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RECRUITING
NCT07096960
NA

Implementation of the START Intervention in Brazil: a Controlled Feasibility Trial

Sponsor: Hospital Alemão Oswaldo Cruz

View on ClinicalTrials.gov

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.

Official title: A Brazilian Version of the STrAtegies for RelaTives (START) Intervention in the Unified Health System (SUS): a Controlled Feasibility Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2025-07-01

Completion Date

2026-12-31

Last Updated

2025-07-31

Healthy Volunteers

No

Interventions

BEHAVIORAL

STrAtegies for RelaTives (START) - Brazilian version

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)

Lucas Martins Teixeira

Vitória, Espírito Santo, Brazil