Quality of LifeEsCuidar2NCT07861789
A Hybrid Effectiveness-Implementation and Cost-Utility Evaluation of a Support Programme for Informal Carers of People With Dementia in Primary Care (EsCuidar2)
A study testing School of Caring Programme in people with Quality of Life, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life
- What is being tested?
- School of Caring Programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2026to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Being an informal caregiver for an institutionalized patient;
- Having difficulty completing a questionnaire.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Unitat de Suport a la Recerca Terres de l'Ebre
Tortosa, Tarragona, 43500
Alessandra Q Gonçalves, PhD, +34 977 58 89 11 ext. 1122, aqueiroga.ebre.ics@gencat.cat
Claudia C Romeu, PhD
About this study
Official title: 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:
Read more
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.
- Conditions
- Quality of Life
- Being tested
- School of Caring Programme
- Keywords
- Dementia, Caregivers, Quality of Life, Social Support, Self Efficacy, Mental Health, Health Education, Primary Health Care, Implementation Science, Randomized Controlled Trials, Cost-utility
- Medical subject headings
- Dementia, Psychological Well-Being, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School of Caring ProgrammeOther
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 group | Role | What they receive |
|---|---|---|
| Intervention group of the School of Caring Programme | Experimental | 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. Receives: Other: School of Caring Programme |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: Baseline, 4.5 months (end of the basic programme), and 12 months
Secondary outcomes (4)
Change from Baseline in Caregiver Burden Assessed by the Zarit Burden Interview (ZBI) at 4.5 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline, 4.5 months (end of the basic programme), and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Català de la Salut, Servicio Gallego de Salud, Biobizkaia Health Research Institute, University Rovira i Virgili
- Responsible party
- Sponsor
- Investigators
- Claudia C. Romeu, PhD, Principal investigator, Catalan Institute of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861789
- Sponsor's protocol ID
- 26/231-P
- Acronym
- EsCuidar2
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07861789
- Acronym / sponsor ID
- EsCuidar2 / 26/231-P
- Conditions
- Quality of Life
- Keywords
- Dementia, Caregivers, Quality of Life, Social Support, Self Efficacy, Mental Health, Health Education, Primary Health Care
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Institut Català de la Salut, Servicio Gallego de Salud, Biobizkaia Health Research Institute, University Rovira i Virgili
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group of the School of Caring Programme | Experimental | Other: School of Caring ProgrammeThe 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Being an informal caregiver for an institutionalized patient;
- Having difficulty completing a questionnaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| School of Caring ProgrammeSchool 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. | Other | Intervention group of the School of Caring Programme |
Primary outcome
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
Time frame: 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.
4 secondary outcomes
Change from Baseline in Caregiver Burden Assessed by the Zarit Burden Interview (ZBI) at 4.5 and 12 Months
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, 4.5 months (end of the basic programme), and 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claudia C. Romeu, PhD principal investigator
Catalan Institute of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing School of Caring Programme in people with Quality of Life, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandra Q Gonçalves, PhD (+34 977 58 89 11 ext. 1122, aqueiroga.ebre.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline, 4.5 months (end of the basic programme), and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.