Quality of Life for Carers Through a Person-Centred Technological Solution

NCT06226285 | Completed

• 1 other identifier: 2023_019
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This study is entitled Quality of Life for Carers through a Person-Centred Technological Solution, whose acronym is TechQoL4Carers. The goal of this pilot study is to develop an innovative technological solution (TechQoL4Carers) to improve the Quality of Life (QoL), occupational balance, impact of care, self-management of health, and empowerment of informal caregivers of older people or people with disability. The main question it aims to answer is: Will the routine use of TechQoL4Carers platform have a positive impact on the daily life of informal caregivers? The study will examine these variables in a specific way: QoL, impact of care and burden, occupational balance, health self-management, and empowerment. Informal caregivers will participate in a participatory process of development, testing and validation of the technological platform TechQoL4Carers. At the beginning and end of the study, participants will be asked to answer questionnaires to capture their perspective on the central variables of the study and on the utility and usability of the technology. Then, for three months, participants will:

• use TechQoL4Carers platform on their mobile phone or computer,
• wear the Xiaomi Smart Band 7/8,
• provide weekly reports of health and care related quality of life,
• and receive personalized recommendations and training materials. At the end, they will also participate in an in-depth interview on the impact of the project on their daily activities.

Conditions

Informal Caregivers; Quality of Life; Technology; Activities of Daily Living

Keywords

Quality of Life; informal caregivers; innovation; technological solution; wearable devices; occupational balance; self-management of health; empowerment; person-centred care; participatory processes

Outcome Measures

Primary Outcomes (4)

• Change in health-related Quality of Life from baseline to post-intervention

  Health-related Quality of Life (QoL) will be measured through the self-administered tool EuroQol 5 dimensions 5 levels (EQ-5D-5L). Health state is obtained from the EQ-5D-5L, through its descriptive system with five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The dimensions are scored on a 5-point Likert scale reflecting the level of severity (no problem, slight problems, moderate problems, severe problems, and extreme problems or unable to perform). The health profile or health state describes the level of severity that the person perceives in each dimension and it is represented through an individual code for each dimension scored between 1 and 5 or through a single five-digit code (ranging from 11111 to 55555).

  Pre-Post: baseline and one-month post-intervention

• Change in overall health from baseline to post-intervention

  Health-related QoL will be measured through the self-administered tool EQ-5D-5L. Overall health is derived from a visual analogue scale (VAS) on perceived health, from 0 to 100. In this way, the person scores his or her health on a given day; assigning it a value between 0 (the worst health you can imagine) and 100 (the best health you can imagine).

  Pre-Post: baseline and one-month post-intervention

• Change in care-related QoL from baseline to post-intervention

  Care-related QoL will be measured through the dimensions of the Care-related QoL instrument (CarerQol). The seven dimensions (CarerQol-7D) are fulfillment, relational, mental health, social, financial, perceived support, and physical dimension. They are scored on a Likert scale with three values (1 to 3) indicating the level of severity (no, some, and a lot). Score range: 7 to 21. Score interpretation: The higher the score on the dimensions, the worse the impact of care on the life of the caregiver.

  Pre-Post: baseline and one-month post-intervention

• Change in perceived well-being from baseline to post-intervention

  Well-being related to care-related QoL will be measured through the visual analogue scale (VAS) of the Care-related QoL instrument (CarerQol). The CarerQol-VAS allows rating how happy the person feels at that moment as a measure of general well-being. This construct is scored on a range from 0 (completely unhappy) to 10 (completely happy). Score interpretation: The higher the score, the better the situation in terms of the impact of care.

  Pre-Post: baseline and one-month post-intervention

Secondary Outcomes (9)

• Change in caregiver burden from baseline to post-intervention

  Pre-Post: baseline and one-month post-intervention

• Change in caregiver strain from baseline to post-intervention

  Pre-Post: baseline and one-month post-intervention

• Change in occupational balance from baseline to post-intervention

  Pre-Post: baseline and one-month post-intervention

• Change in perceived empowerment from baseline to post-intervention

  Pre-Post: baseline and one-month post-intervention

• Change in physical activity measured by the Xiaomi Smart Band during intervention

  3 months wearing the Xiaomi Smart Band

Study Arms (1)

Informal caregivers

EXPERIMENTAL

Informal caregivers will participate in a participatory process of development, testing and validation of a technological platform aimed at improving their quality of life, impact of care, occupational balance, self-management of health and empowerment.

Device: TechQoL4Carers Platform

Interventions

TechQoL4Carers Platform DEVICE

The TechQoL4Carers platform is a technological solution that has been designed and developed by the research team in collaboration with the end users. A website and a mobile application integrate the platform. The services offered are: summary of the person's state of health; training content, advice and personalised recommendations based on their situation in terms of quality of life, provision of care, occupational balance, self-management of health and empowerment. It also allows synchronisation with the Xiaomi Smart Band 7/8 activity wristband. The intervention has a duration of three months. Participants will use the services of TechQoL4Carers and wear the Xiaomi Smart Band 7/8 wristband on a regular basis. It is expected that caregivers will access and use the TechQoL4Carers platform, at least once a week, to answer the weekly questionnaire and they will consult, at least once a month, the training contents for self-care and for the provision of care.

Informal caregivers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be 18 years of age or older.
• Perform the role of informal caregiver, being the main caregiver.
• To be living with the person receiving the care.
• Regularly use a smartphone.
• Commit to using the activity wristband on a regular basis during the project development period.

You may not qualify if:

• Have been an informal caregiver for less than one year.
• Be the main caregiver of more than one person in a situation of dependency.
• Have modified legal capacity.

Sponsors & Collaborators

• Universidade da Coruña: lead
• Ministry of Science and Innovation, Spain: collaborator
• Center on Information and Communication Technologies: collaborator

Study Sites (1)

Universidade da Coruña

A Coruña, 15071, Spain

Location

Related Publications (24)

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• Spanish Ministry of Health. Spanish National Health Survey 2011/2012. 2012. https://www.sanidad.gob.es/estadEstudios/estadisticas/encuestaNacional/encuesta2011.htm

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  PMID: 37204853 RESULT

MeSH Terms

Conditions

Empowerment

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Betania Groba, PhD

  Universidade da Coruña

  PRINCIPAL INVESTIGATOR

• Laura Nieto-Riveiro, PhD

  Universidade da Coruña

  PRINCIPAL INVESTIGATOR

• Javier Pereira, PhD

  Universidade da Coruña

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Occupational Therapy-Nursing, PhD in Health Sciences

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 26, 2024
• Study Start: May 1, 2024
• Primary Completion: March 17, 2025
• Study Completion: March 24, 2025
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available after the acceptance for publication of the main findings from de final data set. Time frame estimated: June 2025.
• Access Criteria: Data will be available upon request to the principal investigators. Requests should be emailed to: b.groba@udc.es and laura.nieto@udc.es

Locations

ES (1)