NCT07096960 Implementation of the START Intervention in Brazil: a Controlled Feasibility Trial
| NCT ID | NCT07096960 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Alemão Oswaldo Cruz |
| Condition | Caregiver Burden of People With Dementia |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2025-07-01 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion criteria: * 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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07096960 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Caregiver Burden of People With Dementia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07096960 currently recruiting?
Yes, NCT07096960 is actively recruiting participants. Contact the research team at lucas.martins@haoc.com.br for enrollment information.
Where is the NCT07096960 trial being conducted?
This trial is being conducted at Vitória, Brazil.
Who is sponsoring the NCT07096960 clinical trial?
NCT07096960 is sponsored by Hospital Alemão Oswaldo Cruz. The trial plans to enroll 90 participants.