Informal CaregiversTechQoL4CarersNCT06226285
Quality of Life for Carers Through a Person-Centred Technological Solution
A study testing TechQoL4Carers Platform in people with Informal Caregivers and Quality of Life, run by Universidade da Coruña at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Informal Caregivers, Quality of Life, Technology
- What is being tested?
- TechQoL4Carers Platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2024to 24 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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).
- Being tested
- TechQoL4Carers Platform
- Keywords
- Quality of Life, informal caregivers, innovation, technological solution, wearable devices, occupational balance, self-management of health, empowerment, person-centred care, participatory processes
- Medical subject headings
- Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TechQoL4Carers PlatformDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: TechQoL4Carers Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Pre-Post: baseline and one-month post-intervention
Secondary outcomes (9)
Change in caregiver burden from baseline to post-intervention
The Zarit Burden Interview (ZBI) is a questionnaire designed for the caregiving population to assess the level of burden and to detect possible caregiving stressors. The 22-item version is used, scored from 1 to 5. Score range: 22 to 110. Score interpretation with two cut-off points: no burden, 22 to 46 points; mild burden, 47 to 55 points; and severe burden, 56 to 110 points.
Measured: Pre-Post: baseline and one-month post-intervention
Change in caregiver strain from baseline to post-intervention
The Caregiver Strain Index (CBI) or Robinson Index is a 13-item tool for caregivers to measure perceived strain, and detect burden and possible stressors related to caregiving. Each item is answered in a dichotomous way: yes or no. Score range: 0 to 13. Score interpretation: Scores of 7 or more, identify caregivers at risk for high caregiving strain or burden.
Measured: Pre-Post: baseline and one-month post-intervention
Change in occupational balance from baseline to post-intervention
Occupational balance will be measured through the Occupational Balance Questionnaire, Spanish version (OBQ-E).
This self-administered tool of 13 items is scored on a six-step ordinal scale, ranging from 0 (completely disagree) to 5 (completely agree). It evaluates the person's current experience with occupational balance. Score range: 0 to 65. Score interpretation: The results show that the higher the score, the higher the occupational balance.
Measured: Pre-Post: baseline and one-month post-intervention
Change in perceived empowerment from baseline to post-intervention
The Psychological Empowerment Instrument (PEI) will be used to assess changes in informal caregivers' perceptions of empowerment.
It is a self-administered instrument that measures psychological empowerment in the work environment, considering four cognitive dimensions: competence, meaning, self-determination, and impact. The Spanish version of the PEI comprises 13 items divided among the four dimensions and scored on a 7-point Likert scale. This version will be used in the study replacing the references to work and the role of the workers with terms associated with care and caregivers. Score range: 7 to 91 points. Score interpretation: The higher the score, the higher the level of psychological empowerment.
Measured: Pre-Post: baseline and one-month post-intervention
Change in physical activity measured by the Xiaomi Smart Band during intervention
In the study, participants will use the Xiaomi Smart Band activity wristband regularly during the three months of the intervention. Versions 7 and 8 of the Xiaomi Smart Band activity wristband allow the recording and monitoring of health-related variables: physical activity, sleep, heart rate, blood oxygen saturation (SpO₂), women's health, and stress.
The wristband will be synchronized with the TechQoL4Carers platform to monitor physical activity: number of steps, distance in meters, and activity in minutes.
Measured: 3 months wearing the Xiaomi Smart Band
Change in sleep measured by the Xiaomi Smart Band during intervention
In the study, participants will use the Xiaomi Smart Band activity wristband regularly during the three months of the intervention. Versions 7 and 8 of the Xiaomi Smart Band activity wristband allow the recording and monitoring of health-related variables: physical activity, sleep, heart rate, blood oxygen saturation (SpO₂), women's health, and stress.
The wristband will be synchronized with the TechQoL4Carers platform to monitor sleep: light sleep, deep sleep, REM sleep, and time awake after sleep onset in minutes.
Measured: 3 months wearing the Xiaomi Smart Band
Change in daily functioning measured by TechQoL4Carers platform during the intervention
The TechQoL4Carers platform allows the self-administration of a weekly questionnaire designed by the research team to identify changes perceived by the person in daily functioning based on the variables studied: quality of life, satisfaction with the care, occupational balance, self-management of health, and empowerment.
The development of this questionnaire has been based on previous surveys developed by the research team, but it has been adapted to caregivers for this study.
The TechQoL4Carers weekly questionnaire is integrated with nine items that are answered using a six-point Likert scale, ranging from 0 (completely disagree) to 5 (completely agree). Score range: 0 to 45 points. Score interpretation: The higher the score, the greater the perception of positive changes in quality of life-related factors.
Measured: Once a week during the intervention (three months)
TechQoL4Carers Satisfaction Questionnaire
The TechQoL4Carers Satisfaction Questionnaire will be administered at the end of the intervention to assess end-user satisfaction with the project and the technology. The questionnaire has been adapted for this study based on the Technology Satisfaction Factor Loadings questionnaire (Njoroge et al., 2012).
It is a self-administered questionnaire consisting of 16 items grouped into four factors (proficiency, assessment, performance, and TechQoL4Carers platform), rated on a six-point scale, ranging from 0 (completely disagree) to 5 (completely agree). Score range: 0 to 80. Score interpretation: The higher the agreement with the statements, the higher the satisfaction with the project.
Measured: One month post-intervention
Meaning attributed to participation in the project
At the end of the project, a semi-structured individual interview will be conducted with each caregiver. The interview guide has been designed to elicit the meaning that the caregivers give to the caregiving experience, to the participation in the project, to the use of technology in the project, and the impact of this project on their daily life (quality of life, impact of caregiving, occupational balance, self-management of health and empowerment).
This interview will take place in the collaborating entities, in a quiet and comfortable place, and at a time that suits the needs of the participants. It will be recorded with a digital device to facilitate the literal transcription. This information will be coded and at the end of the study, the transcriptions will be anonymized and the audios will be deleted.
Measured: One month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 May 2024
- Primary completion17 Mar 2025
- Study completion24 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Informal CaregiversStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade da Coruña
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Innovation, Spain, Center on Information and Communication Technologies
- Responsible party
- Principal investigator, Betania Groba González, Universidade da Coruña
- Investigators
- Betania Groba, PhD, Principal investigator, Universidade da CoruñaLaura Nieto-Riveiro, PhD, Principal investigator, Universidade da CoruñaJavier Pereira, PhD, Study chair, Universidade da Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226285
- Sponsor's protocol ID
- 2023_019
- Acronym
- TechQoL4Carers
- Status last verified
- Mar 2025
- First submitted
- 3 Jan 2024
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be available for sharing with the scientific community, upon request and after the acceptance for publication of the main findings from de final data set. The data will be completely anonymized for sharing. The dataset will include only the results of quantitative variables. An institutional data use agreement will be required before data is shared. The microdata will also be transferred to the specific Social Studies Data Bank of the Spanish Sociological Research Center.
Publications
Bretones FD, Jáimez MJ. Spanish adaptation and validation of the Psychological Empowerment Scale. Interdisciplinaria. 2022; 39(1): 195-210. https://doi.org/10.16888/INTERD.2022.39.1.12
Brouwer WB, van Exel NJ, van Gorp B, Redekop WK. The CarerQol instrument: a new instrument to measure care-related quality of life of informal caregivers for use in economic evaluations. Qual Life Res. 2006 Aug;15(6):1005-21. doi: 10.1007/s11136-005-5994-6.
PubMed 16900281Concheiro-Moscoso P, Groba B, Martinez-Martinez FJ, Miranda-Duro MDC, Nieto-Riveiro L, Pousada T, Queiros C, Pereira J. Study for the Design of a Protocol to Assess the Impact of Stress in the Quality of Life of Workers. Int J Environ Res Public Health. 2021 Feb 3;18(4):1413. doi: 10.3390/ijerph18041413.
PubMed 33546392Concheiro-Moscoso P, Groba B, Martinez-Martinez FJ, Miranda-Duro MDC, Nieto-Riveiro L, Pousada T, Pereira J. Use of the Xiaomi Mi Band for sleep monitoring and its influence on the daily life of older people living in a nursing home. Digit Health. 2022 Aug 29;8:20552076221121162. doi: 10.1177/20552076221121162. eCollection 2022 Jan-Dec.
PubMed 36060611EuroQol Research Foundation. EQ-5D-5L User Guide Basic information on how to use the EQ-5D-5L instrument. 2019. https://euroqol.org/publications/user-guides/
Hernandez G, Garin O, Pardo Y, Vilagut G, Pont A, Suarez M, Neira M, Rajmil L, Gorostiza I, Ramallo-Farina Y, Cabases J, Alonso J, Ferrer M. Validity of the EQ-5D-5L and reference norms for the Spanish population. Qual Life Res. 2018 Sep;27(9):2337-2348. doi: 10.1007/s11136-018-1877-5. Epub 2018 May 16.
PubMed 29767329López AS, Moral SM. Validación del Índice de Esfuerzo del Cuidador en la población española [Validation of the Caregiver Strain Index in Spanish population]. Enferm Comunitaria. 2005; 1(1): 12-17.
Martín-Carrasco M, Salvadó I, Nadal Álava S, Miji LC, Rico JM, Lanz P, Taussig MI. Adaptación para nuestro medio de la escala de sobrecarga del cuidador (Caregiver Burden Interview) de Zarit. Revista de Gerontología. 1996; 6(4): 338-346.
Martin-Carrasco M, Otermin P, Perez-Camo V, Pujol J, Aguera L, Martin MJ, Gobartt AL, Pons S, Balana M. EDUCA study: Psychometric properties of the Spanish version of the Zarit Caregiver Burden Scale. Aging Ment Health. 2010 Aug;14(6):705-11. doi: 10.1080/13607860903586094.
PubMed 20544413Miranda-Duro MDC, Nieto-Riveiro L, Concheiro-Moscoso P, Groba B, Pousada T, Canosa N, Pereira J. Analysis of Older Adults in Spanish Care Facilities, Risk of Falling and Daily Activity Using Xiaomi Mi Band 2. Sensors (Basel). 2021 May 11;21(10):3341. doi: 10.3390/s21103341.
PubMed 34064993Njoroge J, Norman A, Reed D, Suh I. Identifying Facets of Technology Satisfaction: Measure Development and Application. J Learn High Educ. 2012; 1(2): 7-17. https://eric.ed.gov/?id=EJ1145014
Odriozola Gojenola M, Vita Garay A, Maiz Alkorta B, Zialtzeta Aduriz L, Bengoetxea Gallastegi L. Índice de esfuerzo del cuidador: test diagnóstico de sobrecarga en cuidadores de enfermos con demencia. Semer - Med Fam. 2008; 34(9): 435-438. https://doi.org/10.1016/S1138-3593(08)75201-8
Peral-Gomez P, Lopez-Roig S, Pastor-Mira MA, Abad-Navarro E, Valera-Gran D, Hakansson C, Wagman P. Cultural Adaptation and Psychometric Properties of the Spanish Version of the Occupational Balance Questionnaire: An Instrument for Occupation-Based Research. Int J Environ Res Public Health. 2021 Jul 14;18(14):7506. doi: 10.3390/ijerph18147506.
PubMed 34299957Ramos-Goni JM, Craig BM, Oppe M, Ramallo-Farina Y, Pinto-Prades JL, Luo N, Rivero-Arias O. Handling Data Quality Issues to Estimate the Spanish EQ-5D-5L Value Set Using a Hybrid Interval Regression Approach. Value Health. 2018 May;21(5):596-604. doi: 10.1016/j.jval.2017.10.023. Epub 2017 Dec 2.
PubMed 29753358Robinson BC. Validation of a Caregiver Strain Index. J Gerontol. 1983 May;38(3):344-8. doi: 10.1093/geronj/38.3.344.
PubMed 6841931
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life for Carers Through a Person-Centred Technological Solution
- ClinicalTrials.gov ID
- NCT06226285
- Acronym / sponsor ID
- TechQoL4Carers / 2023_019
- Keywords
- Quality of Life, informal caregivers, innovation, technological solution, wearable devices, occupational balance, self-management of health, empowerment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Universidade da CoruñaUniversity, hospital or other
- Collaborators
- Ministry of Science and Innovation, Spain, Center on Information and Communication Technologies
- Study start
- 1 May 2024 (actual)
- Primary completion
- 17 Mar 2025 (actual)
- Study completion
- 24 Mar 2025 (actual)
- First posted
- 26 Jan 2024 (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.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Informal caregivers | Experimental | Device: TechQoL4Carers PlatformInformal 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| TechQoL4Carers PlatformThe 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. | Device | Informal caregivers |
Primary outcome
Change in health-related Quality of Life from baseline to post-intervention
Time frame: Pre-Post: baseline and one-month 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).
Change in overall health from baseline to post-intervention
Time frame: Pre-Post: baseline and one-month 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).
Change in care-related QoL from baseline to post-intervention
Time frame: Pre-Post: baseline and one-month 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.
Change in perceived well-being from baseline to post-intervention
Time frame: Pre-Post: baseline and one-month 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.
9 secondary outcomes
Change in caregiver burden from baseline to post-intervention
Time frame: Pre-Post: baseline and one-month post-intervention
Change in caregiver strain from baseline to post-intervention
Time frame: Pre-Post: baseline and one-month post-intervention
Change in occupational balance from baseline to post-intervention
Time frame: Pre-Post: baseline and one-month post-intervention
Change in perceived empowerment from baseline to post-intervention
Time frame: Pre-Post: baseline and one-month post-intervention
Change in physical activity measured by the Xiaomi Smart Band during intervention
Time frame: 3 months wearing the Xiaomi Smart Band
Change in sleep measured by the Xiaomi Smart Band during intervention
Time frame: 3 months wearing the Xiaomi Smart Band
Change in daily functioning measured by TechQoL4Carers platform during the intervention
Time frame: Once a week during the intervention (three months)
TechQoL4Carers Satisfaction Questionnaire
Time frame: One month post-intervention
Meaning attributed to participation in the project
Time frame: One month post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- BackgroundBretones FD, Jáimez MJ. Spanish adaptation and validation of the Psychological Empowerment Scale. Interdisciplinaria. 2022; 39(1): 195-210. https://doi.org/10.16888/INTERD.2022.39.1.12
- Background: PubMed 16900281Brouwer WB, van Exel NJ, van Gorp B, Redekop WK. The CarerQol instrument: a new instrument to measure care-related quality of life of informal caregivers for use in economic evaluations. Qual Life Res. 2006 Aug;15(6):1005-21. doi: 10.1007/s11136-005-5994-6.
- Background: PubMed 33546392Concheiro-Moscoso P, Groba B, Martinez-Martinez FJ, Miranda-Duro MDC, Nieto-Riveiro L, Pousada T, Queiros C, Pereira J. Study for the Design of a Protocol to Assess the Impact of Stress in the Quality of Life of Workers. Int J Environ Res Public Health. 2021 Feb 3;18(4):1413. doi: 10.3390/ijerph18041413.
- Background: PubMed 36060611Concheiro-Moscoso P, Groba B, Martinez-Martinez FJ, Miranda-Duro MDC, Nieto-Riveiro L, Pousada T, Pereira J. Use of the Xiaomi Mi Band for sleep monitoring and its influence on the daily life of older people living in a nursing home. Digit Health. 2022 Aug 29;8:20552076221121162. doi: 10.1177/20552076221121162. eCollection 2022 Jan-Dec.
- BackgroundEuroQol Research Foundation. EQ-5D-5L User Guide Basic information on how to use the EQ-5D-5L instrument. 2019. https://euroqol.org/publications/user-guides/
- Background: PubMed 29767329Hernandez G, Garin O, Pardo Y, Vilagut G, Pont A, Suarez M, Neira M, Rajmil L, Gorostiza I, Ramallo-Farina Y, Cabases J, Alonso J, Ferrer M. Validity of the EQ-5D-5L and reference norms for the Spanish population. Qual Life Res. 2018 Sep;27(9):2337-2348. doi: 10.1007/s11136-018-1877-5. Epub 2018 May 16.
- BackgroundLópez AS, Moral SM. Validación del Índice de Esfuerzo del Cuidador en la población española [Validation of the Caregiver Strain Index in Spanish population]. Enferm Comunitaria. 2005; 1(1): 12-17.
- BackgroundMartín-Carrasco M, Salvadó I, Nadal Álava S, Miji LC, Rico JM, Lanz P, Taussig MI. Adaptación para nuestro medio de la escala de sobrecarga del cuidador (Caregiver Burden Interview) de Zarit. Revista de Gerontología. 1996; 6(4): 338-346.
- Background: PubMed 20544413Martin-Carrasco M, Otermin P, Perez-Camo V, Pujol J, Aguera L, Martin MJ, Gobartt AL, Pons S, Balana M. EDUCA study: Psychometric properties of the Spanish version of the Zarit Caregiver Burden Scale. Aging Ment Health. 2010 Aug;14(6):705-11. doi: 10.1080/13607860903586094.
- Background: PubMed 34064993Miranda-Duro MDC, Nieto-Riveiro L, Concheiro-Moscoso P, Groba B, Pousada T, Canosa N, Pereira J. Analysis of Older Adults in Spanish Care Facilities, Risk of Falling and Daily Activity Using Xiaomi Mi Band 2. Sensors (Basel). 2021 May 11;21(10):3341. doi: 10.3390/s21103341.
- BackgroundNjoroge J, Norman A, Reed D, Suh I. Identifying Facets of Technology Satisfaction: Measure Development and Application. J Learn High Educ. 2012; 1(2): 7-17. https://eric.ed.gov/?id=EJ1145014
- BackgroundOdriozola Gojenola M, Vita Garay A, Maiz Alkorta B, Zialtzeta Aduriz L, Bengoetxea Gallastegi L. Índice de esfuerzo del cuidador: test diagnóstico de sobrecarga en cuidadores de enfermos con demencia. Semer - Med Fam. 2008; 34(9): 435-438. https://doi.org/10.1016/S1138-3593(08)75201-8
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be available for sharing with the scientific community, upon request and after the acceptance for publication of the main findings from de final data set. The data will be completely anonymized for sharing. The dataset will include only the results of quantitative variables. An institutional data use agreement will be required before data is shared. The microdata will also be transferred to the specific Social Studies Data Bank of the Spanish Sociological Research Center.
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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. This study is not recruiting at the moment.
Betania Groba, PhD principal investigator
Universidade da Coruña
Laura Nieto-Riveiro, PhD principal investigator
Universidade da Coruña
Javier Pereira, PhD study chair
Universidade da Coruña
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TechQoL4Carers Platform in people with Informal Caregivers and Quality of Life, run by Universidade da Coruña 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 27 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in health-related Quality of Life from baseline to post-intervention (time frame: Pre-Post: baseline and one-month post-intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06226285, which also lists 25 linked publications.
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 27 Mar 2025.