A Brazilian Version of the STrAtegies for RelaTives (START) Intervention in the Unified Health System (SUS): a Controlled Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Feasibility questionnaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •Care recipient with at least one ICD-10 dementia diagnosis code documented in their medical record.
排除标准
- •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).
研究组 & 干预措施
START/ESCADA Intervention
Participants will receive the culturally adapted Brazilian version of START (ESCADA).
干预措施: STrAtegies for RelaTives (START) - Brazilian version (Behavioral)
Waitlist Control
Participants receive usual care and will be offered the START/ESCADA intervention after 6 months at the end of the study.
结局指标
主要结局
Feasibility questionnaire
时间窗: Approximately 8 weeks post-baseline (after completing the intervention)
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.
Operational feasibility metrics
时间窗: Approximately 8 weeks post-baseline (after completing the intervention)
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.
Qualitative feasibility interviews
时间窗: Approximately 8 weeks post-baseline (after completing the intervention)
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.
次要结局
- 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)
- Use of health and social care resources(6 months post-baseline)
研究者
Lucas Martins Teixeira
Principal Investigator
Hospital Alemão Oswaldo Cruz