Ageing and Health. Spanish Longitudinal Study

October 10, 2024 updated by: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Ageing and Health. Spanish Longitudinal Study on Ageing, Physical and Mental Health, and Its Determinants

Age 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. During 2022 a new evaluation of the participants of both cohorts (2011 and 2019) is expected.

Study Overview

Status

Active, not recruiting

Conditions

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 is still going on, expected to terminate for December 2023.

Wave 5: a new and last evaluation is expected for both cohort 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 Type

Observational

Enrollment (Actual)

7755

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28029
        • Universidad Autonoma de Madrid
      • Madrid, Spain, 28006
        • Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
    • Barcelona
      • Sant Boi De Llobregat, Barcelona, Spain, 08830
        • Fundació Sant Joan de Déu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Community-living individuals in Spain aged 18 years or older

Description

Inclusion Criteria:

  • Non-institutionalized Spanish residents
  • 18 years and over

Exclusion Criteria:

  • Institutionalized population

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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. Finally, in 2022, 963 participants took part of another study's evaluation.
Cohort 2019
3002 participants from the regions of Madrid and Barcelona were brought in between 2019 and 2021. They are now under a second evaluation (2023). In 2020, during the first Coronavirus (COVID-19) lockdown, 1166 of the participants from the first wave of the cohort was telephonically interviewed, a lateral sub-study evaluation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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
Baseline
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.
Baseline
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
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Depression
Time Frame: Baseline

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).
Baseline
Presence of Suicide Behavior
Time Frame: Baseline

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)
Baseline
Presence of Anxiety Disorders
Time Frame: Baseline

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)
Baseline
Presence of Diabetes
Time Frame: Baseline
Construct: Presence of diabetes Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for diabetes Values: (Yes/No)
Baseline
Presence of Lung Disease
Time Frame: Baseline
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)
Baseline
Presence of Stroke
Time Frame: Baseline
Construct: Presence of stroke Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for stroke Values: (Yes/No)
Baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol Use Information
Time Frame: Baseline

Construct: Alcohol use Measure: Self-reported information of how many standard drinks per day in last 7 days have been used.

Values: four categories of alcohol use:

0= Lifetime abstainers: Participants that have never used alcohol

  1. Occasional drinkers: Participants that have ever used alcohol but not in the previous 7 days
  2. Non-heavy drinker: Participants did consume alcohol in the last 30 days and in the last 7 days
  3. Infrequent heavy drinker: Participants did consume alcohol 1-2 days per week, with 5 or more standard drinks per day in last 7 days for men and 4 or more standard drinks per day in last 7 days for women.
  4. Frequent heavy drinkers: Participants did consume alcohol 3 or more days per week with 5 or more standard drinks per day in last 7 days for men and 4 or more standard drinks per day in last 7 days for women.
Baseline
Tobacco Use Information
Time Frame: Baseline

Construct: Tobacco use Measure: Self-reported information of how many cigarettes/pipes/tobacco products/ have been used in the last week.

Values: Four categories of tobacco use:

0= Never smokers: Participants who have never used tobacco

  1. Daily smokers: Participants who have used tobacco last week
  2. Non daily smokers: Participants who have ever used tobacco but not in the previous week
  3. Former smokers: Participants who smoked in the past (ex smokers)
Baseline
Level of Physical Activity
Time Frame: Baseline

Construct: Level of physical activity Scale: Global Physical Activity Questionnaire version 2 (GPAQ v2); It collects information on physical activity participation in three settings (or domains) and sedentary behavior. The responses given by the participants have been converted to Metabolic Equivalent to Task (MET) values. Applying MET values to activity levels allows for calculating total physical activities.

Values: Three values of physical activity can be obtained 3=High physical activity 2=Moderate physical activity

1=Low physical activity
Baseline
Level of Social Support
Time Frame: Baseline
Construct: Social Support Measure: 3-Item Oslo Social Support Scale (OSLO) (Abiola et al., 2013) Result: A global total score, then transformed into a percentile scale. Range: 0-100. Higher scores indicate a higher social support.
Baseline
Intensity of Subjective Perception of Loneliness
Time Frame: Baseline
Construct: Loneliness Measure: Three-item University of California, Los Angeles (UCLA) Loneliness Scale (Hughes et al, 2004) Result: A total loneliness score, then transformed into a percentile scale. Range: 0-100. Higher scores means higher loneliness
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Collaborators

Fundació Sant Joan de Déu
Universidad Autonoma de Madrid

Investigators

  • Principal Investigator: Jose Luis Ayuso Mateos, MD, PhD, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 8, 2017

First Submitted That Met QC Criteria

November 10, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 10, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COURAGE2020
  • FP7/2007-2013- 316795 (Other Grant/Funding Number: European Commission)
  • ACI2009-1010 (Other Grant/Funding Number: Spanish Ministry of Science and Innovation)
  • PS09/00295 (Other Grant/Funding Number: Carlos III Health Institute)
  • PS09/01845 (Other Grant/Funding Number: Carlos III Health Institute)
  • PI12/01490 (Other Grant/Funding Number: Carlos III Health Institute)
  • PI13/00059 (Other Grant/Funding Number: Carlos III Health Institute)
  • PI16/01073 (Other Grant/Funding Number: Carlos III Health Institute)
  • PI16/00812 (Other Grant/Funding Number: Carlos III Health Institute)
  • PI19/00088 (Other Grant/Funding Number: Carlos III Health Institute)
  • PI19/00103 (Other Grant/Funding Number: Carlos III Health Institute)
  • PI19/00150 (Other Grant/Funding Number: Carlos III Health Institute)
  • PI19/00235 (Other Grant/Funding Number: Carlos III Health Institute)
  • PI22/00309 (Other Grant/Funding Number: Carlos III Health Institute)
  • PI22/00340 (Other Grant/Funding Number: Carlos III Health Institute)
  • PI22/00374 (Other Grant/Funding Number: Carlos III Health Institute)
  • PI22/00375 (Other Grant/Funding Number: Carlos III Health Institute)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

A sharing plan description has to be still agreed between the different Principal Investigators

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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