Health, SubjectiveNCT03343886
Ageing and Health. Spanish Longitudinal Study
An observational study of Health, Subjective and Disability, Evaluation, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 3 sites in Spain.
Trial summary
Ageing with Health is a longitudinal cohort study aimed to examine trajectories of health, disability and wellbeing and their determinants for Spanish ageing population. The data that makes up the baseline was collected from a nationally representative sample of non-institutionalized adults as part of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health, Subjective, Disability, Evaluation, Chronic Disease
- How many people
- 7,755 participants
- Where
- 3 sitesSpain
- Study dates
- Jul 2011to Oct 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Study population: Community-living individuals in Spain aged 18 years or older
Who may be able to join
- Non-institutionalized Spanish residents
- 18 years and over
Who cannot join
- Institutionalized population
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Madrid, Madrid, 28006
Universidad Autónoma de Madrid
Madrid, Madrid, 28029
Fundació Sant Joan de Déu
Sant Boi de Llobregat, Barcelona, 08830
About this study
Official title: Ageing and Health. Spanish Longitudinal Study on Ageing, Physical and Mental Health, and Its Determinants
Ageing with Health is a longitudinal cohort study aimed to examine trajectories of health, disability and wellbeing and their determinants for Spanish ageing population. The data that makes up the baseline was collected from a nationally representative sample of non-institutionalized adults as part of the "Collaborative Research on Aging in Europe (COURAGE in Europe)" project between July 2011 and May 2012. The second wave was carried out as part of the "Age with Health" project between December 2014 and June 2015, and three years later, in 2018, the third wave was carried out. In 2019-2021, a new cohort of participants were brought in (2019 cohort), some of whom were interviewed again by telephone during the first Coronavirus (COVID-19) lockdown, in early 2020. In 2022, the fourth wave of the 2011 cohort was evaluated, and in 2023, the second wave of the 2019 cohort was evaluated. Finally, in 2025, the fifth wave of the 2011 cohort and the third wave of the 2019 cohort were evaluated, which are the last follow-ups in this study.
Read the detailed description
Study Design:
A prospective cohort general population study.
Sample:
Wave 1: A nationally representative sample of non-institutionalized adults aged 18 years or older from the Spanish population was collected (with an over-sampling of people aged 50+ years). A multi-stage clustered design was employed; four strata based on the number of inhabitants of the municipalities were built for each of the 17 Spanish autonomous communities. Clusters were selected within the strata with a probability of inclusion relative to their size. Within each cluster, households were randomly selected from a list of all households. In case there was more than one individual from the corresponding age group in the household, a random method was employed to select the individual participant.
Wave 2: Wave 1 sample was re-interviewed (Wave 2) in 2014-2015.
Wave 3: in 2018, participants were again evaluated. Complementarily, between 2019 and 2021 a new sample from the regions of Madrid and Barcelona were brought in, and it was interviewed again by telephone during the first COVID-19 lockdown, in May-June 2020.
Wave 4: a new evaluation of the participants of both cohorts 2011 and 2019 was carried out, in the fist case it terminated in 2022, while the data collection for 2019 cohort terminated in 2023.
Wave 5: the last follow-up of both cohorts was carried out in 2025.
Data collection:
Face-to-face interviews by Computer-Assisted Personal Interviewing at the respondents' homes by trained interviewers. All interviewers received a standardized training. Data quality control was also performed. A proxy interview was administered in those cases in which the participant presents physical or cognitive limitations that may impede the correct administration of the individual interview.
Main project objectives:
To assess trajectories of general health, disability and well-being in Spanish ageing population.
Secondary objectives:
To identify trajectories of healthy ageing (in terms of physical health, mental health, functioning and well-being) in Spanish adult population as well as their determinants To analyse prevalence and impact of chronic health conditions, mental health problems, well-being and loneliness on mortality in Spanish adult population.
To determine risk factors for incidence and persistence of mental and physical health problems in Spanish ageing population.
Main project hypotheses:
The trajectories of health, functioning and well-being will be encompassed by relevant environmental factors such as social support, loneliness and health care utilization, personal factors (socio-demographic characteristics, healthy lifestyles, and high cognitive reserve among others) and other biological and health-related factors (weight, height, waist circumference, executive functions, blood pressure, grip strength, vision acuity, presence of mental and physical health problems and quality of life).
- Conditions
- Health, Subjective, Disability, Evaluation, Chronic Disease, Mental Disorder, Aging, Loneliness
- Keywords
- Health Status, Well-being, Mental Health, Risk Factors, Aging
- Medical subject headings
- Chronic Disease, Mental Disorders, Cognitive Dysfunction, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 2011 | A nationally representative sample of 4753 non-institutionalized adults aged 18 years or older from the Spanish population was collected (with an over-sampling of people aged 50+ years). A multi-stage clustered design was employed. A total of 2528 individuals were re-interviewed in 2014. In 2018, 1577 were again evaluated. In 2022, 963 participants took part of another study's evaluation. The last follow-up of this cohort was conducted in 2025, when 595 participants were evaluated. | |
| Cohort 2019 | 3002 participants from the regions of Madrid and Barcelona were brought in between 2019 and 2021. The second wave of this cohort was conducted in 2023, and 1,116 participants were evaluated. This cohort was last evaluated in 2025, with 844 participants. In 2020, during the first Coronavirus (COVID-19) lockdown, 1166 of the participants from the first wave of the cohort were telephonically interviewed, a lateral sub-study evaluation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heath Status
Measure: Health composite total score. Construct: Health status. Final result: A global total score. Range: 0-100. 0 means lower health status.
Measured: Baseline
Disability
Measure: World Health Organization's Disability Assessment Schedule-II (WHODAS-II). Construct: Disability. Final result: A global total score. Range: 0-100. 0 means lower disability
Measured: Baseline
Experienced Well-being
Abbreviated Version of the Day Reconstruction Method. Construct: Experienced wellbeing.
Final Result: The used scale reports two global scores:
- Positive Affect total score. Range: 0-100 where 0 means lower positive affect.
- Negative Affect total score. Range 0-100 where 0 means lower negative affect.
Measured: Baseline
Quality of Life (WHOQOL-AGE)
Measure: World Health Organization Quality of Life-Age (WHOQOL-AGE) (Caballero, et al., 2013). Construct: Quality of life. Final Result: A global total score. Range 0-100. 0 means lower quality of life
Measured: Baseline
Secondary outcomes (6)
Number of Participants With Depression
Measure: The World Health Organization Composite International Diagnostic Interview (CIDI). Depression module (WHO-CIDI, 1990).
Construct: Presence of Depression. Final result: Two measures of depression according to Research Diagnostic Criteria.
- Presence of 12 month depression. Values (yes/no).
- Presence of lifetime depression. Values (yes/no).
Measured: Baseline
Presence of Suicide Behavior
Measure: The World Health Organization Composite International Diagnostic Interview (CIDI). Suicide module (WHO-CIDI, 1990).
Construct: Presence of Suicide behavior The instrument reports six measures of suicide behavior.
- Presence of 12 month suicide ideation. Values (yes/no)
- Presence of 12 month suicide planning. Values (yes/no)
- Presence of 12 month suicide attempts. Values (yes/no)
- Presence of lifetime suicide ideation. Values (yes/no)
- Presence of lifetime suicide planning. Values (yes/no)
- Presence of lifetime suicide attempts. Values (yes/no)
Measured: Baseline
Presence of Anxiety Disorders
Measure: The World Health Organization Composite International Diagnostic Interview (CIDI). Anxiety disorders module (WHO-CIDI, 1990).
Construct: Presence of anxiety Disorders Final Result: The instrument included in the study reports six measures of anxiety disorders according to Research diagnostic criteria.
- Presence of 12 month panic disorder. Values (yes/no)
- Presence of 12 month generalized anxiety disorder. Values (yes/no)
- Presence of 12 month phobic disorder. Values (yes/no)
- Presence of lifetime panic disorder. Values (yes/no)
- Presence of lifetime generalized anxiety disorder. Values (yes/no)
- Presence of lifetime phobic disorder. Values (yes/no)
Measured: Baseline
Presence of Diabetes
Construct: Presence of diabetes Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for diabetes Values: (Yes/No)
Measured: Baseline
Presence of Lung Disease
Construct: Presence of any lung disease Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for any lung disease Values: (Yes/No)
Measured: Baseline
Presence of Stroke
Construct: Presence of stroke Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for stroke Values: (Yes/No)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study startJul 2011
- Primary completionMay 2012
- Study completionOct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (63)Papers the sponsor has linked to this study.
- Other trials for Health, SubjectiveStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,755 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Sant Joan de Déu, Universidad Autonoma de Madrid, Centro de Investigación Biomédica en Red de Salud Mental
- Responsible party
- Sponsor
- Investigators
- Jose Luis Ayuso Mateos, MD, PhD, Principal investigator, Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaJosep Maria Haro, MD, PhD, Principal investigator, Fundació Sant Joan de Déu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343886
- Sponsor's protocol ID
- COURAGE2020
- Other IDs
- FP7/2007-2013- 316795, ACI2009-1010, PS09/00295, PS09/01845, PI12/01490, PI13/00059, PI16/01073, PI16/00812
- Status last verified
- Oct 2024
- First submitted
- 8 Nov 2017
- Last updated
- 29 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A sharing plan description has to be still agreed between the different Principal Investigators
Publications
Gabarrell-Pascuet A, Varga TV, Moneta MV, Ayuso-Mateos JL, Lara E, Olaya B, Haro JM, Domenech-Abella J. What factors explain the changes in major depressive disorder symptoms by age group during the COVID-19 pandemic? A longitudinal study. J Affect Disord. 2023 May 1;328:72-80. doi: 10.1016/j.jad.2023.02.042. Epub 2023 Feb 16.
PubMed 36806591Bayes-Marin I, Fernandez D, Lara E, Martin-Maria N, Miret M, Moreno-Agostino D, Ayuso-Mateos JL, Sanchez-Niubo A, Haro JM, Olaya B. Trajectories of Immediate and Delayed Verbal Memory in the Spanish General Population of Middle-aged and Older Adults. Brain Sci. 2020 Apr 22;10(4):249. doi: 10.3390/brainsci10040249.
PubMed 32331406Olaya B, Moneta MV, Lara E, Miret M, Martin-Maria N, Moreno-Agostino D, Ayuso-Mateos JL, Abduljabbar AS, Haro JM. Fruit and Vegetable Consumption and Potential Moderators Associated with All-Cause Mortality in a Representative Sample of Spanish Older Adults. Nutrients. 2019 Aug 2;11(8):1794. doi: 10.3390/nu11081794.
PubMed 31382535Moreno-Agostino, D., de la Torre-Luque, A., de la Fuente, J., Lara, E., Martín-María, N., Moneta, M. V., … & Ayuso-Mateos, J. L. (2020). Determinants of Subjective Wellbeing Trajectories in Older Adults: A Growth Mixture Modeling Approach. Journal of Happiness Studies, 1-18.
Martin-Maria N, Caballero FF, Miret M, Tyrovolas S, Haro JM, Ayuso-Mateos JL, Chatterji S. Differential impact of transient and chronic loneliness on health status. A longitudinal study. Psychol Health. 2020 Feb;35(2):177-195. doi: 10.1080/08870446.2019.1632312. Epub 2019 Jun 25.
PubMed 31237442Lara E, Moreno-Agostino D, Martin-Maria N, Miret M, Rico-Uribe LA, Olaya B, Cabello M, Haro JM, Ayuso-Mateos JL. Exploring the effect of loneliness on all-cause mortality: Are there differences between older adults and younger and middle-aged adults? Soc Sci Med. 2020 Aug;258:113087. doi: 10.1016/j.socscimed.2020.113087. Epub 2020 May 30.
PubMed 32554229Gayete S, Gine A, Miret M, Ayuso-Mateos JL, Haro JM, Olaya B. Cognitive function associated with different diagnoses of anxiety disorders over the lifespan: Results from a Spanish representative sample. J Anxiety Disord. 2020 Oct;75:102296. doi: 10.1016/j.janxdis.2020.102296. Epub 2020 Aug 20.
PubMed 32866758Martin-Maria N, Caballero FF, Lara E, Domenech-Abella J, Haro JM, Olaya B, Ayuso-Mateos JL, Miret M. Effects of transient and chronic loneliness on major depression in older adults: A longitudinal study. Int J Geriatr Psychiatry. 2021 Jan;36(1):76-85. doi: 10.1002/gps.5397. Epub 2020 Sep 10.
PubMed 32791563Garcia-Esquinas E, Ortola R, Gine-Vazquez I, Carnicero JA, Manas A, Lara E, Alvarez-Bustos A, Vicente-Rodriguez G, Sotos-Prieto M, Olaya B, Garcia-Garcia FJ, Gusi N, Banegas JR, Rodriguez-Gomez I, Struijk EA, Martinez-Gomez D, Lana A, Haro JM, Ayuso-Mateos JL, Rodriguez-Manas L, Ara I, Miret M, Rodriguez-Artalejo F. Changes in Health Behaviors, Mental and Physical Health among Older Adults under Severe Lockdown Restrictions during the COVID-19 Pandemic in Spain. Int J Environ Res Public Health. 2021 Jul 1;18(13):7067. doi: 10.3390/ijerph18137067.
PubMed 34281004Gabarrell-Pascuet A, Moneta MV, Ayuso-Mateos JL, Miret M, Lara E, Haro JM, Olaya B, Domenech-Abella J. The effect of loneliness and social support on the course of major depressive disorder among adults aged 50 years and older: A longitudinal study. Depress Anxiety. 2022 Feb;39(2):147-155. doi: 10.1002/da.23236. Epub 2022 Jan 14.
PubMed 35029840Rodeiro, J., Olaya, B., Haro, J. M., Gabarrell-Pascuet, A., Ayuso-Mateos, J. L., Francia, L., … & Domènech-Abella, J. (2025). The longitudinal relationship among physical activity, loneliness, and mental health in middle-aged and older adults: Results from the Edad con Salud cohort. Mental Health and Physical Activity, 100667.
Francia L, De Giorgi R, Lara E, Del Castellar BD, Castelletti C, Rodriguez-Prada C, Domenech-Abella J, Olaya B, Haro JM, Ayuso Mateos JL. Treatment coverage for depression in the general Spanish population and the impact of the Covid-19 pandemic. Heliyon. 2024 Jun 8;10(11):e32594. doi: 10.1016/j.heliyon.2024.e32594. eCollection 2024 Jun 15.
PubMed 38961986Zhang Z, Domenech-Abella J, Rodeiro-Boliart J, Gete-Alejandro I, Ayuso-Mateos JL, Miret M, Perez EL, Godino-Cruz J, Haro JM, Olaya B. The impact of physical multimorbidity on common mental disorders and the role of loneliness and social support: A three-year follow-up study. J Affect Disord. 2026 Aug 15;407:121795. doi: 10.1016/j.jad.2026.121795. Epub 2026 Apr 13.
PubMed 41985760Rodriguez-Prada C, Cabello M, Caballero FF, Dolz-Del-Castellar B, Francia L, Miret M, Haro JM, Domenech-Abella J, Olaya B, Ayuso-Mateos JL. Analyzing the Impact of Depression on All-Cause Mortality in Different Sex and Age Groups: A 11-Year Follow-Up Study of Spanish Population. Int J Soc Psychiatry. 2026 Mar 22:207640261430311. doi: 10.1177/00207640261430311. Online ahead of print.
PubMed 41865302Longo V, Domenech-Abella J, Gete-Alejandro I, Ayuso-Mateos JL, Miret M, Godino-Cruz J, Lara E, Cristobal-Narvaez P, Haro JM. The association between loneliness and suicide ideation: A cross-sectional comparison of Latin American immigrants and Spanish natives in Spain. J Affect Disord. 2026 Aug 1;406:121347. doi: 10.1016/j.jad.2026.121347. Epub 2026 Feb 5.
PubMed 41653995
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ageing and Health. Spanish Longitudinal Study on Ageing, Physical and Mental Health, and Its Determinants
- ClinicalTrials.gov ID
- NCT03343886
- Acronym / sponsor ID
- COURAGE2020
- Conditions
- Health, Subjective, Disability, Evaluation, Chronic Disease, Mental Disorder, Aging, Loneliness
- Keywords
- Health Status, Well-being, Mental Health, Risk Factors, Aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,755 participants (actual)
- Lead sponsor
- Fundación de Investigación Biomédica - Hospital Universitario de La PrincesaUniversity, hospital or other
- Collaborators
- Fundació Sant Joan de Déu, Universidad Autonoma de Madrid, Centro de Investigación Biomédica en Red de Salud Mental
- Study start
- Jul 2011 (actual)
- Primary completion
- May 2012 (actual)
- Study completion
- Oct 2025 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Posted 15 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ageing with Health is a longitudinal cohort study aimed to examine trajectories of health, disability and wellbeing and their determinants for Spanish ageing population. The data that makes up the baseline was collected from a nationally representative sample of non-institutionalized adults as part of the "Collaborative Research on Aging in Europe (COURAGE in Europe)" project between July 2011 and May 2012. The second wave was carried out as part of the "Age with Health" project between December 2014 and June 2015, and three years later, in 2018, the third wave was carried out. In 2019-2021, a new cohort of participants were brought in (2019 cohort), some of whom were interviewed again by telephone during the first Coronavirus (COVID-19) lockdown, in early 2020. In 2022, the fourth wave of the 2011 cohort was evaluated, and in 2023, the second wave of the 2019 cohort was evaluated. Finally, in 2025, the fifth wave of the 2011 cohort and the third wave of the 2019 cohort were evaluated, which are the last follow-ups in this study.
Detailed description
Study Design:
A prospective cohort general population study.
Sample:
Wave 1: A nationally representative sample of non-institutionalized adults aged 18 years or older from the Spanish population was collected (with an over-sampling of people aged 50+ years). A multi-stage clustered design was employed; four strata based on the number of inhabitants of the municipalities were built for each of the 17 Spanish autonomous communities. Clusters were selected within the strata with a probability of inclusion relative to their size. Within each cluster, households were randomly selected from a list of all households. In case there was more than one individual from the corresponding age group in the household, a random method was employed to select the individual participant.
Wave 2: Wave 1 sample was re-interviewed (Wave 2) in 2014-2015.
Wave 3: in 2018, participants were again evaluated. Complementarily, between 2019 and 2021 a new sample from the regions of Madrid and Barcelona were brought in, and it was interviewed again by telephone during the first COVID-19 lockdown, in May-June 2020.
Wave 4: a new evaluation of the participants of both cohorts 2011 and 2019 was carried out, in the fist case it terminated in 2022, while the data collection for 2019 cohort terminated in 2023.
Wave 5: the last follow-up of both cohorts was carried out in 2025.
Data collection:
Face-to-face interviews by Computer-Assisted Personal Interviewing at the respondents' homes by trained interviewers. All interviewers received a standardized training. Data quality control was also performed. A proxy interview was administered in those cases in which the participant presents physical or cognitive limitations that may impede the correct administration of the individual interview.
Main project objectives:
To assess trajectories of general health, disability and well-being in Spanish ageing population.
Secondary objectives:
To identify trajectories of healthy ageing (in terms of physical health, mental health, functioning and well-being) in Spanish adult population as well as their determinants To analyse prevalence and impact of chronic health conditions, mental health problems, well-being and loneliness on mortality in Spanish adult population.
To determine risk factors for incidence and persistence of mental and physical health problems in Spanish ageing population.
Main project hypotheses:
The trajectories of health, functioning and well-being will be encompassed by relevant environmental factors such as social support, loneliness and health care utilization, personal factors (socio-demographic characteristics, healthy lifestyles, and high cognitive reserve among others) and other biological and health-related factors (weight, height, waist circumference, executive functions, blood pressure, grip strength, vision acuity, presence of mental and physical health problems and quality of life).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 2011 | – | –A nationally representative sample of 4753 non-institutionalized adults aged 18 years or older from the Spanish population was collected (with an over-sampling of people aged 50+ years). A multi-stage clustered design was employed. A total of 2528 individuals were re-interviewed in 2014. In 2018, 1577 were again evaluated. In 2022, 963 participants took part of another study's evaluation. The last follow-up of this cohort was conducted in 2025, when 595 participants were evaluated. |
| Cohort 2019 | – | –3002 participants from the regions of Madrid and Barcelona were brought in between 2019 and 2021. The second wave of this cohort was conducted in 2023, and 1,116 participants were evaluated. This cohort was last evaluated in 2025, with 844 participants. In 2020, during the first Coronavirus (COVID-19) lockdown, 1166 of the participants from the first wave of the cohort were telephonically interviewed, a lateral sub-study evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community-living individuals in Spain aged 18 years or older
Key inclusion criteria (2 listed)
- Non-institutionalized Spanish residents
- 18 years and over
Key exclusion criteria (1 listed)
- Institutionalized population
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Heath Status
Time frame: Baseline
Measure: Health composite total score. Construct: Health status. Final result: A global total score. Range: 0-100. 0 means lower health status.
Disability
Time frame: Baseline
Measure: World Health Organization's Disability Assessment Schedule-II (WHODAS-II). Construct: Disability. Final result: A global total score. Range: 0-100. 0 means lower disability
Experienced Well-being
Time frame: Baseline
Abbreviated Version of the Day Reconstruction Method. Construct: Experienced wellbeing. Final Result: The used scale reports two global scores: * Positive Affect total score. Range: 0-100 where 0 means lower positive affect. * Negative Affect total score. Range 0-100 where 0 means lower negative affect.
Quality of Life (WHOQOL-AGE)
Time frame: Baseline
Measure: World Health Organization Quality of Life-Age (WHOQOL-AGE) (Caballero, et al., 2013). Construct: Quality of life. Final Result: A global total score. Range 0-100. 0 means lower quality of life
6 secondary outcomes
Number of Participants With Depression
Time frame: Baseline
Presence of Suicide Behavior
Time frame: Baseline
Presence of Anxiety Disorders
Time frame: Baseline
Presence of Diabetes
Time frame: Baseline
Presence of Lung Disease
Time frame: Baseline
Presence of Stroke
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36806591Gabarrell-Pascuet A, Varga TV, Moneta MV, Ayuso-Mateos JL, Lara E, Olaya B, Haro JM, Domenech-Abella J. What factors explain the changes in major depressive disorder symptoms by age group during the COVID-19 pandemic? A longitudinal study. J Affect Disord. 2023 May 1;328:72-80. doi: 10.1016/j.jad.2023.02.042. Epub 2023 Feb 16.
- Results publication: PubMed 32331406Bayes-Marin I, Fernandez D, Lara E, Martin-Maria N, Miret M, Moreno-Agostino D, Ayuso-Mateos JL, Sanchez-Niubo A, Haro JM, Olaya B. Trajectories of Immediate and Delayed Verbal Memory in the Spanish General Population of Middle-aged and Older Adults. Brain Sci. 2020 Apr 22;10(4):249. doi: 10.3390/brainsci10040249.
- Results publication: PubMed 31382535Olaya B, Moneta MV, Lara E, Miret M, Martin-Maria N, Moreno-Agostino D, Ayuso-Mateos JL, Abduljabbar AS, Haro JM. Fruit and Vegetable Consumption and Potential Moderators Associated with All-Cause Mortality in a Representative Sample of Spanish Older Adults. Nutrients. 2019 Aug 2;11(8):1794. doi: 10.3390/nu11081794.
- Results publicationMoreno-Agostino, D., de la Torre-Luque, A., de la Fuente, J., Lara, E., Martín-María, N., Moneta, M. V., … & Ayuso-Mateos, J. L. (2020). Determinants of Subjective Wellbeing Trajectories in Older Adults: A Growth Mixture Modeling Approach. Journal of Happiness Studies, 1-18.
- Results publication: PubMed 31237442Martin-Maria N, Caballero FF, Miret M, Tyrovolas S, Haro JM, Ayuso-Mateos JL, Chatterji S. Differential impact of transient and chronic loneliness on health status. A longitudinal study. Psychol Health. 2020 Feb;35(2):177-195. doi: 10.1080/08870446.2019.1632312. Epub 2019 Jun 25.
- Results publication: PubMed 32554229Lara E, Moreno-Agostino D, Martin-Maria N, Miret M, Rico-Uribe LA, Olaya B, Cabello M, Haro JM, Ayuso-Mateos JL. Exploring the effect of loneliness on all-cause mortality: Are there differences between older adults and younger and middle-aged adults? Soc Sci Med. 2020 Aug;258:113087. doi: 10.1016/j.socscimed.2020.113087. Epub 2020 May 30.
- Results publication: PubMed 32866758Gayete S, Gine A, Miret M, Ayuso-Mateos JL, Haro JM, Olaya B. Cognitive function associated with different diagnoses of anxiety disorders over the lifespan: Results from a Spanish representative sample. J Anxiety Disord. 2020 Oct;75:102296. doi: 10.1016/j.janxdis.2020.102296. Epub 2020 Aug 20.
- Results publication: PubMed 32791563Martin-Maria N, Caballero FF, Lara E, Domenech-Abella J, Haro JM, Olaya B, Ayuso-Mateos JL, Miret M. Effects of transient and chronic loneliness on major depression in older adults: A longitudinal study. Int J Geriatr Psychiatry. 2021 Jan;36(1):76-85. doi: 10.1002/gps.5397. Epub 2020 Sep 10.
- Results publication: PubMed 34281004Garcia-Esquinas E, Ortola R, Gine-Vazquez I, Carnicero JA, Manas A, Lara E, Alvarez-Bustos A, Vicente-Rodriguez G, Sotos-Prieto M, Olaya B, Garcia-Garcia FJ, Gusi N, Banegas JR, Rodriguez-Gomez I, Struijk EA, Martinez-Gomez D, Lana A, Haro JM, Ayuso-Mateos JL, Rodriguez-Manas L, Ara I, Miret M, Rodriguez-Artalejo F. Changes in Health Behaviors, Mental and Physical Health among Older Adults under Severe Lockdown Restrictions during the COVID-19 Pandemic in Spain. Int J Environ Res Public Health. 2021 Jul 1;18(13):7067. doi: 10.3390/ijerph18137067.
- Results publication: PubMed 35029840Gabarrell-Pascuet A, Moneta MV, Ayuso-Mateos JL, Miret M, Lara E, Haro JM, Olaya B, Domenech-Abella J. The effect of loneliness and social support on the course of major depressive disorder among adults aged 50 years and older: A longitudinal study. Depress Anxiety. 2022 Feb;39(2):147-155. doi: 10.1002/da.23236. Epub 2022 Jan 14.
- Results publicationRodeiro, J., Olaya, B., Haro, J. M., Gabarrell-Pascuet, A., Ayuso-Mateos, J. L., Francia, L., … & Domènech-Abella, J. (2025). The longitudinal relationship among physical activity, loneliness, and mental health in middle-aged and older adults: Results from the Edad con Salud cohort. Mental Health and Physical Activity, 100667.
- Results publication: PubMed 38961986Francia L, De Giorgi R, Lara E, Del Castellar BD, Castelletti C, Rodriguez-Prada C, Domenech-Abella J, Olaya B, Haro JM, Ayuso Mateos JL. Treatment coverage for depression in the general Spanish population and the impact of the Covid-19 pandemic. Heliyon. 2024 Jun 8;10(11):e32594. doi: 10.1016/j.heliyon.2024.e32594. eCollection 2024 Jun 15.
- Age with health website infoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. A sharing plan description has to be still agreed between the different Principal Investigators
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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.
Jose Luis Ayuso Mateos, MD, PhD principal investigator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Josep Maria Haro, MD, PhD principal investigator
Fundació Sant Joan de Déu
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health, Subjective and Disability, Evaluation, run by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa at 3 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?
The sponsor lists 2 inclusion and 1 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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Heath Status (time frame: Baseline). 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 NCT03343886, which also lists 63 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 29 Oct 2026.