Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-31 @ 5:23 PM
Study NCT ID:
NCT07096960
Status:
RECRUITING
Last Update Posted:
2025-07-31
First Post:
2025-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation of the START Intervention in Brazil: a Controlled Feasibility Trial
Sponsor:
Hospital Alemão Oswaldo Cruz
Organization:
Study Overview
Official Title:
A Brazilian Version of the STrAtegies for RelaTives (START) Intervention in the Unified Health System (SUS): a Controlled Feasibility Trial
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
START/ESCADA
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: