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Trial record 1 of 1 for:    NCT03343886
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Trajectories of Health in Spanish Population

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ClinicalTrials.gov Identifier: NCT03343886
Recruitment Status : Unknown
Verified November 2017 by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa.
Recruitment status was:  Recruiting
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Collaborator:
Fundació Sant Joan de Déu
Information provided by (Responsible Party):
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

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. 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.

Condition or disease
Health, Subjective Disability, Evaluation Mental Health Wellness 1 Chronic Disease Mental Disorder Aging

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).

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Trajectories of Health, Disability and Well-being in Spanish Ageing Population
Actual Study Start Date : July 2011
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019



Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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


Secondary Outcome Measures :
  1. 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).

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)


  10. Change from Wave 1 Blood pressure [ Time Frame: Three times (each 3.5 years) ]
    Construct: Blood pressure Measure: Blood pressure monitor

  11. 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)

  12. 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)

  13. 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)


  14. 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)

  15. 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)

  16. 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)


  17. 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)


  18. 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)


Other Outcome Measures:
  1. 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.

  2. 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

  3. 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


  4. 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

  5. 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

  6. 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

  7. Change from Wave 1 Weight [ Time Frame: Three times (each 3.5 years) ]
    Construct: Weight Result: kilograms

  8. Change from Wave 1 Height [ Time Frame: Three times (each 3.5 years) ]
    Construct: Height Measure: Centimeters

  9. Change from Wave 1 Waist circumference [ Time Frame: Three times (each 3.5 years) ]
    Construct: Waist circumference. Measure: Centimeters

  10. Change from Wave 1 Handgrip [ Time Frame: Three times (each 3.5 years) ]
    Construct: Handgrip. Measure: Smedley Hand Dynamometer (Stoelting Company). Result: Kilogram

  11. 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.

  12. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Community-living individuals in Spain aged 18 years or older
Criteria

Inclusion Criteria:

  • Non-institutionalized Spanish residents
  • 18 years and over

Exclusion Criteria:

  • Institutionalized population

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03343886


Contacts
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Contact: Maria Cabello, PhD +34 914972447 maria.cabello@uam.es
Contact: Marta Miret, PhD +34 91497 2716 marta.miret@uam.es

Locations
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Spain
Fundació Sant Joan de Déu Recruiting
Sant Boi De Llobregat, Barcelona, Spain, 08830
Contact: Josep Maria Haro, MD, PhD    (+34) 93 640 6350 ext 12544    jmharo@pssjd.org   
Contact: Beatriz Olaya, PhD    +34 93 556 96 77    beatriz.olaya@pssjd.org   
Principal Investigator: Josep Maria Haro, MD, PhD         
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa Recruiting
Madrid, Spain, 28006
Contact: Maria Cabello, PhD    +914972447    maria.cabello@uam.es   
Principal Investigator: Jose Luis Ayuso Mateos, Md, PhD         
Sponsors and Collaborators
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Fundació Sant Joan de Déu
Investigators
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Principal Investigator: Jose Luis Ayuso Mateos, MD, PhD Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Additional Information:
Publications of Results:

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Responsible Party: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
ClinicalTrials.gov Identifier: NCT03343886    
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 )
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: A sharing plan description has to be still agreed between the different Principal Investigators

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa:
Health Status
Well-being
Mental Health
Risk Factors
Aging
Additional relevant MeSH terms:
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Chronic Disease
Mental Disorders
Disease Attributes
Pathologic Processes