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Not Yet Recruiting NCT07861789

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

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

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 200
Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Location: Unitat de Suport a la Recerca Terres de l'Ebre Tortosa Tarragona

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 Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07861789). StuddyBuddy aggregates publicly available trial information.