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

NCT07096960 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-07-31

No results posted yet for this study

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.

Conditions

  • Caregiver Burden of People With Dementia

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.

Sponsors & Collaborators

  • University College, London

    collaborator OTHER

  • Ministry of Health, Brazil

    collaborator OTHER_GOV

  • Hospital Alemão Oswaldo Cruz

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-08-31
Completion
2026-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07096960 on ClinicalTrials.gov