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Health-Related Quality-of-LifeCAIRNCT07237971

Cocreating Action to Improve Rationality in the Health System

A study testing Cocreation process in people with Health-Related Quality-of-Life and Social Capital, run by Universidad Miguel Hernandez de Elche at 2 sites in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Despite widespread recognition of social, economic, or environmental health determinants, health action remains heavily dominated by individual-level solutions (e.g., medication, patient counselling, vaccination). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Cocreation process
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,000 participants
Where
2 sitesSpain
Study dates
21 Oct 2025to 1 Apr 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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

Survey general population:

A representative population survey of adult (aged 18 years and over) who are residents in the Municipal District 2 of Elche (Spain).

Survey community pharmacies:

Individuals who visit the pharmacies collaborating in the Municipal District 2 of Elche (Spain) to obtain any of the medications, aged 18 years and over for three a priori established medication groups.

  • Group 1 (Antidepressants and Anxiolytics): N05B, N05C, N06A.
  • Group 2 (Cardiovascular disease risk factor medication): A10B (antidiabetics), C10A (cholesterol-lowering drugs), C07A, C09A, C03C, C08C (antihypertensives).
  • Group 3 (Antibiotics): J01

Health service data from primary care:

A series of aggregate indicators will be collected from the electronic information systems of the regional health authorities (Conselleria de Sanidad de la Generalitat Valenciana), which hosts information on both prescriptions made by physicians and those dispensed in the community pharmacies of the Valencian Community. These indicators will be calculated for individuals aged 18 years and over for groups 2 and 3, and 12 years and over for group 1 using aggregate data from health system's registries and, therefore, not considering 12 years old as minimum age limit of the eligible participants in the present study protocol registry. Furthermore, aggregate data about the number of consultations will be collected in the two primary care facilities in the study area for individuals aged 18 and over.

Qualitative methods and cocreation procedure:

Focus groups, sociograms and in-depth interviews will include 6-8 participants and last approximately 90 minutes. Participation in the co-creation process will be open, voluntary, and will depend on the interest of individuals and entities in the area. Eligibility criteria:

  • People aged 18 and over who are residents or have a job or family connection in the Municipal District 2 of Elche (Spain) who are interested in participating, wish to be actively involved in the co-creation, planning, and implementation of community initiatives, and are available to attend the conferences, meetings, and workshops.
  • Representatives from community institutions and associations, including professionals from the Elche Public Health Center, primary care teams in the area, Elche Council staff, as well as professionals and volunteers from NGOs and other local organizations with experience in community work in the district.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Lucy A Parker, PhD contact

(0034)965919516

cair@umh.es

Spain2 sites, 2 recruiting

  • Community

    Elche, Alicante, 03206

    Recruiting

  • Community based. Municipal District 2 of Elche

    Elche, Alicante

    Lucy A Parker, PhD, (0034)965919516, cair@umh.es

    Recruiting

Other trials in Spain

About this study

Despite widespread recognition of social, economic, or environmental health determinants, health action remains heavily dominated by individual-level solutions (e.g., medication, patient counselling, vaccination). This study aims to stimulate changes in health system functioning by demonstrating how the cocreation of actions to address psychological well-being, cardiovascular health, and antimicrobial resistance from within the community can alleviate the burden on primary care services, reduce medicalisation and increase health equity.

The scientific approach uses mixed methods and incorporates theory from multiple disciplines. This study will appraise how the current system addresses psychological well-being, cardiovascular (CV) health, and rational use of antibiotics using a population survey, a survey of patients collecting their medication at community pharmacies, aggregate health service indicators on medication consumption and primary care consultations, and qualitative methods exploring stakeholders' perceptions.The investigators will undertake community-based participatory research to engage citizen scientists in the cocreation of community-led actions to promote psychological well-being, CV health, and prevent antimicrobial resistance. The design, implementation, and evaluation of the actions will apply an assets-based approach and apply theories and frameworks from implementation science in an iterative manner over 3 years. Finally, the impact of the cocreated actions will be analysed, considering effectiveness and broader contextual issues such as initiative adoption, implementation, and maintenance. The investigators will use a before-after comparison of survey indicators, an interrupted time-series analysis of health service data and qualitative analysis.

The goal is to demonstrate how the integration of community action with attention to the social determinants of health, can lead to a more rational approach to health care and ultimately improve health and health equity.

Read the detailed description

This study seeks to cocreate actions that address three major health issues within the community to reduce medicalisation and help unburden primary healthcare services. The first issue is related to psychological well-being and the overuse of anxiolytics and antidepressants. Mental health problems are one of the greatest public health challenges in the European Region, affecting about 25% of the population every year and some estimates place Spain, where this research takes place, as the highest per-capita consumer of anxiolytic medication in the world. The second issue relates to addressing CV health and over-reliance on medication to treat CV risk factors as "pre-diseases". While CV disease continues to be the leading cause of adult mortality worldwide, there is a rise in overdiagnosis and overtreatment of CV risk factors in primary care and limited CV health promotion at community level. The third issue is to promote rational use of antibiotics and reduce the risk of antimicrobial resistance, an issue considered to be in the top 10 global public health threats today.

As the title of this study suggests, the investigators question whether the current approach to these important public health issues is truly rational. Health action remains heavily dominated by individual-level solutions (e.g., medication, patient counselling, vaccination) despite widespread recognition of the social, economic, or environmental factors that determine health. Health professionals frequently acknowledge the importance and potential of non-pharmacological community-based interventions, yet barriers exist to put them into practice. Even the way that the public health system is conceptualised leads to overemphasize the importance of the health services as the accountable component for providing health and well-being. In fact, there are numerous organizations and individuals who develop actions in areas that are not directly recognizable as part of the health system (e.g., senior citizens clubs, urban planners, cultural centres), but which greatly facilitate the effectiveness of the system and have the potential to produce significant health and wellbeing benefits. The project will apply a "systems thinking" approach and consider that any organization, person, or action that influences the physical or social environment has the potential to influence health and wellbeing, and thus could be considered part of the public health system if they are incorporated into the decision-making domains that have a primary desire or interest in maximizing health. Important, yet frequently underestimated, health systems components are found in the community.

Identifying and activating health promoting resources in the community is a legitimate and effective way to improve health and health equity. It forms the basis of a substantial body of research and practice on health promotion with community assets. A community can also be characterised and described by its level of social capital, which in itself is a key component of community resources, as well as a determinant of physical and mental health. It includes the perceptions that people have about the level of interpersonal trust, exchange and reciprocity in their community, as well as the density of their social networks and patterns of civic engagement. This study put forward an ambitious plan to show how the power of the community and its members can be harnessed to cocreate actions that move them from a predominant biomedical vision to a truly rational health system.

Engaging the community in research or practice is acknowledged as a powerful tool to elicit meaningful and sustainable change. Furthermore, it is an effective way to reduce inequity. In this line, increasing attention is centred on developing citizen science initiatives that move beyond engaging citizens in data collection, and towards citizens having a meaningful input in all phases of the research, including design and translation of the findings into practice. The community-based participatory research model has proven useful in this endeavour. This study considers here that deep community engagement in research can improve critical health literacy (CHL), not just among the citizen scientists but among the community as a whole. CHL refers to individuals or communities that are able to critically appraise information, understand the social determinants of health and have skills oriented towards collective social and political action. The issue is paramount to the problem addressed here as CHL is widely assumed to lead to a more effective and efficient use of health services. In light of these considerations, the research proposed seeks to foster the complexity and dynamism of the health system by integrating community action and attention to the social determinants of health. This will refocus how psychological wellbeing, CV health, and antimicrobial resistance are approached. Together with citizen scientists the investigators will cocreate community actions in each of these 3 areas and will show how they can ultimately impact health and health equity. The objectives are:

Overall objective: To determine the impact on health and health equity of a series of cocreated actions to improve rationality in the health system.

Specific objectives:

  1. To generate rigorous quantitative and qualitative epidemiological data on the current health systems approach to address psychological wellbeing, CV health, and antimicrobial resistance.
  2. To cocreate actions to promote psychological wellbeing, CV health, and rational use of antibiotics with a community approach.
  3. To assess the impact of the cocreated actions on health and health equity at local population level.
Being tested
Cocreation process
Keywords
Community health, Cocreation action, Health system, Health literacy, Social capital, Community capital, Antibiotic drug use, Cardiovascular drug use, Psychotropic drug use, Health-related quality of life, Health equity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cocreation processOther

    Also called Community-based participatory research (CBPR)

    The cocreation process will involve various advisory and participatory bodies to ensure the active involvement of the community and local institutions, also with the research team, ensuring that actions respond to collective needs of the community. Recruitment of these advisory and participatory bodies will be carried out through a participatory strategy involving the Basic Health Councils of the healthcare centers in the area, as well as other associations, religious institutions, and local leaders. Based on previous sociograms, strategic locations will be identified for organizing informational meetings in accessible places in the area, such as community centers. Dissemination will be carried out through social media, posters, and other inclusive means to ensure the participation of vulnerable groups. Participation in the cocreation process will be open, voluntary, and will depend on the interest of individuals and entities in the area.

Study groups in NCT07237971
Study groupRoleWhat they receive
Cocreating process to improve rationality in the health system in a deprived neighborhoodExperimentalNot described
Receives: Other: Cocreation process

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Health-related quality of life

    Health-related quality of life will be measured using the VR-12 questionnaire, which was internationally validated (Selim et al., 2022). The VR-12 questionnaire contains 12 items that assess eight aspects of health-related quality of life: physical dimension, mental dimension, physical function, physical role, bodily pain, general health, vitality, emotional role, social function, and mental health. The instrument measures eight scales that are used to produce a summary score in two different dimensions: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).

    Measured: 5 years

  2. Medical drug consumption

    Aggregated data of Primary Care for the studied Basic Health Zones (BHZ):

    • Defined Daily Dose (DDD) per 1,000 inhabitants per day of drugs in classes N05B, N05C, and N06A prescribed to people over 12 years of age by an SNS professional in each basic health zone (BHZ).
    • DDD of drugs of classes N05B, N05C, and N06A that have been prescribed to persons over 12 years in each BHZ and are subsequently dispensed in a community pharmacy.
    • DDD of drugs of classes A10B, C10A, C07A, C09A, C03C, C08C prescribed to persons over 15 years in each BHZ.
    • DDD of drugs of classes A10B, C10A, C07A, C09A, C03C, C08C that have been prescribed to people over 15 years in each BHZ and are subsequently dispensed in a community pharmacy.
    • DDD of drugs of classes J01 prescribed to people over 15 years in each BHZ.
    • DDD of drugs of classes J01 that have been prescribed in each BHZ and are subsequently dispensed in a community pharmacy.

    Measured: 5 years

  3. Workload in primary healthcare

    The number of consultations carried out in each studied Basic Health Zone will be retrieved for people over 15 years, disaggregated by the reason for consultation. This indicator will be calculated monthly during the five years of the study and disaggregated by relevant sociodemographic characteristics. Similarly, the average number of medications per clinical encounter will be calculated by dividing the total number of prescriptions in each period by the total number of consultations. Similarly, at six-month intervals, the percentage of clinical encounters that result in the prescription of antibiotics will be computed.

    Measured: 5 years

Secondary outcomes (10)

  1. Critical Health literacy

    Different domains of health literacy include basic functional health literacy (the ability to access, understand, evaluate, and apply health information), communicative health literacy, and critical health literacy (Nutbeam, 2020). This study is particularly concerned with critical health literacy because it involves the critical evaluation of information, understanding the social determinants of health, and is linked to collective action (Chinn, 2011). Furthermore, it is widely assumed that better critical health literacy leads to more effective and efficient use of services (Sykes et al., 2013). These aspects will be measured using the All Aspects of Health Literacy Scale (Chinn \& McCarthy, 2013) after analyzing the psychometric properties of a new version adapted to Spain scoring between 1 (lowest health literacy) and 43 (highest health literacy).

    Measured: 5 years

  2. Social capital and community belonging

    A measure related to social capital will be included, given that it is a key determinant of physical and mental health (Kawachi et al., 1999; Stoyanova \& Díaz-Serrano, 2009; Villalonga-Olives \& Kawachi, 2015). This study will develop a questionnaire based on a scale previously validated in the United States for Latino population (Villalonga-Olives et al., 2016). This study will focus on trust in close friends and family to cope with difficult times (e.g., the possibility of receiving financial help in times of need or having someone to care for children in an emergency) and community belonging, also including a domain of social cohesion from the Canadian Community Health Survey. Social capital will score between 0 (lowest social capital) and 10 (highest social capital), social cohesion between 8 (lowest cohesion) and 33 (highest cohesion), and community belonging between 6 (lowest belonging) and 24 (highest belonging).

    Measured: 5 years

  3. Community capital

    An ad-hoc tool will be developed to measure the use of community assets, here defined as "any factor (or resource) that enhances the capacity of individuals, groups, communities, populations, social systems and institutions to maintain and sustain health and well-being and helps them to reduce health inequalities", as well as potential barriers to their use. The tool will contain questions on community assets, classified into seven categories: 1. Natural, 2. Cultural, 3. Human, 4. Social, 5. Political, 6. Financial and 7. Built. Participants will be asked if they consider that their environment (this includes the neighbourhood where they live, and other places in the municipality that they frequent) has these community assets and how often they use them. The ad-hoc instrument will be pre-tested with a small representative sample of the community to obtain feedback on the clarity and relevance of the questions in order to make any necessary adjustments before its final implementation.

    Measured: 5 years

  4. Knowledge, attitudes and practices on personal antibiotic use

    Knowledge, attitudes and practices on personal antibiotic use will be measured using an instrument validated in Spain. This instrument will obtain data to analyse common antibiotic-related behaviours of the following three dimensions: knowledge (what respondents know about antibiotics), attitude (what respondents think about antibiotics) and practice (what they do regarding antibiotics). The different domains will be measured in a Likert scale from 0 to 10 with a final score between 0 (lowest knowledge, attitudes and practices on personal antibiotic use) and 160 (highest knowledge, attitudes and practices).

    Measured: 5 years

  5. Mental health literacy

    The investigators will use the brief mental health literacy questionnaire for adults by Campos et al. (2022). For its validation in Spain, this study will carry out its translation and cultural adaptation through direct translation, expert review, back-translation, and semantic adjustments. This study will then validate its content through consultation with mental health specialists to assess the clarity and relevance of the items. A pilot test will be carried out on a small sample of participants who visit the community pharmacy to detect possible comprehension problems. Moreover, psychometric validation will be carried out with a representative sample, evaluating internal consistency (Cronbach's alpha), construct validity (factor analysis), and test-retest reliability. Mental health literacy will be measured using a Likert scale from 1 to 5, with a final score between 16 (lowest mental health literacy) and 80 (highest mental health literacy).

    Measured: 5 years

  6. Use and barriers to non-pharmacological interventions

    The investigators will present a list of non-pharmacological interventions for the patients to select if some of them have been offered by their clinicians, family members, friends or other means. Furthermore they will report on perceived barriers to following non-pharmacological interventions. The questionnaire tool will be developed and validated.

    Measured: 5 years

  7. Knowledge about behaviours and cardiovascular risk

    The level of knowledge and attitude toward behaviours related to CV health and risk will be assessed using the questionnaire validated in Spain. The questionnaire is scored using a 5-point Likert scale, where 1 represents the least correct answer and 5 the most correct, with a minimum score of 24 (lowest level of knowledge) maximum score of 120 (highest level of knowledge) points for the 24 items. A score above 90 indicates a high level of knowledge (at least 75% correct answers).

    Measured: 5 years

  8. Antibiotic appropriateness

    To assess antibiotic appropriateness, we will use the TARGET antibiotic checklist, included in the TARGET antibiotic toolkit ("treating antibiotics responsibly; guidance, education and tools") developed by the UK Royal College of General Practitioners in 2022.

    Measured: 5 years

  9. Medication knowledge

    Patients' knowledge of their medications will be assessed, including aspects such as indication, duration of treatment, method of administration, and possible adverse effects, using a questionnaire validated in Spain. This questionnaire will be applied to a single medication per participant in the pharmacy survey. It is assumed that in a more rational healthcare system, people take fewer medications as a more appropriate and justified use of treatments. At the same time, those who do need medication may have greater knowledge about it, given that in a more efficient system there is better health literacy and patients have more time with their healthcare professional to receive detailed explanations about their treatment.

    Measured: 5 years

  10. Indicators of the National Antibiotic Resistance Plan

    The Spanish National Antibiotic Resistance Plan includes a selection of indicators for analysing antimicrobial consumption in primary care. These indicators are designed to measure both consumption rates and exposure to antibiotics among the population and to analyse the selection of certain groups of antibiotics.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2025
  2. Study start21 Oct 2025
  3. Primary completion1 Apr 2029 (estimated)
  4. Study completion1 Apr 2029 (estimated)

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Model description
A community-based participatory research will be conducted to engage citizen scientists in the cocreation of community-led actions to promote psychological well-being, CV health, and prevent antimicrobial resistance. The design, implementation, and evaluation of the actions will apply an assets-based approach in an iterative manner over 3 years. The investigators will use some preliminary results from a population survey, a survey of patients collecting their medication at community pharmacies, aggregate health service indicators on medication consumption and primary care consultations, and qualitative methods (sociograms, interviews, and focus groups) to boost the cocreation process. Finally, the impact of the cocreated actions will analysed. This study will use a before-after comparison of survey indicators, an interrupted time-series analysis of health service data and qualitative analysis.
Masking
None (open label)
Enrolment
4,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07237971
Sponsor's protocol ID
Grant No. 101125843
Other IDs
ERC-2023-COG 101125843
Acronym
CAIR
Status last verified
Nov 2025
First submitted
14 Nov 2025
Last updated
2 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The datasets generated by the CAIR project will be archived in the data repository Zenodo and will be linked on the project's website https://www.cairproject.eu/. Metadata from Zenodo (title, description, keywords, creation date, creators, license, and format) will be used for dataset description and discovery. DOIs will be assigned to datasets published in this repository to ensure unique citation, while Zenodo will provide secure storage for our (meta)data and allow us different licenses and access levels. The DOI of (meta)data will be included in relevant publications, making it easy to locate the anonymized raw data. The more public-facing content will also be disseminated through the project's associated social media channels as Facebook (CAIR Project), Bluesky (@erc.europa.eu), and Instagram (cairproject.eu)).

Publications

  • Campos L, Dias P, Costa M, Rabin L, Miles R, Lestari S, Feraihan R, Pant N, Sriwichai N, Boonchieng W, Yu L. Mental health literacy questionnaire-short version for adults (MHLq-SVa): validation study in China, India, Indonesia, Portugal, Thailand, and the United States. BMC Psychiatry. 2022 Nov 16;22(1):713. doi: 10.1186/s12888-022-04308-0.

    PubMed 36384505

  • INCB. (n.d.). Report of the International Narcotics Control Board for 2021.

  • World Health Organization - Regional Office for Europe. (2015). The European Mental Health Action Plan 2013-2020. World Health Organization, 19.

  • Roth GA, Mensah GA, Johnson CO, Addolorato G, Ammirati E, Baddour LM, Barengo NC, Beaton AZ, Benjamin EJ, Benziger CP, Bonny A, Brauer M, Brodmann M, Cahill TJ, Carapetis J, Catapano AL, Chugh SS, Cooper LT, Coresh J, Criqui M, DeCleene N, Eagle KA, Emmons-Bell S, Feigin VL, Fernandez-Sola J, Fowkes G, Gakidou E, Grundy SM, He FJ, Howard G, Hu F, Inker L, Karthikeyan G, Kassebaum N, Koroshetz W, Lavie C, Lloyd-Jones D, Lu HS, Mirijello A, Temesgen AM, Mokdad A, Moran AE, Muntner P, Narula J, Neal B, Ntsekhe M, Moraes de Oliveira G, Otto C, Owolabi M, Pratt M, Rajagopalan S, Reitsma M, Ribeiro ALP, Rigotti N, Rodgers A, Sable C, Shakil S, Sliwa-Hahnle K, Stark B, Sundstrom J, Timpel P, Tleyjeh IM, Valgimigli M, Vos T, Whelton PK, Yacoub M, Zuhlke L, Murray C, Fuster V; GBD-NHLBI-JACC Global Burden of Cardiovascular Diseases Writing Group. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol. 2020 Dec 22;76(25):2982-3021. doi: 10.1016/j.jacc.2020.11.010.

    PubMed 33309175

  • Selim AJ, Rothendler JA, Qian SX, Bailey HM, Kazis LE. The History and Applications of the Veterans RAND 12-Item Health Survey (VR-12). J Ambul Care Manage. 2022 Jul-Sep 01;45(3):161-170. doi: 10.1097/JAC.0000000000000420.

    PubMed 35612387

  • Rosas LG, Rodriguez Espinosa P, Montes Jimenez F, King AC. The Role of Citizen Science in Promoting Health Equity. Annu Rev Public Health. 2022 Apr 5;43:215-234. doi: 10.1146/annurev-publhealth-090419-102856. Epub 2021 Nov 1.

    PubMed 34724389

  • Israel BA, Coombe CM, Cheezum RR, Schulz AJ, McGranaghan RJ, Lichtenstein R, Reyes AG, Clement J, Burris A. Community-based participatory research: a capacity-building approach for policy advocacy aimed at eliminating health disparities. Am J Public Health. 2010 Nov;100(11):2094-102. doi: 10.2105/AJPH.2009.170506. Epub 2010 Sep 23.

    PubMed 20864728

  • Chinn D. Critical health literacy: a review and critical analysis. Soc Sci Med. 2011 Jul;73(1):60-7. doi: 10.1016/j.socscimed.2011.04.004. Epub 2011 May 12.

    PubMed 21640456

  • Villalonga-Olives E, Adams I, Kawachi I. The development of a bridging social capital questionnaire for use in population health research. SSM Popul Health. 2016 Aug 31;2:613-622. doi: 10.1016/j.ssmph.2016.08.008. eCollection 2016 Dec.

    PubMed 29349175

  • Nutbeam, D. (2020). Health literacy as a public health goal: a challenge for contemporary health education and communication strategies into the 21st century. Health Promotion International, 15(3), 259-267.

  • Moreno-Llamas A, Navarro-Aranda N, Sanchis-Ramon MJ, Chilet-Rosell E, Lumbreras B, Blanes-Mira C, Lopez Pintor E, Hernandez-Aguado I, Parker LA. Assessing the impact of co-created community initiatives on health and equity: a protocol for population-based surveys within the CAIR project in Elche, Spain. Front Public Health. 2026 Jun 3;14:1766000. doi: 10.3389/fpubh.2026.1766000. eCollection 2026.

    PubMed 42317968

Questions about this trial

What is this clinical trial studying?

A study testing Cocreation process in people with Health-Related Quality-of-Life and Social Capital, run by Universidad Miguel Hernandez de Elche at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lucy A Parker, PhD ((0034)965919516, cair@umh.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health-related quality of life (time frame: 5 years). The study lists 3 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 NCT07237971, which also lists 11 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 2 Dec 2025.

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