A HYBRID EFFECTIVENESS-IMPLEMENTATION AND COST-UTILITY EVALUATION OF A SUPPORT PROGRAMME FOR INFORMAL CARERS OF PEOPLE WITH DEMENTIA IN PRIMARY CARE (ESCUIDAR2)

NCT07861789 · tracked via the Priya Life Science Spain tracker

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Phase

Not applicable

Started

2026-10

Last updated

2026-10-06

Condition(s) studied

Quality of Life (Primary Outcome) of Informal Caregivers of People With Dementia Participating in a Multicomponent Programme in Primary Care

Investigational drug(s) / intervention(s)

School of Caring Programme

School of Caring Programme: School of caring is a program for informal caregivers of people with dementia that stands out from other programs by offering a service close to the community and through the leadership of public primary care in a region of Catalonia characterized by scattered rural areas.

Study summary

The aim of this study is to evaluate whether the School of Caring programme improves quality of life and reduces caregiver burden among informal carers of people living with dementia. The study will also examine how the programme is implemented in primary care settings and assess its economic efficiency.

The main questions it aims to answer are:

Does participation in the School of Caring programme improve the quality of life of informal carers of people with dementia? Does the programme reduce the negative impact and burden associated with caregiving? What factors facilitate or hinder the implementation of the programme in primary care centres? Is the programme cost-utility compared with usual care?

Researchers will compare informal carers who participate in the programme with carers who receive usual care.

Participants will:

Take part in nine face-to-face group sessions (one every two weeks) delivered in primary care centres.

Receive health education, information about social and community resources, practical guidance for daily care, physiotherapy and nutritional support, and strategies to promote self-care and emotional well-being.

Share experiences with other carers and participate in peer support activities. Complete study assessments to measure quality of life, caregiver burden and other relevant outcomes throughout the study period.

The study will also collect information on programme implementation and resource use to evaluate the feasibility, sustainability and economic impact of integrating the intervention into routine primary care practice.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Being an informal caregiver for a person with (a) dementia (ICD-10 codes: G31.84 Cognitive impairment, F03.90 Dementia, F01.5 Vascular dementia, G30 Alzheimer's dementia); (b) with a dependency level of 1 or 2, or a pending dependency assessment, in the Tierras del Ebro region (Catalan Health institute); (c) being of legal age; and (d) availability to participate in in-person sessions. Exclusion Criteria: * a) being an informal caregiver for an institutionalized patient, or (b) having difficulty completing a questionnaire.

Primary outcome measure(s)

Change from Baseline in Health-Related Quality of Life Assessed by the Short Form-36 Health Survey Version 2 (SF-36v2) at 4.5 and 12 Months — Baseline, 4.5 months (end of the basic programme), and 12 months
Health-related quality of life (HRQoL) will be assessed using the Short Form-36 Health Survey Version 2 (SF-36v2 Health Survey; QualityMetric/Optum), a validated self-administered questionnaire comprising 36 items covering eight health domains: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. The SF-36v2 will be scored using the QualityMetric norm-based scoring algorithm, generating scores for the eight health domains and the Physical Component Summary (PCS) and Mental Component Summary (MCS). Norm-based scores are standardized against the reference population, with a mean of 50 and a standard deviation of 10; higher scores indicate better health-related quality of life. The SF-36v2 will be completed by all participants.

Trial sites (1)

Facility	City	Region	Status
Unitat de Suport a la Recerca Terres de l'Ebre	Tortosa	Tarragona

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07861789 on ClinicalTrials.gov ↗ ← All trials in Spain