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

October 21, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 4.5 months (end of the basic programme), and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.

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
Time Frame: 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
Time Frame: 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
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Institut Català de la Salut
University Rovira i Virgili
Servicio Gallego de Salud
Biobizkaia Health Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Claudia C. Romeu, PhD, Catalan Institute of Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 26/231-P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings