Skip to content

Ageing and Health. Spanish Longitudinal Study

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03343886
Enrollment
7755
Registered
2017-11-17
Start date
2011-07-31
Completion date
2026-12-31
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Chronic Disease, Cognitive Decline, Disability, Evaluation, Health, Subjective, Loneliness, Mental Disorder, Well-being

Keywords

Health Status, Well-being, Mental Health, Risk Factors, Aging

Brief summary

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.

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).

Interventions

None listed

Sponsors

Fundació Sant Joan de Déu
CollaboratorOTHER
Universidad Autonoma de Madrid
CollaboratorOTHER
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Non-institutionalized Spanish residents * 18 years and over

Exclusion criteria

* Institutionalized population

Design outcomes

Primary

MeasureTime frameDescription
Heath StatusBaselineMeasure: Health composite total score. Construct: Health status. Final result: A global total score. Range: 0-100. 0 means lower health status.
Quality of Life (WHOQOL-AGE)BaselineMeasure: 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
Experienced Well-beingBaselineAbbreviated 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.
DisabilityBaselineMeasure: 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

Secondary

MeasureTime frameDescription
Presence of Anxiety DisordersBaselineMeasure: 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)
Number of Participants With DepressionBaselineMeasure: 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).
Presence of Suicide BehaviorBaselineMeasure: 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)
Presence of DiabetesBaselineConstruct: Presence of diabetes Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for diabetes Values: (Yes/No)
Presence of Lung DiseaseBaselineConstruct: 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)
Presence of StrokeBaselineConstruct: Presence of stroke Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for stroke Values: (Yes/No)

Other

MeasureTime frameDescription
Tobacco Use InformationBaselineConstruct: 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)
Intensity of Subjective Perception of LonelinessBaselineConstruct: 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
Alcohol Use InformationBaselineConstruct: 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.
Level of Social SupportBaselineConstruct: 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.
Level of Physical ActivityBaselineConstruct: 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

Countries

Spain

Participant flow

Recruitment details

Spanish general adult population non-institutionalized; aged 18+ years with oversampling of those aged 50+ years and those 80+ years); multi-stage stratified sampling; representative sample.

Pre-assignment details

Respondents unable to undertake the interview because of severe cognitive or physical impairment were administered a shorter version of the questionnaire to a proxy respondent.

Participants by arm

ArmCount
Cohort 2011 Sample Demographic Characteristics
The 2011 Cohort is part of a nationally representative sample of the Spanish noninstitutionalized adult population. Potential respondents were selected by a stratified, multistage, clustered area probability design, without replacement, according to the Spanish regions and population size.
4
Cohort 2019 Sample Demographic Characteristics
In 2019-2021 3,002 participants were brought in (2019 cohort), using the same sample characteristics .
3,002
Total3,006

Baseline characteristics

CharacteristicCohort 2011 Sample Demographic CharacteristicsCohort 2019 Sample Demographic CharacteristicsTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
2011 Participants1,135 Participants3146 Participants
Age, Categorical
Between 18 and 65 years
2742 Participants1,867 Participants4609 Participants
Age, Continuous60.44 years
STANDARD_DEVIATION 16.24
58.19 years
STANDARD_DEVIATION 17.89
59.32 years
STANDARD_DEVIATION 17.07
Education
High School
874 Participants724 Participants1598 Participants
Education
Less than primary
1,001 Participants353 Participants1354 Participants
Education
missing data
1 Participants1 Participants2 Participants
Education
No education
373 Participants100 Participants473 Participants
Education
Post graduate degree
64 Participants175 Participants239 Participants
Education
Primary
1,306 Participants761 Participants2067 Participants
Education
Secondary
562 Participants428 Participants990 Participants
Education
University+
572 Participants460 Participants1032 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
4753 Participants3002 Participants7755 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Health Status66.55 units on a scale
STANDARD_DEVIATION 13.11
68.95 units on a scale
STANDARD_DEVIATION 19.87
67.75 units on a scale
STANDARD_DEVIATION 16.49
Marital status
Cohabiting
175 Participants127 Participants302 Participants
Marital status
Married
2,670 Participants1,666 Participants4336 Participants
Marital status
Separated/divorced
346 Participants306 Participants652 Participants
Marital status
Single
680 Participants495 Participants1175 Participants
Marital status
widowed
882 Participants408 Participants1290 Participants
Region of Enrollment
Spain
4753 Participants3002 Participants7755 Participants
Sex: Female, Male
Female
2,602 Participants1,302 Participants3904 Participants
Sex: Female, Male
Male
2,151 Participants1,700 Participants3851 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
591 / 4,753157 / 3,002
other
Total, other adverse events
1,447 / 4,7531,474 / 3,002
serious
Total, serious adverse events
706 / 4,753234 / 3,002

Outcome results

Primary

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

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Cohort 2011Disability11.17 score on a scaleStandard Deviation 17.59
Cohort 2019Disability9.01 score on a scaleStandard Deviation 18.2
Primary

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.

Time frame: Baseline

Population: Proxy respondent were not analysed

ArmMeasureGroupValue (MEAN)Dispersion
Cohort 2011Experienced Well-beingPositive Affect4.88 score on a scaleStandard Deviation 1.11
Cohort 2011Experienced Well-beingNegative Affect0.64 score on a scaleStandard Deviation 0.89
Cohort 2019Experienced Well-beingPositive Affect4.75 score on a scaleStandard Deviation 1.59
Cohort 2019Experienced Well-beingNegative Affect0.33 score on a scaleStandard Deviation 0.61
Primary

Heath Status

Measure: Health composite total score. Construct: Health status. Final result: A global total score. Range: 0-100. 0 means lower health status.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Cohort 2011Heath Status66.55 score on a scaleStandard Deviation 13.11
Cohort 2019Heath Status68.95 score on a scaleStandard Deviation 19.87
Primary

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

Time frame: Baseline

Population: Proxy respondent were not analysed

ArmMeasureValue (MEAN)Dispersion
Cohort 2011Quality of Life (WHOQOL-AGE)72.30 score on a scaleStandard Deviation 14.9
Cohort 2019Quality of Life (WHOQOL-AGE)76.17 score on a scaleStandard Deviation 15.25
Secondary

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).

Time frame: Baseline

Population: Proxy respondent were not analysed

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Cohort 2011Number of Participants With Depression510 Participants
Cohort 2019Number of Participants With Depression203 Participants
Secondary

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)

Time frame: Baseline

Population: Proxy respondent were not analysed

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Cohort 2011Presence of Anxiety Disorders69 Participants
Cohort 2019Presence of Anxiety Disorders77 Participants
Secondary

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)

Time frame: Baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Cohort 2011Presence of Diabetes661 Participants
Cohort 2019Presence of Diabetes353 Participants
Secondary

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)

Time frame: Baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Cohort 2011Presence of Lung Disease399 Participants
Cohort 2019Presence of Lung Disease152 Participants
Secondary

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)

Time frame: Baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Cohort 2011Presence of Stroke183 Participants
Cohort 2019Presence of Stroke82 Participants
Secondary

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)

Time frame: Baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Cohort 2011Presence of Suicide Behavior161 Participants
Cohort 2019Presence of Suicide Behavior75 Participants
Other Pre-specified

Alcohol Use Information

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.

Time frame: Baseline

Population: Proxy respondent were not analysed

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Cohort 2011Alcohol Use InformationLifetime abstainers1,345 Participants
Cohort 2011Alcohol Use InformationOccasional drinkers1,424 Participants
Cohort 2011Alcohol Use InformationNon-heavy drinker1,671 Participants
Cohort 2011Alcohol Use InformationInfrequent heavy drinker111 Participants
Cohort 2011Alcohol Use InformationFrequent heavy drinker32 Participants
Cohort 2011Alcohol Use InformationMissing0 Participants
Cohort 2019Alcohol Use InformationFrequent heavy drinker38 Participants
Cohort 2019Alcohol Use InformationLifetime abstainers871 Participants
Cohort 2019Alcohol Use InformationInfrequent heavy drinker95 Participants
Cohort 2019Alcohol Use InformationOccasional drinkers1,055 Participants
Cohort 2019Alcohol Use InformationMissing6 Participants
Cohort 2019Alcohol Use InformationNon-heavy drinker846 Participants
Other Pre-specified

Intensity of Subjective Perception of Loneliness

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

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Cohort 2011Intensity of Subjective Perception of Loneliness12.34 score on a scaleStandard Deviation 24.25
Cohort 2019Intensity of Subjective Perception of Loneliness10.74 score on a scaleStandard Deviation 22.82
Other Pre-specified

Level of Physical Activity

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

Time frame: Baseline

Population: Proxy respondent were not analysed

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Cohort 2011Level of Physical Activityhigh1,464 Participants
Cohort 2011Level of Physical ActivityModerate1,724 Participants
Cohort 2011Level of Physical ActivityLow1,395 Participants
Cohort 2019Level of Physical Activityhigh898 Participants
Cohort 2019Level of Physical ActivityModerate1,013 Participants
Cohort 2019Level of Physical ActivityLow991 Participants
Other Pre-specified

Level of Social Support

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.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Cohort 2011Level of Social Support77.50 score on a scaleStandard Deviation 16.73
Cohort 2019Level of Social Support77.44 score on a scaleStandard Deviation 17.7
Other Pre-specified

Tobacco Use Information

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)

Time frame: Baseline

Population: Proxy respondent were not analysed

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Cohort 2011Tobacco Use InformationNever smokers2,339 Participants
Cohort 2011Tobacco Use InformationDaily smokers1,049 Participants
Cohort 2011Tobacco Use InformationNon daily smokers100 Participants
Cohort 2011Tobacco Use InformationFormer smokers1095 Participants
Cohort 2019Tobacco Use InformationFormer smokers690 Participants
Cohort 2019Tobacco Use InformationNever smokers1,543 Participants
Cohort 2019Tobacco Use InformationNon daily smokers52 Participants
Cohort 2019Tobacco Use InformationDaily smokers626 Participants

Source: ClinicalTrials.gov · Data processed: Jul 12, 2026