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NCT Number: NCT03343886

Ageing and Health. Spanish Longitudinal Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Health, Subjective Aging Behavior Chronic Disease Cognition Disorders Cognitive Decline Cognitive Dysfunction Disability, Evaluation Disease Attributes Loneliness Mental Disorder Mental Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fundació Sant Joan de Déu, Sant Boi de Llobregat, Barcelona, Spain

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non-institutionalized Spanish residents
  • 18 years and over

Exclusion criteria

  • Institutionalized population

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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

Secondary outcomes

  1. 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).

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

Other outcomes

  1. 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

    • Occasional drinkers: Participants that have ever used alcohol but not in the previous 7 days
    • Non-heavy drinker: Participants did consume alcohol in the last 30 days and in the last 7 days
    • 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.
    • 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.

  2. 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

    • Daily smokers: Participants who have used tobacco last week
    • Non daily smokers: Participants who have ever used tobacco but not in the previous week
    • Former smokers: Participants who smoked in the past (ex smokers)

  3. 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

  4. 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.

  5. 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

Sponsors and collaborators

Lead sponsor

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Other

Collaborators

  • Fundació Sant Joan de Déu
  • Universidad Autonoma de Madrid

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2026
First posted
Nov 17, 2017
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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