StrokeNCT07119047
Brazilian Adaptation of an Intervention Developed in Ireland to Promote Healthy Lifestyle Behaviors Post-stroke: a Feasibility Study
A study testing A Brazilian adaptation of the Irish intervention "iHELP Stroke" in people with Stroke, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- A Brazilian adaptation of the Irish intervention "iHELP Stroke"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2025to Oct 2025
- 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 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.
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 Adaptation of an Intervention Developed in Ireland to Promote Healthy Lifestyle Behaviors Post-stroke: Protocol for a Feasibility Study
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.
Read more
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- A Brazilian adaptation of the Irish intervention "iHELP Stroke"
- Keywords
- Stroke, Healthy Lifestyle, Feasibility 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.
A Brazilian adaptation of the Irish intervention "iHELP Stroke"Behavioural
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 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.
| Study group | Role | What they receive |
|---|---|---|
| A Brazilian adaptation of the Irish intervention "iHELP Stroke" | Experimental | The adaptation process of the Irish intervention "iHELP Stroke: Improving Health and Lifestyle Programme" for the Brazilian context followed the recommendations outlined in the ADAPT guidance (Moore et al., 2021). The adaptations proposed, discussed, and implemented aimed to tailor the intervention to Brazilian specificities, including geographic, cultural, economic, ethical, legal, political, organizational, service-related, and practice-related factors. Participants will undergo the Brazilian version of the adapted "iHELP Stroke" intervention over eight weeks. This includes one educational session (one hour), an initial individual session (one hour), and six group sessions (two hours each), totaling eight weeks of intervention. Receives: Behavioral: A Brazilian adaptation of the Irish intervention "iHELP Stroke" |
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: Until the main outcome assessment period, which is 3 months.
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 post-intervention (week-8).
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 post-intervention (week-8).
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.
Measured: During the intervention (8 weeks).
Feasibility of intervention (perceived effectiveness)
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, agree, neither agree nor disagree, disagree, partially disagree, strongly disagree."
Measured: At post-intervention (week-8).
Feasibility of measurement
It will be determined by the percentage of clinical outcomes measured (ratio between the number of clinical outcomes measured and the number of clinical outcomes proposed to be measured).
Measured: At baseline and post-intervention (week-8).
Secondary outcomes (2)
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.
Measured: At baseline and post-intervention (week-8).
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.
Measured: At baseline and post-intervention (week-8).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 May 2025
- Primary completionAug 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- FAPEMIG - Fundação de Amparo a 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
- NCT07119047
- Sponsor's protocol ID
- CAAE: 77083023.0.0000.5149
- Status last verified
- Aug 2025
- First submitted
- 13 Jun 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
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 34344699
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brazilian Adaptation of an Intervention Developed in Ireland to Promote Healthy Lifestyle Behaviors Post-stroke: Protocol for a Feasibility Study
- ClinicalTrials.gov ID
- NCT07119047
- Acronym / sponsor ID
- CAAE: 77083023.0.0000.5149
- Conditions
- Stroke
- Keywords
- Stroke, Healthy Lifestyle, Feasibility Study, Clinical Trial, Secondary Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- FAPEMIG - Fundação de Amparo a 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
- 1 May 2025 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 12 Aug 2025 (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: 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A Brazilian adaptation of the Irish intervention "iHELP Stroke" | Experimental | Behavioral: A Brazilian adaptation of the Irish intervention "iHELP Stroke"The adaptation process of the Irish intervention "iHELP Stroke: Improving Health and Lifestyle Programme" for the Brazilian context followed the recommendations outlined in the ADAPT guidance (Moore et al., 2021). The adaptations proposed, discussed, and implemented aimed to tailor the intervention to Brazilian specificities, including geographic, cultural, economic, ethical, legal, political, organizational, service-related, and practice-related factors. Participants will undergo the Brazilian version of the adapted "iHELP Stroke" intervention over eight weeks. This includes one educational session (one hour), an initial individual session (one hour), and six group sessions (two hours each), totaling eight weeks of intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| 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 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. | Behavioural | A Brazilian adaptation of the Irish intervention "iHELP Stroke" |
Primary outcome
Feasibility of recruitment
Time frame: Until the main outcome assessment period, which is 3 months.
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 post-intervention (week-8).
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 post-intervention (week-8).
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)
Time frame: During the intervention (8 weeks).
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.
Feasibility of intervention (perceived effectiveness)
Time frame: At post-intervention (week-8).
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, agree, neither agree nor disagree, disagree, partially disagree, strongly disagree."
Feasibility of measurement
Time frame: At baseline and post-intervention (week-8).
It will be determined by the percentage of clinical outcomes measured (ratio between the number of clinical outcomes measured and the number of clinical outcomes proposed to be measured).
2 secondary outcomes
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).
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 12 Aug 2025.
- 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.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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 A Brazilian adaptation of the Irish intervention "iHELP Stroke" 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 4 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 12 Aug 2025. 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. 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: Until the main outcome assessment period, which is 3 months.). The study lists 6 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 NCT07119047, which also lists 4 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 12 Aug 2025.