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Clinical Trials/NCT03343886
NCT03343886
Active, not recruiting
Not Applicable

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

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa3 sites in 1 country7,755 target enrollmentJuly 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Health, Subjective
Sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Enrollment
7755
Locations
3
Primary Endpoint
Heath Status
Status
Active, not recruiting
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
December 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Non-institutionalized Spanish residents
  • 18 years and over

Exclusion Criteria

  • Institutionalized population

Outcomes

Primary Outcomes

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.

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

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.

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

  • Presence of Lung Disease(Baseline)
  • Number of Participants With Depression(Baseline)
  • Presence of Suicide Behavior(Baseline)
  • Presence of Anxiety Disorders(Baseline)
  • Presence of Diabetes(Baseline)
  • Presence of Stroke(Baseline)

Study Sites (3)

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