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

NCT07096960 | Recruiting

• 1 other identifier: PC CEP HAOC 7.432.280
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Caregiver Burden of People With Dementia

Outcome Measures

Primary Outcomes (3)

• 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.

  Approximately 8 weeks post-baseline (after completing the intervention)

• 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.

  Approximately 8 weeks post-baseline (after completing the intervention)

• 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.

  Approximately 8 weeks post-baseline (after completing the intervention)

Secondary Outcomes (6)

• Caregiver burden

  6 months post-baseline

• Anxiety and depression

  6 months post-baseline

• Quality of life (caregiver)

  6 months post-baseline

• Coping strategies

  6 months post-baseline

• Neuropsychiatric symptoms

  6 months post-baseline

Study Arms (2)

START/ESCADA Intervention

EXPERIMENTAL

Participants will receive the culturally adapted Brazilian version of START (ESCADA).

Behavioral: STrAtegies for RelaTives (START) - Brazilian version

Waitlist Control

NO INTERVENTION

Participants receive usual care and will be offered the START/ESCADA intervention after 6 months at the end of the study.

Interventions

STrAtegies for RelaTives (START) - Brazilian version BEHAVIORAL

Eight 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.

START/ESCADA Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital Alemão Oswaldo Cruz: lead
• University College, London: collaborator
• Ministry of Health, Brazil: collaborator

Study Sites (1)

Lucas Martins Teixeira

Vitória, Espírito Santo, Brazil

RECRUITING

Central Study Contacts

Lucas Martins Teixeira

CONTACT

+55 86 999137014; lucas.martins@haoc.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 31, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 31, 2025

Record last verified: 2025-07

Locations

BR (1)