A Hybrid Effectiveness-Implementation and Cost-Utility Evaluation of a Support Programme for Informal Carers of People With Dementia in Primary Care (EsCuidar2) (EsCuidar2)
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Alessandra Q Gonçalves, PhD
- Telefonní číslo: 1122 +34 977 58 89 11
- E-mail: aqueiroga.ebre.ics@gencat.cat
Studijní místa
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Tarragona
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Tortosa, Tarragona, Španělsko, 43500
- Unitat de Suport a la Recerca Terres de l'Ebre
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Dílčí vyšetřovatel:
- Alessandra Q Gonçalves, PhD
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Dílčí vyšetřovatel:
- José F Sáez, PhD
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Kontakt:
- Alessandra Q Gonçalves, PhD
- Telefonní číslo: 1122 +34 977 58 89 11
- E-mail: aqueiroga.ebre.ics@gencat.cat
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Vrchní vyšetřovatel:
- Claudia C Romeu, PhD
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Dílčí vyšetřovatel:
- Ester G Espelta, PhD
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Dílčí vyšetřovatel:
- Nuria Brunet
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Dílčí vyšetřovatel:
- Laura Bel
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Dílčí vyšetřovatel:
- Georgina Cardona
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Dílčí vyšetřovatel:
- Evelin Mascarell
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Dílčí vyšetřovatel:
- Rosa D Llorca, PhD
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Dílčí vyšetřovatel:
- Itziar Atxutegi
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Dílčí vyšetřovatel:
- Misericordia Carles
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Dílčí vyšetřovatel:
- Maria José Pérez
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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:
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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. |
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Žádný zásah: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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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
Časové okno: Baseline, 4.5 months (end of the basic programme), and 12 months
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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
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change from Baseline in Caregiver Burden Assessed by the Zarit Burden Interview (ZBI) at 4.5 and 12 Months
Časové okno: Baseline, 4.5 months (end of the basic programme), and 12 months.
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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.
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Change from Baseline in Self-Efficacy Assessed by the General Self-Efficacy Scale (GSES) at 4.5 and 12 Months
Časové okno: Baseline, 4.5 months (end of the basic programme), and 12 months.
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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.
|
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Change from Baseline in Mental Well-Being Assessed by the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) at 4.5 and 12 Months
Časové okno: Baseline, 4.5 months (end of the basic programme), and 12 months.
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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.
|
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Change from Baseline in Perceived Social Support Assessed by the Oslo Social Support Scale (OSSS-3) at 4.5 and 12 Months
Časové okno: Baseline, 4.5 months (end of the basic programme), and 12 months.
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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.
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Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Claudia C. Romeu, PhD, Catalan Institute of Health
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Nemoci nervového systému
- Duševní poruchy
- Neurokognitivní poruchy
- Chování
- Dodržování a dodržování léčby
- Zdravotní chování
- Osobní spokojenost
- Compliance pacienta
- Přijímání zdravotní péče pacientem
- Intervence adherence
- Adherence léků
- Demence
- Psychická pohoda
- Zdravotnické vzdělání
Další identifikační čísla studie
- 26/231-P
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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.
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