Clinical trial NCT06226285: Quality of Life for Carers Through a Person-Centred Technological Solution
Official title: Quality of Life for Carers Through a Person-Centred Technological Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Universidade da Coruña
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Innovation, Spain
name: Center on Information and Communication Technologies
First posted: 2024-01-26
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The project was submitted to the 2021 Call for Strategic Projects oriented to the Ecological and Digital Transition of the Spanish Ministry of Science and Innovation, of the State Plan for Scientific, Technical and Innovation Research 2021-2023, which, in turn, is part of the National Recovery, Transformation and Resilience Plan, with funding from Next Generation funds of the European Union.

The technological solution will offer training contents for informal caregivers, which will enable them to increase their knowledge and acquire new skills, including digital ones, so that this proposal will also contribute to the promotion of education, lifelong learning and skills development. In this way, the TechQoL4Carers project will break the digital divide and promote digital inclusion, through an inclusive and sustainable service that put people at the centre.

The social challenge to which the project responds is the QoL of caregivers. In Spain, 15.3% of the population is in an informal caregiver role. The latest data from 2020 show that 53% of Spanish informal caregivers spend 20 hours or more per week caring, represented by women (58%) and aged between 45 and 64 years (52%). The impact of informal care on people's everyday life is double sided: on the one hand, there is evidence of positive aspects, but on the other hand, negative aspects are reflected on different levels (mental, physical, economic and social). This situation has aggravated due to the global COVID-19 pandemic. Nowadays, health, social and care systems for informal caregivers are needed from a person-centred perspective to promote their health, QoL and empowerment. Technology is a promising tool to provide personalised services for active participation in these processes.

TechQoL4Carers is based on a person-centred development, participatory design techniques and an iterative procedure to obtain the final version of the platform. This platform will consist of a website, interconnected with a mobile application and wearable devices, which will offer a set of personalised services that will allow end users to collect and monitor data on their own QoL, occupational balance and healthy lifestyle; to receive personalised warnings; and to access e-training content as additional support in their care tasks and in their own self-care.

It is structured in 7 Work Packages (WP), aligned with the objectives and developed in specific tasks and deliverables. Three main research stages are highlighted: analysis of evidence and definition of requirements (WP1 and WP2); development of the platform and its integration with wearable devices, artificial intelligence and cybersecurity (WP3 and WP4); and validation of the platform and knowledge generation (WP5 and WP6). For the design, testing and validation of the platform (WP5) a pilot study will be conducted following a mixed methodology (quantitative and qualitative). Questionnaires and interviews as well as testing of the platform will be conducted with informal caregivers in order to obtain a final product that considers the end-user in the whole process.

These results are expected to have a scientific and social impact. Knowledge and evidence will be generated on how to improve the QoL of informal caregivers through technology, providing them with tools that will enable more efficient time management and occupational balance. This can indirectly improve the QoL and wellbeing of the people receiving their care (mainly, older people or people with disability).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in health-related Quality of Life from baseline to post-intervention
timeFrame: Pre-Post: baseline and one-month post-intervention
measure: Change in overall health from baseline to post-intervention
timeFrame: Pre-Post: baseline and one-month post-intervention
measure: Change in care-related QoL from baseline to post-intervention
timeFrame: Pre-Post: baseline and one-month post-intervention
measure: Change in perceived well-being from baseline to post-intervention
timeFrame: Pre-Post: baseline and one-month post-intervention
Secondary outcomes:
measure: Change in caregiver burden from baseline to post-intervention
timeFrame: Pre-Post: baseline and one-month post-intervention
measure: Change in caregiver strain from baseline to post-intervention
timeFrame: Pre-Post: baseline and one-month post-intervention
measure: Change in occupational balance from baseline to post-intervention
timeFrame: Pre-Post: baseline and one-month post-intervention
measure: Change in perceived empowerment from baseline to post-intervention
timeFrame: Pre-Post: baseline and one-month post-intervention
measure: Change in physical activity measured by the Xiaomi Smart Band during intervention
timeFrame: 3 months wearing the Xiaomi Smart Band
measure: Change in sleep measured by the Xiaomi Smart Band during intervention
timeFrame: 3 months wearing the Xiaomi Smart Band
measure: Change in daily functioning measured by TechQoL4Carers platform during the intervention
timeFrame: Once a week during the intervention (three months)
measure: TechQoL4Carers Satisfaction Questionnaire
timeFrame: One month post-intervention
measure: Meaning attributed to participation in the project
timeFrame: One month post-intervention
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Universidade da Coruña
Study officials:
affiliation: Universidade da Coruña
name: Betania Groba, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade da Coruña
name: Laura Nieto-Riveiro, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade da Coruña
name: Javier Pereira, PhD
role: STUDY_CHAIR
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