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Clinical Trials in Brazil / NCT07096960
Recruiting Not applicable

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

NCT07096960 · tracked via the Priya Life Science Brazil tracker
Phase
Not applicable
Started
2025-07-01
Last updated
2025-07-31

Condition(s) studied

Caregiver Burden of People With Dementia

Investigational drug(s) / intervention(s)

STrAtegies for RelaTives (START) - Brazilian version

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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Lucas Martins Teixeira Vitória Espírito Santo Recruiting

More Hospital Alemão Oswaldo Cruz trials in Brazil

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07096960 on ClinicalTrials.gov ↗ ← All trials in Brazil