Trajectories of Health in Spanish Population

November 10, 2017 updated by: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Longitudinal Trajectories of Health, Disability and Well-being in Spanish Ageing Population

Age with Health is a longitudinal cohort study aimed to examine trajectories of health, disability and wellbeing and their determinants for Spanish ageing population. Two waves have carried out so far. Wave 1 (2011-2012) and Wave 2 (2014-2015). Wave 3 will be conducted 2018, including also a new cohort of participants (Called 2018 Cohort). The study will provide reliable measures of population ageing and adult health in Spain - and will provide the basis for cross-country comparisons with longitudinal studies conducted in other countries.

Study Overview

Status

Unknown

Conditions

Detailed Description

Study Design:

A prospective cohort general population study. Three study Waves

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. A total of 4,753 respondents were interviewed and signed the written consent.

Wave 2: Wave 1 sample was re-interviewed (Wave 2) in 2014-2015. The mean follow-up period was 3.5 years (SD = 0.18). A total of 2,528 individuals were re-interviewed. The response rate in the second wave was 69.5%. This cohort will be re-interviewed after 3.5 years (Wave 3).

Wave 3: Following the same sampling methods than in Wave 1 approximately 3000 participants from Madrid and Barcelona will be interviewed for the first time.

Data collection:

Face-to-face interviews by Computer-Assisted Personal Interviewing at the respondents' homes by trained interviewers. All interviewers receive a standardized training. Data quality control is also performed.

Main objective:

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 psychical 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.

Hypothesis:

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 (Anticipated)

5000

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Madrid, Spain, 28006
        • Recruiting
        • Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
        • Contact:
        • Principal Investigator:
          • Jose Luis Ayuso Mateos, Md, PhD
    • Barcelona
      • Sant Boi De Llobregat, Barcelona, Spain, 08830
        • Recruiting
        • Fundació Sant Joan de Deu
        • Contact:
          • Josep Maria Haro, MD, PhD
          • Phone Number: 12544 (+34) 93 640 6350
          • Email: jmharo@pssjd.org
        • Contact:
        • Principal Investigator:
          • Josep Maria Haro, MD, PhD

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

Genders Eligible for Study

All

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Wave 1 Heath Status
Time Frame: Three times (each 3.5 years)
Measure: Health composite total score (Salomon, 2003). Construct: Health status. Final result: A global total score. Range: 0-100. 0 means lower health status.
Three times (each 3.5 years)
Change from Wave 1 Disability
Time Frame: Three times (each 3.5 years)
Measure: World Health Organization's Disability Assessment Schedule-II (WHODAS-II). (World Health Organization, 2010). Construct: Disability. Final result: A global total score. Range: 0-100. 0 means lower disability
Three times (each 3.5 years)
Change from Wave 1 Instrumental Activities of Daily living
Time Frame: Three times (each 3.5 years)
Measure: Instrumental Activities of Daily Living Scale (Lawton & Brody, 1969). Construct: Instrumental activities of daily living. Final result: A global total score. Range 0-8. 0 means higher problems to perform activities.
Three times (each 3.5 years)
Change from Wave 1 Activities of Daily Living
Time Frame: Three times (each 3.5 years)
Measure: The Barthel Index (Van der Putten, 1999). Construct: Activities of Daily Living. Result: A global total score. Range 0-100. 0 means higher problems to perform activities.
Three times (each 3.5 years)
Change from Wave 1 Experienced Well-being
Time Frame: Three times (each 3.5 years)

Abbreviated Version of the Day Reconstruction Method (Miret, et al., 2012). 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.
Three times (each 3.5 years)
Change from Wave 1 Quality of life
Time Frame: Three times (each 3.5 years)
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
Three times (each 3.5 years)
Change from Wave 1 Eudaimonic Well-being
Time Frame: Three times (each 3.5 years)
Measure: The Flourishing Scale (Diener, et al., 2009). Construct: Eudaimonic Wellbeing. Final result: The scale used shows a total score. Range 8-56. 8 means lower eudaimonic well-being
Three times (each 3.5 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Wave 1 Depression
Time Frame: Three times (each 3.5 years)

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).
Three times (each 3.5 years)
Change from Wave 1 Suicide behavior
Time Frame: Three times (each 3.5 years)

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)
Three times (each 3.5 years)
Change from Wave 1 Anxiety
Time Frame: Three times (each 3.5 years)

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)
Three times (each 3.5 years)
Change from Wave 1 presence of diabetes
Time Frame: Three times (each 3.5 years)
Construct: Presence of diabetes Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for diabetes Values: (Yes/No)
Three times (each 3.5 years)
Change from Wave 1 presence of osteoarthritis
Time Frame: Three times (each 3.5 years)
Construct: Presence of osteoarthritis Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for osteoarthritis Values: (Yes/No)
Three times (each 3.5 years)
Change from Wave 1 presence of any lung disease
Time Frame: Three times (each 3.5 years)
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)
Three times (each 3.5 years)
Change from Wave 1 presence of stroke
Time Frame: Three times (each 3.5 years)
Construct: Presence of stroke Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for stroke Values: (Yes/No)
Three times (each 3.5 years)
Change from Wave 1 presence of chest angina
Time Frame: Three times (each 3.5 years)
Construct: Presence of chest angina Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for chest angina Values: (Yes/No)
Three times (each 3.5 years)
Change from Wave 1 presence of arthritis
Time Frame: Three times (each 3.5 years)

Construct: Presence of arthritis Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for arthritis.

Values: (Yes/No)
Three times (each 3.5 years)
Change from Wave 1 Blood pressure
Time Frame: Three times (each 3.5 years)
Construct: Blood pressure Measure: Blood pressure monitor
Three times (each 3.5 years)
Change from Wave 1 presence of cataracts
Time Frame: Three times (each 3.5 years)
Construct: Presence of cataracts Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for cataracts Values: (Yes/No)
Three times (each 3.5 years)
Change from Wave 1 presence of asthma
Time Frame: Three times (each 3.5 years)
Construct: Presence of asthma Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for asthma Values: (Yes/No)
Three times (each 3.5 years)
Change from Wave 1 presence of kidney disease
Time Frame: Three times (each 3.5 years)

Construct: Presence of any kidney disease Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for kidney disease.

Values: (Yes/No)
Three times (each 3.5 years)
Change from Wave 1 presence of liver disease
Time Frame: Three times (each 3.5 years)
Construct: Presence of liver disease Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for liver disease Values: (Yes/No)
Three times (each 3.5 years)
Change from Wave 1 presence of cancer
Time Frame: Three times (each 3.5 years)
Construct: Presence of any kind of cancer Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for any kind of cancer Values: (Yes/No)
Three times (each 3.5 years)
Change from Wave 1 presence of anaemia
Time Frame: Three times (each 3.5 years)

Construct: Presence of anaemia Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for anaemia.

Values: (Yes/No)
Three times (each 3.5 years)
Change from Wave 1 presence of thyroid problems
Time Frame: Three times (each 3.5 years)

Construct: Presence of any thyroid problems Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for any thyroid problems.

Values: (Yes/No)
Three times (each 3.5 years)
Change from Wave 1 presence of glaucoma
Time Frame: Three times (each 3.5 years)
Construct: Presence of glaucoma Measure: Self-reported information of 12-month presence of diagnosis and/or of treatment for glaucoma. Values: (Yes/No)
Three times (each 3.5 years)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Wave 1 Alcohol use
Time Frame: Three times (each 3.5 years)

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. 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.
  3. 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.
Three times (each 3.5 years)
Change from Wave 1 Tobacco use
Time Frame: Three times (each 3.5 years)

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 that have never used tobacco

  1. Non daily smokers: Participants that have ever used tobacco but not in the previous week
  2. Daily smokers: Participants that have used tobacco last week
Three times (each 3.5 years)
Change from Wave 1 Physical activity
Time Frame: Three times (each 3.5 years)

Construct: Level of physical activity Scale: Global Physical Activity Questionnaire version 2 (GPAQ v2) Values: Three values of physical activity can be obtained 3=High physical activity 2=Moderate physical activity

1=Low physical activity
Three times (each 3.5 years)
Change from Social Support
Time Frame: Three times (each 3.5 years)
Construct: Social Support Measure: 3-Item Oslo Social Support Scale (Abiola, 2013) Result: A global total Score Range: 3-14. 3 means lower social support
Three times (each 3.5 years)
Change from wave 1 Loneliness
Time Frame: Three times (each 3.5 years)
Construct: Loneliness Measure: Three-item University of California, Los Angeles (UCLA) Loneliness Scale (Hughes et al, 2004) Result: A total loneliness score Range: 3-9. Higher scores means higher loneliness
Three times (each 3.5 years)
Change from Wave 1 Size of Social network
Time Frame: Three times (each 3.5 years)
Construct: Size of Social Network Measure: Berkman-Syme Social Network Index Result: A Total score Range: 0-99. Higher score indicate bigger network that lower score
Three times (each 3.5 years)
Change from Wave 1 Weight
Time Frame: Three times (each 3.5 years)
Construct: Weight Result: kilograms
Three times (each 3.5 years)
Change from Wave 1 Height
Time Frame: Three times (each 3.5 years)
Construct: Height Measure: Centimeters
Three times (each 3.5 years)
Change from Wave 1 Waist circumference
Time Frame: Three times (each 3.5 years)
Construct: Waist circumference. Measure: Centimeters
Three times (each 3.5 years)
Change from Wave 1 Handgrip
Time Frame: Three times (each 3.5 years)
Construct: Handgrip. Measure: Smedley Hand Dynamometer (Stoelting Company). Result: Kilogram
Three times (each 3.5 years)
Change from Wave 1 Gait speed
Time Frame: Three times (each 3.5 years)
Construct: Gait speed. Measure: Gaid speed test. Result: Metres per second.
Three times (each 3.5 years)
Change from Wave 1 Cognitive Reserve
Time Frame: Three times (each 3.5 years)
Construct: Reserve Cognitive. Measure: Cognitive Reserve Questionnaire (CRQ, Rami, et al 211) Result: A Total score. Range 0-25 Higher scores means higher cognitive reserve
Three times (each 3.5 years)

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

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 (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

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)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 10, 2017

Last Verified

November 1, 2017

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)

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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