestyle behaviors after stroke: healthy eating, physical activity, smoking cessation, safe alcohol consumption, medication adherence, and management of psychosocial factors. It consists of 1 educational session (approximately 1 hour), 1 individual session (approximately 1 hour), and initially 6 weekly group sessions (approximately 2 hours each). The group sessions address 6 components: education, goal setting, physical activity, emotional self-regulation, skills training, and peer learning. Additional group sessions may be offered according to participants' needs, up to a maximum of 10. Receives: Behavioral: iVIDAVC |
| Telephone support | Sham comparator | Participants allocated to the control group will receive the educational session and the initial individual session of the intervention but will not participate in the group sessions. The educational and individual sessions will be delivered in person in a university laboratory setting. Participants will subsequently receive remote telephone support. The number of remote support contacts will correspond to the total number of group sessions delivered to participants in the experimental group, thereby maintaining a comparable intervention period between groups. Receives: Behavioral: Telephone support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, pre-intervention
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.
Measured: At baseline and immediately post-intervention
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.
Measured: At baseline and immediately post-intervention
Feasibility of intervention (follow-up of individuals)
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.
Measured: At baseline, immediately post-intervention, and follow-up (4 weeks after the end of the intervention)
Feasibility of intervention (adherence to planned session components)
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.
Measured: At each intervention session, over the 8- to 12-session intervention period
Feasibility of intervention (safety)
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.
Measured: During the intervention (8 to 12 sessions) and follow-up (4 weeks after the end of the intervention)
Acceptability of the 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.
Measured: Immediately post-intervention
Feasibility of intervention (perceived effectiveness: lifestyle)
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".
Measured: Immediately post-intervention and follow-up (4 weeks after the end of the intervention)
Feasibility of intervention (perceived effectiveness: overall health)
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.
Measured: Immediately post-intervention and follow-up (4 weeks after the end of the intervention)
Feasibility of intervention (perceived effectiveness: healthy lifestyle)
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.
Measured: Immediately post-intervention and follow-up (4 weeks after the end of the intervention)
Feasibility of measurement
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).
Measured: At baseline, immediately post-intervention, and follow-up (4 weeks after the end of the intervention)
Feasibility of blinding the outcome assessor
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.
Measured: Immediately post-intervention and follow-up (4 weeks after the end of the intervention)
Cost
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.
Measured: From the beginning of the study planning through the completion of the intervention and follow-up (4 weeks after the end of the intervention)
Secondary outcomes (3)
Attainment of behavioral change goals
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.
Measured: At baseline, immediately post-intervention, and follow-up (4 weeks after the end of the intervention)
Knowledge about stroke
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.
Measured: At baseline, immediately post-intervention, and follow-up (4 weeks after the end of the intervention)
Self-efficacy for behavior change
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.
Measured: At baseline, immediately post-intervention, and follow-up (4 weeks after the end of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Principal investigator, Christina Danielli Coelho de Morais Faria, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809269
- Sponsor's protocol ID
- CAAE: 95547126.9.0000.5149
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peniche PC. Comportamentos de estilo de vida saudável no contexto da prevenção secundária do acidente vascular cerebral [tese de doutorado]. Belo Horizonte: Universidade Federal de Minas Gerais; 2025 [cited 2026 Aug 17]. Available from: https://repositorio.ufmg.br/items/f3e9a38a-96b6-496c-af9b-87789c089b20
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.
PubMed 38669261da 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.
PubMed 38627913Eldridge 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.
PubMed 26978655Moore 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.
PubMed 34344699Hall P, Asaba E, Peniche PC, McCartan D, O'Callaghan G, Lennon O. Stakeholder engagement and the co-design of an intervention template to support healthy lifestyle participation after stroke. Design Health. 2025;9(3):257-279. doi:10.1080/24735132.2025.2506311.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brazilian Version of a Behavior Change Intervention to Support Healthy Lifestyle Adoption After Stroke - iVIDAVC: Protocol for a Pilot Randomized Study
- ClinicalTrials.gov ID
- NCT07809269
- Acronym / sponsor ID
- CAAE: 95547126.9.0000.5149
- Conditions
- Stroke
- Keywords
- Stroke, Healthy Lifestyle, Pilot Study, Clinical Trial, Secondary Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- 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
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 9 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iVIDAVC | Experimental | Behavioral: iVIDAVCThe iVIDAVC intervention is a multimodal behavior change programme adapted from the iHELP Stroke to the Brazilian context. The adaptation process followed the ADAPT guidance (Moore et al., 2021), with adaptations addressing geographic, cultural, economic, ethical, legal, political, organizational, service-related, and practice-related aspects. The intervention aims to support the adoption of healthy lifestyle behaviors after stroke: healthy eating, physical activity, smoking cessation, safe alcohol consumption, medication adherence, and management of psychosocial factors. It consists of 1 educational session (approximately 1 hour), 1 individual session (approximately 1 hour), and initially 6 weekly group sessions (approximately 2 hours each). The group sessions address 6 components: education, goal setting, physical activity, emotional self-regulation, skills training, and peer learning. Additional group sessions may be offered according to participants' needs, up to a maximum of 10. |
| Telephone support | Sham comparator | Behavioral: Telephone supportParticipants allocated to the control group will receive the educational session and the initial individual session of the intervention but will not participate in the group sessions. The educational and individual sessions will be delivered in person in a university laboratory setting. Participants will subsequently receive remote telephone support. The number of remote support contacts will correspond to the total number of group sessions delivered to participants in the experimental group, thereby maintaining a comparable intervention period between groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iVIDAVCThe 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. | Behavioural | iVIDAVC |
| Telephone supportParticipants 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. | Behavioural | Telephone support |
Primary outcome
Feasibility of recruitment
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
3 secondary outcomes
Attainment of behavioral change goals
Time frame: At baseline, immediately post-intervention, and follow-up (4 weeks after the end of the intervention)
Knowledge about stroke
Time frame: At baseline, immediately post-intervention, and follow-up (4 weeks after the end of the intervention)
Self-efficacy for behavior change
Time frame: At baseline, immediately post-intervention, and follow-up (4 weeks after the end of the intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- BackgroundPeniche PC. Comportamentos de estilo de vida saudável no contexto da prevenção secundária do acidente vascular cerebral [tese de doutorado]. Belo Horizonte: Universidade Federal de Minas Gerais; 2025 [cited 2026 Aug 17]. Available from: https://repositorio.ufmg.br/items/f3e9a38a-96b6-496c-af9b-87789c089b20
- Background: PubMed 38669261Hall 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.
- Background: PubMed 38627913da 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.
- Background: PubMed 26978655Eldridge 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.
- Background: PubMed 34344699Moore 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.
- BackgroundHall P, Asaba E, Peniche PC, McCartan D, O'Callaghan G, Lennon O. Stakeholder engagement and the co-design of an intervention template to support healthy lifestyle participation after stroke. Design Health. 2025;9(3):257-279. doi:10.1080/24735132.2025.2506311.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iVIDAVC and Telephone support in people with Stroke, run by Federal University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina Faria, PhD (+55 (31) 34097448, cdcmf@ufmg.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment (time frame: Baseline, pre-intervention). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07809269, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.