Condition category
Mental and Behavioural Disorders
Date applied
23/04/2019
Date assigned
24/05/2019
Last edited
03/07/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The care of chronic and/or dependent patients falls mainly on non-professional caregivers and constitutes an intensive and extensive task over the years, compromising the health of the caregiver. Caring for the caregiver is an essential element in ensuring the care of patients and the maintenance of their quality of life, as well as significantly reducing the costs of care and the use of health services. The aim of this study is to evaluate the effectiveness of the "CuidadorasCronicos" website (www.cuidadorascronicos.com) and mobile phone application to promote the positive mental health of non-professional caregivers of people with chronic problems.

Who can participate?
Non-professional caregivers of chronically ill patients, aged over 18, selected from those attending the primary care team and/or users of family associations in the cities of Tarragona, Reus, Tortosa, Barcelona and Alicante (Spain)

What does the study involve?
Caregivers are randomly allocated to one of two groups. The caregivers in the intervention group can access the mobile phone application. This mobile phone application has been designed as an intervention program that lasts at least a month. During a month, the caregiver performs activities related to promoting positive mental health. The mobile phone application includes gamification, motivational phrases and questions to evaluate their emotions over 28 days (4 weeks). The program includes references to the website "CuidadorasCronicos" where the caregiver can continue using this tool after the study. The caregivers in the control group have regular attention from the primary care team. After the study, the app is offered to this group. Measurements are taken in both groups at the beginning of the study, after the first month and then at the third and sixth month. Positive mental health scores are compared between the two groups.

What are the possible benefits and risks of participating?
The results obtained from this study may show the utility of an interventional program to promote positive mental health in caregivers and prevent care burden. Participation in this study does not pose any risk, but there may not be any health benefits from participating in this study.

Where is the study run from?
1. CAP Sant Boi
2. CAP Riu Nord
3. CAP Riu Sud
4. CAP Llevant
5. CAP Jaume I
6. CAP Tarraco
7. CAP Alt Penedés
8. CAP Maria Fortuny
9. CAP Dr. Gimbernat
10. CAP Temple
11. CAP Baix Ebre
12. CAP Roquetes
13. CAP Amposta I

When is the study starting and how long is it expected to run for?
January 2019 to December 2019

Who is funding the study?
Instituto de Salud Carlos III (Ministry of Science, Innovation and Universities co-funded by the European Fund for International Development of the European Union)

Who is the main contact?
1. Dr Carme Ferré-Grau
carme.ferre@urv.cat
2. Dr Nuria Albacar-Rioboó
nuria.albacar@urv.cat
3. Dr Laia Raigal-Aran
laia.raigal@urv.cat

Trial website

http://www.cuidadorascronicos.com/web/infoApp.php

Contact information

Type

Public

Primary contact

Dr Carme Ferré-Grau

ORCID ID

Contact details

Av/Catalunya
35
Tarragona
43002
Spain
+34 649 49 78 17
carme.ferre@urv.cat

Type

Public

Additional contact

Dr Nuria Albacar-Rioboó

ORCID ID

Contact details

Av/Catalunya
35
Tarragona
43302
Spain
+34 620 75 55 60
nuria.albacar@urv.cat

Type

Public

Additional contact

Dr Laia Raigal-Aran

ORCID ID

http://orcid.org/0000-0003-3308-0572

Contact details

Av/Catalunya
35
Tarragona
43002
Spain
+34 638 41 90 18
laia.raigal@urv.cat

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

PI16/01576

Study information

Scientific title

Effectiveness of a program to promote positive mental health through the web and an app "Cuidadorascronicos": a randomized clinical trial

Acronym

Cuidadorascronicos

Study hypothesis

Non-professional caregivers who use the web and the App "CuidadorasCronicos", as a complement to face-to-face care, will have better positive mental health than the nonprofessional caregiver control group that uses only the professional's usual care.

The study primary outcome is:
1. To assess the effectiveness of the web and App "CuidadorasCronicos" in promoting positive mental health for non-professional caregivers of people with chronic health problems.

The study secondary outcomes are:
1. Design an mHealth tool to promote the positive mental health of non-professional caregivers.
2. Design and implement an intervention program to improve overall positive mental health and each of the six factors (personal satisfaction, prosocial attitude, self-control, autonomy, problem-solving, interpersonal relationship skills).
3. Evaluate the total positive mental health and by factors of the pre and post intervention caregivers.
4. To compare the differences in the evolution of the overall positive mental health and by factors between the caregivers of the intervention group with respect to the control group.
5. To identify the degree of adherence to the intervention and satisfaction in the use of the website and the App "CuidadorasCronicos" for caregivers.
6. To measure the degree of use of the web and the App by the caregivers.

Ethics approval

Approved 08/03/2019, Comité Ético Investigación Clínica del IDIAP Jordi Gol, Fundació Institut Universitari per a la recerca d’Atenció Primària de Salut Jordi Gol i Guirina (IDAPJGol), Gran Via Corts Catalanes, 587, 08007 (Barcelona), Spain, Tel: +34 (0)93 482 41 24, Email: idap@idiapjgol.org, ref: P18/207

Study design

Longitudinal and prospective community clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Mental health of caregivers

Intervention

The study involves a control group and an experimental group of non-professional caregivers of chronically ill patients. These will be included in the study from the primary care centres participating in the study. These will be randomly assigned to the control group or intervention. The assignment to the control group and experimental group will be made using the non-commercial Epidat 3.0 software.

In the control group, they will receive regular care from the health professionals in the centre.

In the intervention group, in addition to regular care by the health professional, they will participate in a 1-month program to promote positive mental health through a mobile application (App). For 1 month, they will receive daily activities based on the positive mental health decalogue (Lluch, 2011) and related to the tasks of caring for the family member. The App includes daily motivational phrases, a greeting to evaluate the daily emotional state and basic gamification by the activities performed by the user. The App is related to the website www.cuidadorascronicos.com, which is presented during the month of intervention to be a tool to use after the App program.

Intervention type

Device

Phase

Not Applicable

Drug names

Primary outcome measure

The effectiveness of the website and App "CuidadorasCronicos" in promoting positive mental health for non-professional caregivers of people with chronic health problems, measured using the scale of Positive Mental Health (Lluch, 2008) at the start of the study and at 1, 3, and 6 months

Secondary outcome measures

1. Sociodemographic characteristics of the caregiver measured using an ad hoc questionnaire at the start of the study
2. Caregiving burden measured using Zarit Burden Inventory at the start of the study and at 1, 3, and 6 months
3. Satisfaction with the App measured using questionnaire (intervention group only) at the end of the App intervention

Overall trial start date

01/01/2019

Overall trial end date

31/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Primary, secondary and formal non-professional family caregivers of people with chronic health problems with a minimum of 4 months of experience
2. Caregivers over 18 years of age
3. Caregivers using a mobile device and WhatsApp
4. Access to a mobile device with Android operating system
5. Consent to participate
6. Comprehension and reading of Spanish language

Participant type

Carer

Age group

Adult

Gender

Both

Target number of participants

54 in each group (control and experimental)

Participant exclusion criteria

1. Caregivers with cognitive impairment
2. Caregivers who do not understand Spanish or do not have access to the Internet

Recruitment start date

01/03/2019

Recruitment end date

01/10/2019

Locations

Countries of recruitment

Spain

Trial participating centre

CAP Sant Boi
Sant Boi (Barcelona)
08830
Spain

Trial participating centre

CAP Riu Nord
Santa Coloma de Gramenet (Barcelona)
08921
Spain

Trial participating centre

CAP Riu Sud
Santa Coloma de Gramenet (Barcelona)
08921
Spain

Trial participating centre

CAP Llevant
Tarragona (Tarragona)
43007
Spain

Trial participating centre

CAP Jaume I
Tarragona (Tarragona)
43007
Spain

Trial participating centre

CAP Tarraco
Tarragona (Tarragona)
43007
Spain

Trial participating centre

CAP Alt Penedés
Vilfranca del Penedès (Barcelona)
08720
Spain

Trial participating centre

CAP Maria Fortuny
Reus (Tarragona)
43205
Spain

Trial participating centre

CAP Dr. Gimbernat
Cambrils (Tarragona)
43850
Spain

Trial participating centre

CAP Temple
Tortosa (Tarragona)
43500
Spain

Trial participating centre

CAP Baix Ebre
Tortosa (Tarragona)
43500
Spain

Trial participating centre

CAP Roquetes
Roquetes (Tarragona)
43520
Spain

Trial participating centre

CAP Amposta I
Amposta (Tarragona)
43870
Spain

Sponsor information

Organisation

Universitat Rovira i Vigili

Sponsor details

Department and Faculty of Nursing Av/Catalunya
35
Tarragona
43002
Spain
+34 (0)977 29 94 02
laia.raigal@urv.cat

Sponsor type

University/education

Website

http://www.fi.urv.cat

Funders

Funder type

Government

Funder name

Instituto de Salud Carlos III (Ministry of Science, Innovation and Universities co-funded by the European Fund for International Development of the European Union)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned three publications in a high-impact peer-reviewed journal:
1. The design of the project (June 2019)
2. An App revision over caregivers (May 2019)
3. Results of the study (end of 2019)

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Carme Ferré Grau (carme.ferre@urv.cat). Data will be available at the end of the study (around 2020).

Intention to publish date

31/12/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

03/07/2019: The recruitment end date was changed from 01/06/2019 to 01/10/2019. 24/04/2019: Trial's existence confirmed by the ethics committee.