Implementation of the START Intervention in Brazil: a Controlled Feasibility Trial
A Brazilian Version of the STrAtegies for RelaTives (START) Intervention in the Unified Health System (SUS): a Controlled Feasibility Trial
Hospital Alemão Oswaldo Cruz
90 participants
Jul 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria3
- 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).
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Interventions
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.
Locations(1)
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NCT07096960