START program for family caregivers of people with dementia in Brazil
A Brazilian Version of the STrAtegies for RelaTives (START) Intervention in the Unified Health System (SUS): a Controlled Feasibility Trial
This project will try delivering a culturally adapted START coping program to family caregivers of people with dementia in Brazil using trained community health workers to see if it is feasible and acceptable.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Alemão Oswaldo Cruz Academic / other |
| Locations | 1 site (Vitória, Espírito Santo) |
| Trial ID | NCT07096960 on ClinicalTrials.gov |
What this trial studies
This controlled feasibility trial will test a culturally adapted Brazilian version of the START coping program delivered by trained community general health workers across 10 municipalities covering Brazil's five geographic regions. In each municipality two primary care units are randomly assigned to either the immediate intervention or a waitlist control, and caregivers eligible are adults providing regular weekly care to a person with dementia (CDR ≥1) documented in medical records. Community workers receive a 16-hour in-person training plus ongoing remote supervision while delivering the intervention, and outcomes include feasibility, acceptability, caregiver burden, mental health, and quality of life measured at baseline and six months. Municipalities were selected with state health authorities and had to meet population size and dementia diagnosis thresholds to ensure sufficient recruitment.
Who should consider this trial
Good fit: Primary informal caregivers aged 18 or older who live with or near a person with dementia (CDR ≥1) and provide regular weekly emotional or practical support, with the care recipient having an ICD-10 dementia diagnosis, are ideal candidates.
Not a fit: Caregivers who are illiterate, provide only occasional or sporadic help, or whose care recipient is institutionalized are not eligible and are unlikely to receive benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could make an evidence-based, culturally relevant coping program available through primary care to reduce caregiver burden and improve caregiver mental health and quality of life.
How similar studies have performed: Versions of the START program have shown benefits for caregiver mental health in prior trials (notably in the UK), but delivery by community general health workers within Brazil's public system is novel and untested at this scale.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Vitória, Espírito Santo
- Lucas Martins Teixeira — Vitória, Espírito Santo, Brazil (Recruiting)
Study contacts
- Study coordinator: Lucas Martins Teixeira
- Email: lucas.martins@haoc.com.br
- Phone: +55 86 999137014
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.