START program for family caregivers of people with dementia in Brazil

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.