Caregiver Burden of People With DementiaSTART/ESCADANCT07096960
Implementation of the START Intervention in Brazil: a Controlled Feasibility Trial
A study testing STrAtegies for RelaTives (START) - Brazilian version in people with Caregiver Burden of People With Dementia, run by Hospital Alemão Oswaldo Cruz at 1 site in Brazil.
Trial summary
This controlled trial aims to assess the feasibility of a culturally adapted Brazilian version of the START (STrAtegies for RelaTives) program, a structured coping strategy program designed for family caregivers of people living with dementia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregiver Burden of People With Dementia
- What is being tested?
- STrAtegies for RelaTives (START) - Brazilian version
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2025to 31 Dec 2026
- 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
- Informal caregivers (≥18 years old) who are the primary or one of the primary persons responsible for caring for a family member with dementia, providing regular and sustained emotional or practical support every week, and living in the same household or nearby with frequent face-to-face interaction.
- Care recipient (person with dementia) with Clinical Dementia Rating (CDR) score ≥1.
- Care recipient with at least one ICD-10 dementia diagnosis code documented in their medical record.
Who cannot join
- Illiterate caregivers.
- Caregivers who provide only occasional or sporadic support (less than weekly or without regular caregiving responsibility).
- Care recipients who are institutionalized (e.g., living in long-term care facilities).
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
Lucas Martins Teixeira
Vitória, Espírito Santo
Lucas M Teixeira, +55 86 999137014, lucas.martins@haoc.com.br
About this study
Official title: A Brazilian Version of the STrAtegies for RelaTives (START) Intervention in the Unified Health System (SUS): a Controlled Feasibility Trial
This controlled trial aims to assess the feasibility of a culturally adapted Brazilian version of the START (STrAtegies for RelaTives) program, a structured coping strategy program designed for family caregivers of people living with dementia. The program will be delivered by trained community general health workers (CGHW) in 10 municipalities across Brazil. Outcomes will include measures of feasibility and acceptability, as well as caregiver burden, mental health, and quality of life, assessed at baseline and after 6 months.
Read the detailed description
This study will evaluate the feasibility of the START program in the Brazilian Unified Health System (SUS). The intervention was translated and culturally adapted through a structured process that included expert review and focus groups with mental health professionals and community general health workers (CGHW) to ensure the clarity and cultural relevance of the materials.
The intervention will be delivered by trained CGHW to family caregivers of people living with dementia. CGHW will undergo a 16-hour, in-person training provided by the research team. During the period of the intervention, they will receive ongoing remote supervision to support protocol adherence and address challenges encountered in the field.
Ten municipalities-two from each of the five geographical regions of Brazil-will participate. In each municipality, two primary care units (PCU) will be randomly allocated to either the intervention or the waitlist control group.
The selection of participating municipalities will be conducted in collaboration with each state's Bipartite Inter-managerial Commission (Comissão Intergestora Bipartite, CIB). Municipalities will be eligible if they have ≥100,000 inhabitants and agree to participate. Each will be required to list all PCU with ≥15 dementia diagnoses (ICD-10). If a municipality does not have at least two PCU meeting this threshold, units with ≥10 diagnoses may be considered. From this list, two PCU will be randomly drawn. Eligible pairs must meet two conditions: (1) they must be non-contiguous, and (2) their populations must be demographically similar, as assessed by local authorities. If these two criteria are not met, a new draw will be conducted.
Feasibility and acceptability will be assessed as primary outcomes through operational indicators (e.g., number of sessions completed, adherence, dropouts), structured online questionnaires completed by caregivers and CGHW, and semi-structured qualitative interviews conducted with caregivers, CGHW, and municipal health managers.
Secondary outcomes will include caregiver burden, mental health symptoms, quality of life, coping strategies, and neuropsychiatric symptoms of the care recipient. These outcomes will be measured at baseline and again six months after the intervention using validated instruments including the HADS, ZBI, WHOQOL-Bref, Brief COPE, and NPI.
Intervention fidelity will be assessed through randomly selected audio recordings of sessions and structured checklists completed by independent researchers.
- Conditions
- Caregiver Burden of People With Dementia
- Being tested
- STrAtegies for RelaTives (START) - Brazilian version
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STrAtegies for RelaTives (START) - Brazilian versionBehavioural
Eight individualized, weekly, home-based sessions will be delivered by trained community general health workers (CGHW). The intervention includes coping strategies, behavior management, and communication skills. Caregivers receive printed materials and structured exercises. CGHW receive a facilitator manual.
| Study group | Role | What they receive |
|---|---|---|
| START/ESCADA Intervention | Experimental | Participants will receive the culturally adapted Brazilian version of START (ESCADA). Receives: Behavioral: STrAtegies for RelaTives (START) - Brazilian version |
| Waitlist Control | No intervention | Participants receive usual care and will be offered the START/ESCADA intervention after 6 months at the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility questionnaire
Feasibility of the START/ESCADA intervention assessed through an online structured questionnaire applied to caregivers and community health workers (CHW), covering domains of acceptability, demand, implementation, practicality, adaptation, integration, and expansion.
Measured: Approximately 8 weeks post-baseline (after completing the intervention)
Operational feasibility metrics
Number of caregivers who consented to participate; number and proportion who completed all 8 sessions; average number of weeks to complete 8 sessions; number and proportion of community health workers (CHW) completing training; number of CHW delivering the intervention.
Measured: Approximately 8 weeks post-baseline (after completing the intervention)
Qualitative feasibility interviews
Feasibility and acceptability of the START/ESCADA intervention assessed via semi-structured qualitative interviews with managers of primary care units, general health workers (ACS), and caregivers, exploring domains such as acceptability, demand, implementation, practicality, adaptation, integration, and expansion.
Measured: Approximately 8 weeks post-baseline (after completing the intervention)
Secondary outcomes (6)
Caregiver burden
Zarit Burden Interview (ZBI), 22-item version; total score ranges from 0 to 88, with higher scores indicating greater caregiver burden.
Measured: 6 months post-baseline
Anxiety and depression
Hospital Anxiety and Depression Scale (HADS); two subscales (Anxiety, Depression), each ranging from 0 to 21; higher scores indicate greater anxiety or depressive symptoms.
Measured: 6 months post-baseline
Quality of life (caregiver)
World Health Organization Quality of Life Instrument - Short Form (WHOQOL-BREF); includes four domain scores (Physical Health, Psychological, Social Relationships, Environment), each transformed to a scale from 0 to 100; higher scores indicate better quality of life.
Measured: 6 months post-baseline
Coping strategies
Brief COPE Inventory; 28 items grouped into 14 subscales (coping strategies), each subscale scored by summing two items (range 2 to 8); higher scores indicate greater use of the specific coping strategy.
Measured: 6 months post-baseline
Neuropsychiatric symptoms
Neuropsychiatric Inventory (NPI); assesses 12 neuropsychiatric domains in dementia patients. Each domain score is calculated by multiplying frequency (1-4) by severity (1-3), with domain scores ranging from 0 to 12. The total NPI score ranges from 0 to 144, with higher scores indicating greater neuropsychiatric symptom burden.
Measured: 6 months post-baseline
Use of health and social care resources
Structured questionnaire
Measured: 6 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Jul 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver Burden of People With DementiaStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Alemão Oswaldo Cruz
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London, Ministry of Health, Brazil
- Responsible party
- Principal investigator, Lucas Martins Teixeira, Hospital Alemão Oswaldo Cruz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096960
- Sponsor's protocol ID
- PC CEP HAOC 7.432.280
- Acronym
- START/ESCADA
- Status last verified
- Jul 2025
- First submitted
- 25 Jun 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brazilian Version of the STrAtegies for RelaTives (START) Intervention in the Unified Health System (SUS): a Controlled Feasibility Trial
- ClinicalTrials.gov ID
- NCT07096960
- Acronym / sponsor ID
- START/ESCADA / PC CEP HAOC 7.432.280
- Conditions
- Caregiver Burden of People With Dementia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hospital Alemão Oswaldo CruzUniversity, hospital or other
- Collaborators
- University College, London, Ministry of Health, Brazil
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Jul 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.
This controlled trial aims to assess the feasibility of a culturally adapted Brazilian version of the START (STrAtegies for RelaTives) program, a structured coping strategy program designed for family caregivers of people living with dementia. The program will be delivered by trained community general health workers (CGHW) in 10 municipalities across Brazil. Outcomes will include measures of feasibility and acceptability, as well as caregiver burden, mental health, and quality of life, assessed at baseline and after 6 months.
Detailed description
This study will evaluate the feasibility of the START program in the Brazilian Unified Health System (SUS). The intervention was translated and culturally adapted through a structured process that included expert review and focus groups with mental health professionals and community general health workers (CGHW) to ensure the clarity and cultural relevance of the materials.
The intervention will be delivered by trained CGHW to family caregivers of people living with dementia. CGHW will undergo a 16-hour, in-person training provided by the research team. During the period of the intervention, they will receive ongoing remote supervision to support protocol adherence and address challenges encountered in the field.
Ten municipalities-two from each of the five geographical regions of Brazil-will participate. In each municipality, two primary care units (PCU) will be randomly allocated to either the intervention or the waitlist control group.
The selection of participating municipalities will be conducted in collaboration with each state's Bipartite Inter-managerial Commission (Comissão Intergestora Bipartite, CIB). Municipalities will be eligible if they have ≥100,000 inhabitants and agree to participate. Each will be required to list all PCU with ≥15 dementia diagnoses (ICD-10). If a municipality does not have at least two PCU meeting this threshold, units with ≥10 diagnoses may be considered. From this list, two PCU will be randomly drawn. Eligible pairs must meet two conditions: (1) they must be non-contiguous, and (2) their populations must be demographically similar, as assessed by local authorities. If these two criteria are not met, a new draw will be conducted.
Feasibility and acceptability will be assessed as primary outcomes through operational indicators (e.g., number of sessions completed, adherence, dropouts), structured online questionnaires completed by caregivers and CGHW, and semi-structured qualitative interviews conducted with caregivers, CGHW, and municipal health managers.
Secondary outcomes will include caregiver burden, mental health symptoms, quality of life, coping strategies, and neuropsychiatric symptoms of the care recipient. These outcomes will be measured at baseline and again six months after the intervention using validated instruments including the HADS, ZBI, WHOQOL-Bref, Brief COPE, and NPI.
Intervention fidelity will be assessed through randomly selected audio recordings of sessions and structured checklists completed by independent researchers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| START/ESCADA Intervention | Experimental | Behavioral: STrAtegies for RelaTives (START) - Brazilian versionParticipants will receive the culturally adapted Brazilian version of START (ESCADA). |
| Waitlist Control | No intervention | –Participants receive usual care and will be offered the START/ESCADA intervention after 6 months at the end of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informal caregivers (≥18 years old) who are the primary or one of the primary persons responsible for caring for a family member with dementia, providing regular and sustained emotional or practical support every week, and living in the same household or nearby with frequent face-to-face interaction.
- Care recipient (person with dementia) with Clinical Dementia Rating (CDR) score ≥1.
- Care recipient with at least one ICD-10 dementia diagnosis code documented in their medical record.
Key exclusion criteria (3 listed)
- Illiterate caregivers.
- Caregivers who provide only occasional or sporadic support (less than weekly or without regular caregiving responsibility).
- Care recipients who are institutionalized (e.g., living in long-term care facilities).
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 |
|---|---|---|
| STrAtegies for RelaTives (START) - Brazilian versionEight individualized, weekly, home-based sessions will be delivered by trained community general health workers (CGHW). The intervention includes coping strategies, behavior management, and communication skills. Caregivers receive printed materials and structured exercises. CGHW receive a facilitator manual. | Behavioural | START/ESCADA Intervention |
Primary outcome
Feasibility questionnaire
Time frame: Approximately 8 weeks post-baseline (after completing the intervention)
Feasibility of the START/ESCADA intervention assessed through an online structured questionnaire applied to caregivers and community health workers (CHW), covering domains of acceptability, demand, implementation, practicality, adaptation, integration, and expansion.
Operational feasibility metrics
Time frame: Approximately 8 weeks post-baseline (after completing the intervention)
Number of caregivers who consented to participate; number and proportion who completed all 8 sessions; average number of weeks to complete 8 sessions; number and proportion of community health workers (CHW) completing training; number of CHW delivering the intervention.
Qualitative feasibility interviews
Time frame: Approximately 8 weeks post-baseline (after completing the intervention)
Feasibility and acceptability of the START/ESCADA intervention assessed via semi-structured qualitative interviews with managers of primary care units, general health workers (ACS), and caregivers, exploring domains such as acceptability, demand, implementation, practicality, adaptation, integration, and expansion.
6 secondary outcomes
Caregiver burden
Time frame: 6 months post-baseline
Anxiety and depression
Time frame: 6 months post-baseline
Quality of life (caregiver)
Time frame: 6 months post-baseline
Coping strategies
Time frame: 6 months post-baseline
Neuropsychiatric symptoms
Time frame: 6 months post-baseline
Use of health and social care resources
Time frame: 6 months post-baseline
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 31 Jul 2025.
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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 STrAtegies for RelaTives (START) - Brazilian version in people with Caregiver Burden of People With Dementia, run by Hospital Alemão Oswaldo Cruz 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 3 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 31 Jul 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 Lucas Martins Teixeira (+55 86 999137014, lucas.martins@haoc.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility questionnaire (time frame: Approximately 8 weeks post-baseline (after completing the intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2025.