Clinical trial NCT03343886: Ageing and Health. Spanish Longitudinal Study
Official title: Ageing and Health. Spanish Longitudinal Study on Ageing, Physical and Mental Health, and Its Determinants
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Health, Subjective
Disability, Evaluation
Chronic Disease
Mental Disorder
Aging
Loneliness
Well-being
Cognitive Decline
Keywords: Health Status
Well-being
Mental Health
Risk Factors
Aging
Lead sponsor: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Sponsor class: OTHER
Collaborators: name: Fundació Sant Joan de Déu
name: Universidad Autonoma de Madrid
First posted: 2017-11-17
Enrollment: 7755
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Community-living individuals in Spain aged 18 years or older

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).

Eligibility criteria: Inclusion Criteria:

* Non-institutionalized Spanish residents
* 18 years and over

Exclusion Criteria:

* Institutionalized population

Primary outcomes:
measure: Heath Status
timeFrame: Baseline
measure: Disability
timeFrame: Baseline
measure: Experienced Well-being
timeFrame: Baseline
measure: Quality of Life (WHOQOL-AGE)
timeFrame: Baseline
Secondary outcomes:
measure: Number of Participants With Depression
timeFrame: Baseline
measure: Presence of Suicide Behavior
timeFrame: Baseline
measure: Presence of Anxiety Disorders
timeFrame: Baseline
measure: Presence of Diabetes
timeFrame: Baseline
measure: Presence of Lung Disease
timeFrame: Baseline
measure: Presence of Stroke
timeFrame: Baseline
Other outcomes:
measure: Alcohol Use Information
timeFrame: Baseline
measure: Tobacco Use Information
timeFrame: Baseline
measure: Level of Physical Activity
timeFrame: Baseline
measure: Level of Social Support
timeFrame: Baseline
measure: Intensity of Subjective Perception of Loneliness
timeFrame: Baseline
Locations:
city: Sant Boi De Llobregat
country: Spain
facility: Fundació Sant Joan de Déu
state: Barcelona
city: Madrid
country: Spain
facility: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Universidad Autónoma de Madrid
Study officials:
affiliation: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
name: Jose Luis Ayuso Mateos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miret M, Caballero FF, Olaya B, Koskinen S, Naidoo N, Tobiasz-Adamczyk B, Leonardi M, Haro JM, Chatterji S, Ayuso-Mateos JL. Association of experienced and evaluative well-being with health in nine countries with different income levels: a cross-sectional study. Global Health. 2017 Aug 23;13(1):65. doi: 10.1186/s12992-017-0290-0.
citation: Olaya B, Moneta MV, Domenech-Abella J, Miret M, Bayes I, Ayuso-Mateos JL, Haro JM. Mobility Difficulties, Physical Activity, and All-cause Mortality Risk in a Nationally representative Sample of Older Adults. J Gerontol A Biol Sci Med Sci. 2018 Aug 10;73(9):1272-1279. doi: 10.1093/gerona/glx121.
citation: Lara E, Koyanagi A, Domenech-Abella J, Miret M, Ayuso-Mateos JL, Haro JM. The Impact of Depression on the Development of Mild Cognitive Impairment over 3 Years of Follow-Up: A Population-Based Study. Dement Geriatr Cogn Disord. 2017;43(3-4):155-169. doi: 10.1159/000455227. Epub 2017 Feb 9.
citation: Martin-Maria N, Miret M, Caballero FF, Rico-Uribe LA, Steptoe A, Chatterji S, Ayuso-Mateos JL. The Impact of Subjective Well-being on Mortality: A Meta-Analysis of Longitudinal Studies in the General Population. Psychosom Med. 2017 Jun;79(5):565-575. doi: 10.1097/PSY.0000000000000444.
citation: Lara E, Koyanagi A, Caballero F, Domenech-Abella J, Miret M, Olaya B, Rico-Uribe L, Ayuso-Mateos JL, Haro JM. Cognitive reserve is associated with quality of life: A population-based study. Exp Gerontol. 2017 Jan;87(Pt A):67-73. doi: 10.1016/j.exger.2016.10.012. Epub 2016 Nov 5.
citation: Kamenov K, Caballero FF, Miret M, Leonardi M, Sainio P, Tobiasz-Adamczyk B, Haro JM, Chatterji S, Ayuso-Mateos JL, Cabello M. Which Are the Most Burdensome Functioning Areas in Depression? A Cross-National Study. Front Psychol. 2016 Aug 31;7:1342. doi: 10.3389/fpsyg.2016.01342. eCollection 2016.
citation: Martin-Maria N, Caballero FF, Olaya B, Rodriguez-Artalejo F, Haro JM, Miret M, Ayuso-Mateos JL. Positive Affect Is Inversely Associated with Mortality in Individuals without Depression. Front Psychol. 2016 Jul 12;7:1040. doi: 10.3389/fpsyg.2016.01040. eCollection 2016.
citation: Raggi A, Corso B, Minicuci N, Quintas R, Sattin D, De Torres L, Chatterji S, Frisoni GB, Haro JM, Koskinen S, Martinuzzi A, Miret M, Tobiasz-Adamczyk B, Leonardi M. Determinants of Quality of Life in Ageing Populations: Results from a Cross-Sectional Study in Finland, Poland and Spain. PLoS One. 2016 Jul 19;11(7):e0159293. doi: 10.1371/journal.pone.0159293. eCollection 2016.
citation: Tyrovolas S, Koyanagi A, Olaya B, Ayuso-Mateos JL, Miret M, Chatterji S, Tobiasz-Adamczyk B, Koskinen S, Leonardi M, Haro JM. Factors associated with skeletal muscle mass, sarcopenia, and sarcopenic obesity in older adults: a multi-continent study. J Cachexia Sarcopenia Muscle. 2016 Jun;7(3):312-21. doi: 10.1002/jcsm.12076. Epub 2015 Oct 7.
citation: Lara E, Koyanagi A, Olaya B, Lobo A, Miret M, Tyrovolas S, Ayuso-Mateos JL, Haro JM. Mild cognitive impairment in a Spanish representative sample: prevalence and associated factors. Int J Geriatr Psychiatry. 2016 Aug;31(8):858-67. doi: 10.1002/gps.4398. Epub 2016 Feb 28.
citation: Olaya B, Moneta MV, Koyanagi A, Lara E, Miret M, Ayuso-Mateos JL, Chatterji S, Leonardi M, Koskinen S, Tobiasz-Adamczyk B, Lobo A, Haro JM. The joint association of depression and cognitive function with severe disability among community-dwelling older adults in Finland, Poland and Spain. Exp Gerontol. 2016 Apr;76:39-45. doi: 10.1016/j.exger.2016.01.010. Epub 2016 Jan 22.
citation: Rico-Uribe LA, Caballero FF, Olaya B, Tobiasz-Adamczyk B, Koskinen S, Leonardi M, Haro JM, Chatterji S, Ayuso-Mateos JL, Miret M. Loneliness, Social Networks, and Health: A Cross-Sectional Study in Three Countries. PLoS One. 2016 Jan 13;11(1):e0145264. doi: 10.1371/journal.pone.0145264. eCollection 2016.
citation: Tyrovolas S, Koyanagi A, Olaya B, Ayuso-Mateos JL, Miret M, Chatterji S, Tobiasz-Adamczyk B, Koskinen S, Leonardi M, Haro JM. The role of muscle mass and body fat on disability among older adults: A cross-national analysis. Exp Gerontol. 2015 Sep;69:27-35. doi: 10.1016/j.exger.2015.06.002. Epub 2015 Jun 3.
citation: Koyanagi A, Stickley A, Garin N, Miret M, Ayuso-Mateos JL, Leonardi M, Koskinen S, Galas A, Haro JM. The association between obesity and back pain in nine countries: a cross-sectional study. BMC Public Health. 2015 Feb 11;15:123. doi: 10.1186/s12889-015-1362-9.
citation: Tyrovolas S, Koyanagi A, Garin N, Olaya B, Ayuso-Mateos JL, Miret M, Chatterji S, Tobiasz-Adamczyk B, Koskinen S, Leonardi M, Haro JM. Diabetes mellitus and its association with central obesity and disability among older adults: a global perspective. Exp Gerontol. 2015 Apr;64:70-7. doi: 10.1016/j.exger.2015.02.010. Epub 2015 Feb 16.
citation: Tyrovolas S, Koyanagi A, Garin N, Olaya B, Ayuso-Mateos JL, Miret M, Chatterji S, Tobiasz-Adamczyk B, Koskinen S, Leonardi M, Haro JM. Determinants of the components of arterial pressure among older adults--the role of anthropometric and clinical factors: a multi-continent study. Atherosclerosis. 2015 Feb;238(2):240-9. doi: 10.1016/j.atherosclerosis.2014.11.029. Epub 2014 Dec 9.
citation: Miret M, Caballero FF, Chatterji S, Olaya B, Tobiasz-Adamczyk B, Koskinen S, Leonardi M, Haro JM, Ayuso-Mateos JL. Health and happiness: cross-sectional household surveys in Finland, Poland and Spain. Bull World Health Organ. 2014 Oct 1;92(10):716-25. doi: 10.2471/BLT.13.129254. Epub 2014 Aug 13.
citation: Garin N, Olaya B, Moneta MV, Miret M, Lobo A, Ayuso-Mateos JL, Haro JM. Impact of multimorbidity on disability and quality of life in the Spanish older population. PLoS One. 2014 Nov 6;9(11):e111498. doi: 10.1371/journal.pone.0111498. eCollection 2014.
citation: Garin N, Olaya B, Miret M, Ayuso-Mateos JL, Power M, Bucciarelli P, Haro JM. Built environment and elderly population health: a comprehensive literature review. Clin Pract Epidemiol Ment Health. 2014 Oct 21;10:103-15. doi: 10.2174/1745017901410010103. eCollection 2014.
citation: Lara E, Olaya B, Garin N, Ayuso-Mateos JL, Miret M, Moneta V, Haro JM. Is cognitive impairment associated with suicidality? A population-based study. Eur Neuropsychopharmacol. 2015 Feb;25(2):203-13. doi: 10.1016/j.euroneuro.2014.08.010. Epub 2014 Aug 21.
citation: Garin N, Olaya B, Lara E, Moneta MV, Miret M, Ayuso-Mateos JL, Haro JM. Visual impairment and multimorbidity in a representative sample of the Spanish population. BMC Public Health. 2014 Aug 8;14:815. doi: 10.1186/1471-2458-14-815.
citation: Miret M, Caballero FF, Huerta-Ramirez R, Moneta MV, Olaya B, Chatterji S, Haro JM, Ayuso-Mateos JL. Factors associated with suicidal ideation and attempts in Spain for different age groups. Prevalence before and after the onset of the economic crisis. J Affect Disord. 2014 Jul;163:1-9. doi: 10.1016/j.jad.2014.03.045. Epub 2014 Apr 1.
citation: Quintas R, Raggi A, Bucciarelli P, Franco MG, Andreotti A, Caballero FF, Olaya B, Chatterji S, Galas A, Merilainen-Porras S, Frisoni G, Russo E, Minicuci N, Power M, Leonardi M. The COURAGE Built Environment Outdoor Checklist: an objective built environment instrument to investigate the impact of the environment on health and disability. Clin Psychol Psychother. 2014 May-Jun;21(3):204-14. doi: 10.1002/cpp.1858. Epub 2013 Jul 29.
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citation: Caballero FF, Miret M, Power M, Chatterji S, Tobiasz-Adamczyk B, Koskinen S, Leonardi M, Olaya B, Haro JM, Ayuso-Mateos JL. Validation of an instrument to evaluate quality of life in the aging population: WHOQOL-AGE. Health Qual Life Outcomes. 2013 Oct 23;11:177. doi: 10.1186/1477-7525-11-177.
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citation: Domenech-Abella J, Lara E, Rubio-Valera M, Olaya B, Moneta MV, Rico-Uribe LA, Ayuso-Mateos JL, Mundo J, Haro JM. Loneliness and depression in the elderly: the role of social network. Soc Psychiatry Psychiatr Epidemiol. 2017 Apr;52(4):381-390. doi: 10.1007/s00127-017-1339-3. Epub 2017 Feb 2.
citation: Olaya B, Moneta MV, Miret M, Ayuso-Mateos JL, Haro JM. Epidemiology of panic attacks, panic disorder and the moderating role of age: Results from a population-based study. J Affect Disord. 2018 Dec 1;241:627-633. doi: 10.1016/j.jad.2018.08.069. Epub 2018 Aug 16.
citation: Olaya B, Moneta MV, Lara E, Miret M, Martin-Maria N, Moreno-Agostino D, Ayuso-Mateos JL, Abduljabbar AS, Haro JM. Fruit and Vegetable Consumption and Potential Moderators Associated with All-Cause Mortality in a Representative Sample of Spanish Older Adults. Nutrients. 2019 Aug 2;11(8):1794. doi: 10.3390/nu11081794.
citation: Lara E, Caballero FF, Rico-Uribe LA, Olaya B, Haro JM, Ayuso-Mateos JL, Miret M. Are loneliness and social isolation associated with cognitive decline? Int J Geriatr Psychiatry. 2019 Nov;34(11):1613-1622. doi: 10.1002/gps.5174. Epub 2019 Jul 25.
citation: Martin-Maria N, Caballero FF, Moreno-Agostino D, Olaya B, Haro JM, Ayuso-Mateos JL, Miret M. Relationship between subjective well-being and healthy lifestyle behaviours in older adults: a longitudinal study. Aging Ment Health. 2020 Apr;24(4):611-619. doi: 10.1080/13607863.2018.1548567. Epub 2018 Dec 28.
citation: Cabello M, Borges G, Lara E, Olaya B, Martin-Maria N, Moreno-Agostino D, Miret M, Caballero FF, Haro JM, Ayuso-Mateos JL. The relationship between all-cause mortality and depression in different gender and age groups of the Spanish population. J Affect Disord. 2020 Apr 1;266:424-428. doi: 10.1016/j.jad.2020.01.162. Epub 2020 Jan 28.
citation: Ayuso-Mateos JL, Morillo D, Haro JM, Olaya B, Lara E, Miret M. Changes in depression and suicidal ideation under severe lockdown restrictions during the first wave of the COVID-19 pandemic in Spain: a longitudinal study in the general population. Epidemiol Psychiatr Sci. 2021 Jun 2;30:e49. doi: 10.1017/S2045796021000408.
citation: Lara E, Martin-Maria N, Miret M, Olaya B, Haro JM, Ayuso-Mateos JL. Is there a combined effect of depression and cognitive reserve on cognitive function? Findings from a population-based study. Psychol Health. 2022 Sep;37(9):1132-1147. doi: 10.1080/08870446.2021.1927030. Epub 2021 May 24.
citation: Castelletti C, Lara E, Tobiasz-Adamczyk B, Koskinen S, Olaya B, Haro JM, Leonardi M, Kowal P, Chatterji S, Ayuso-Mateos JL, Miret M. Connecting and feeling: Associations between social factors and emotions in nine countries. Int J Psychol. 2023 Jun;58(3):282-291. doi: 10.1002/ijop.12892. Epub 2023 Feb 2.