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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Alessandra Q Gonçalves, PhD
- 电话号码：1122 +34 977 58 89 11
- 邮箱：aqueiroga.ebre.ics@gencat.cat
学习地点
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Tarragona
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Tortosa、Tarragona、西班牙、43500
- Unitat de Suport a la Recerca Terres de l'Ebre
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副研究员：
- Alessandra Q Gonçalves, PhD
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副研究员：
- José F Sáez, PhD
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接触：
- Alessandra Q Gonçalves, PhD
- 电话号码：1122 +34 977 58 89 11
- 邮箱：aqueiroga.ebre.ics@gencat.cat
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首席研究员：
- Claudia C Romeu, PhD
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副研究员：
- Ester G Espelta, PhD
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副研究员：
- Nuria Brunet
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副研究员：
- Laura Bel
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副研究员：
- Georgina Cardona
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副研究员：
- Evelin Mascarell
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副研究员：
- Rosa D Llorca, PhD
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副研究员：
- Itziar Atxutegi
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副研究员：
- Misericordia Carles
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副研究员：
- Maria José Pérez
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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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无干预：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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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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
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from Baseline in Caregiver Burden Assessed by the Zarit Burden Interview (ZBI) at 4.5 and 12 Months
大体时间：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
大体时间：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
大体时间：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.
|
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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
大体时间：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.
|
合作者和调查者
合作者
调查人员
- 首席研究员：Claudia C. Romeu, PhD、Catalan Institute of Health
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 26/231-P
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
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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