Implementation of the START Intervention in Brazil: a Controlled Feasibility Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Alemão Oswaldo Cruz
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- STrAtegies for RelaTives (START) - Brazilian version
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Hospital Alemão Oswaldo Cruz
Lead sponsor
University College, London
Collaborator
Ministry of Health, Brazil
Collaborator
Source ClinicalTrials.gov