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

This study will evaluate the feasibility of the START program in the Brazilian Unified Health System (SUS). The intervention was translated and culturally adapted through a structured process that included expert review and focus groups with mental health professionals and community general health workers (CGHW) to ensure the clarity and cultural relevance of the materials.

The intervention will be delivered by trained CGHW to family caregivers of people living with dementia. CGHW will undergo a 16-hour, in-person training provided by the research team. During the period of the intervention, they will receive ongoing remote supervision to support protocol adherence and address challenges encountered in the field.

Ten municipalities-two from each of the five geographical regions of Brazil-will participate. In each municipality, two primary care units (PCU) will be randomly allocated to either the intervention or the waitlist control group.

The selection of participating municipalities will be conducted in collaboration with each state's Bipartite Inter-managerial Commission (Comissão Intergestora Bipartite, CIB). Municipalities will be eligible if they have ≥100,000 inhabitants and agree to participate. Each will be required to list all PCU with ≥15 dementia diagnoses (ICD-10). If a municipality does not have at least two PCU meeting this threshold, units with ≥10 diagnoses may be considered. From this list, two PCU will be randomly drawn. Eligible pairs must meet two conditions: (1) they must be non-contiguous, and (2) their populations must be demographically similar, as assessed by local authorities. If these two criteria are not met, a new draw will be conducted.

Feasibility and acceptability will be assessed as primary outcomes through operational indicators (e.g., number of sessions completed, adherence, dropouts), structured online questionnaires completed by caregivers and CGHW, and semi-structured qualitative interviews conducted with caregivers, CGHW, and municipal health managers.

Secondary outcomes will include caregiver burden, mental health symptoms, quality of life, coping strategies, and neuropsychiatric symptoms of the care recipient. These outcomes will be measured at baseline and again six months after the intervention using validated instruments including the HADS, ZBI, WHOQOL-Bref, Brief COPE, and NPI.

Intervention fidelity will be assessed through randomly selected audio recordings of sessions and structured checklists completed by independent researchers.

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).