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A Hybrid Effectiveness-Implementation and Cost-Utility Evaluation of a Support Programme for Informal Carers of People With Dementia in Primary Care (EsCuidar2) (EsCuidar2)

21 de outubro de 2026 atualizado por: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

School of Caring: Evaluation of the Effectiveness, Implementation and Cost-Utility of a Support Programme to Improve the Quality of Life of Carers of People With Dementia in Primary Care

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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

200

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Espanha
    • Tarragona
      • Tortosa, Tarragona, Espanha, 43500
        • Unitat de Suport a la Recerca Terres de l'Ebre
        • Subinvestigador:
          • Alessandra Q Gonçalves, PhD
        • Subinvestigador:
          • José F Sáez, PhD
        • Contato:
        • Investigador principal:
          • Claudia C Romeu, PhD
        • Subinvestigador:
          • Ester G Espelta, PhD
        • Subinvestigador:
          • Nuria Brunet
        • Subinvestigador:
          • Laura Bel
        • Subinvestigador:
          • Georgina Cardona
        • Subinvestigador:
          • Evelin Mascarell
        • Subinvestigador:
          • Rosa D Llorca, PhD
        • Subinvestigador:
          • Itziar Atxutegi
        • Subinvestigador:
          • Misericordia Carles
        • Subinvestigador:
          • Maria José Pérez

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Being an informal caregiver for a person with dementia (ICD-10 codes: G31.84 Cognitive impairment, F03.90 Dementia, F01.5 Vascular dementia, G30 Alzheimer's dementia);
  • Being an informal caregiver for a person with a dependency level of 1 or 2, or a pending dependency assessment, in the Tierras del Ebro region (Catalan Health institute);
  • Being of legal age;
  • Being available to participate in in-person sessions.

Exclusion Criteria:

  • Being an informal caregiver for an institutionalized patient;
  • Having difficulty completing a questionnaire.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Pesquisa de serviços de saúde
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Intervention group of the School of Caring Programme

The programme will be delivered in Primary Care Centre (PCC) training facilities and will consist of two components:

  1. Basic programme: Nine face-to-face theoretical and practical sessions will be delivered fortnightly. The programme will include health education, guidance on social and community resources, cognitive behavioural therapy, problem-solving, skills training, physiotherapy support, and nutritional counselling. Group sessions will be facilitated by a multidisciplinary team comprising professionals from family medicine, nursing, physiotherapy, nutrition, social work, and psychology. Prior workshop-based training will be provided to standardise session delivery.
  2. Ongoing programme: Following completion of the nine core sessions, each Primary Care Centre (PCC) will be encouraged to continue the programme on a fortnightly basis, indefinitely, as part of routine clinical practice.
Outro: 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.
Sem intervenção: Control group

Participants allocated to this group will receive an individual consultation with a primary care family physician or nurse. Care will be tailored to the caregiver's specific needs and will not follow a standardised protocol. Topics that may be addressed include health education, psychological support, and social care-related concerns.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
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
Prazo: 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.
Baseline, 4.5 months (end of the basic programme), and 12 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change from Baseline in Caregiver Burden Assessed by the Zarit Burden Interview (ZBI) at 4.5 and 12 Months
Prazo: Baseline, 4.5 months (end of the basic programme), and 12 months.

Caregiver burden will be measured using the Zarit Burden Interview (ZBI), a validated self-administered instrument assessing the perceived impact of caregiving on emotional, physical, social, and financial well-being. The commonly used 22-item version yields a total score ranging from 0 to 88. Higher scores indicate greater caregiver burden, with increasing scores reflecting increasing levels of perceived burden.
Baseline, 4.5 months (end of the basic programme), and 12 months.
Change from Baseline in Self-Efficacy Assessed by the General Self-Efficacy Scale (GSES) at 4.5 and 12 Months
Prazo: Baseline, 4.5 months (end of the basic programme), and 12 months.

Self-efficacy will be measured using the General Self-Efficacy Scale (GSES), a validated 10-item questionnaire designed to assess an individual's perceived ability to cope with challenging situations and manage difficulties effectively. Total scores range from 10 to 40, with higher scores indicating greater perceived self-efficacy.
Baseline, 4.5 months (end of the basic programme), and 12 months.
Change from Baseline in Mental Well-Being Assessed by the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) at 4.5 and 12 Months
Prazo: Baseline, 4.5 months (end of the basic programme), and 12 months.

Mental well-being will be assessed using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS), a validated 14-item instrument covering positive affect, psychological functioning, and interpersonal relationships. Total scores range from 14 to 70, with higher scores indicating greater positive mental well-being.
Baseline, 4.5 months (end of the basic programme), and 12 months.
Change from Baseline in Perceived Social Support Assessed by the Oslo Social Support Scale (OSSS-3) at 4.5 and 12 Months
Prazo: Baseline, 4.5 months (end of the basic programme), and 12 months.

Social support will be measured using the Oslo Social Support Scale (OSSS-3), a brief validated instrument consisting of three items assessing the availability of close relationships, concern and interest from others, and access to practical support. Total scores range from 3 to 14, with higher scores indicating stronger perceived social support. Scores of 3-8 indicate poor social support, 9-11 moderate social support, and 12-14 strong social support.
Baseline, 4.5 months (end of the basic programme), and 12 months.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Colaboradores

Institut Català de la Salut
University Rovira i Virgili
Servicio Gallego de Salud
Biobizkaia Health Research Institute

Investigadores

  • Investigador principal: Claudia C. Romeu, PhD, Catalan Institute of Health

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de novembro de 2026

Conclusão Primária (Estimado)

1 de julho de 2029

Conclusão do estudo (Estimado)

1 de dezembro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

1 de outubro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

1 de outubro de 2026

Primeira postagem (Real)

6 de outubro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

26 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de outubro de 2026

Última verificação

1 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 26/231-P

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

As the project collects sensitive health data from participants, individual data will not be shared. Aggregated data that do not allow for the identification of individuals will be shared upon request to the principal investigator.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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