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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
STrAtegies for RelaTives (START) - Brazilian version
BehavioralEight 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.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: START/ESCADA InterventionExperimental treatment 1 intervention
Group B: Waitlist ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Feasibility questionnaire
Feasibility of the START/ESCADA intervention assessed through an online structured questionnaire applied to caregivers and community health workers (CHW), covering domains of acceptability, demand, implementation, practicality, adaptation, integration, and expansion.
Time frame
Approximately 8 weeks post-baseline (after completing the intervention)2
Operational feasibility metrics
Number of caregivers who consented to participate; number and proportion who completed all 8 sessions; average number of weeks to complete 8 sessions; number and proportion of community health workers (CHW) completing training; number of CHW delivering the intervention.
Time frame
Approximately 8 weeks post-baseline (after completing the intervention)3
Qualitative feasibility interviews
Feasibility and acceptability of the START/ESCADA intervention assessed via semi-structured qualitative interviews with managers of primary care units, general health workers (ACS), and caregivers, exploring domains such as acceptability, demand, implementation, practicality, adaptation, integration, and expansion.
Time frame
Approximately 8 weeks post-baseline (after completing the intervention)Secondary outcomes
1
Caregiver burden
Zarit Burden Interview (ZBI), 22-item version; total score ranges from 0 to 88, with higher scores indicating greater caregiver burden.
Time frame
6 months post-baseline2
Anxiety and depression
Hospital Anxiety and Depression Scale (HADS); two subscales (Anxiety, Depression), each ranging from 0 to 21; higher scores indicate greater anxiety or depressive symptoms.
Time frame
6 months post-baseline3
Quality of life (caregiver)
World Health Organization Quality of Life Instrument - Short Form (WHOQOL-BREF); includes four domain scores (Physical Health, Psychological, Social Relationships, Environment), each transformed to a scale from 0 to 100; higher scores indicate better quality of life.
Time frame
6 months post-baseline4
Coping strategies
Brief COPE Inventory; 28 items grouped into 14 subscales (coping strategies), each subscale scored by summing two items (range 2 to 8); higher scores indicate greater use of the specific coping strategy.
Time frame
6 months post-baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital Alemão Oswaldo Cruz
Lead sponsor
University College, London
Collaborator
Ministry of Health, Brazil
Collaborator
Source ClinicalTrials.gov