DESVELA. Personal Skills as Determinants of Morbidity, Lifestyles, Quality of Life, Use of Services and Mortality. (DESVELA)

January 29, 2024 updated by: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

DESVELA Cohort. Analysis of the Role of Personal Skills as Determinants of Incidence of Morbidity, Lifestyles, Quality of Life, Use of Services and Mortality.

Quantitative study: The main objective is to analyze whether personal skills related to behaviours are independently associated with the incidence of morbidity. Study with quantitative and qualitative methodology. Multicenter project (10 teams) for the creation of a cohort of 3083 people aged 35 to 74 years of 9 Autonomous Communities (AACC). The personal variables that will be evaluated are: self-efficacy, activation, health literacy, resilience, locus of control and personality traits. Socio-demographic covariates, social capital and community health assets will be recorded. As a secondary objective, it will be analyzed whether personal skills are independently associated with lower all cause mortality, better adoption of healthy lifestyles, higher quality of life and less utilization of health services in follow-up. A physical examination, a blood analytical and a cognitive evaluation will be carried out. The incidence of morbidity will be analyzed with a Cox model for each of the six independent variables (objective 1); and mortality from all causes and from the other dependent variables (objective 2). The models will be adjusted by the indicated covariables. The possible heterogeneity between (AACC) will be estimated by introducing random effects into the model.

Qualitative study: To deepen in the opinions and experiences of the population on the relationship between personal skills with their perception of health, their lifestyles and their quality of life. The research will be carried out from a phenomenological perspective. The number of discussion groups needed to reach the saturation of speeches will be made. There will be an analysis of thematic content that will be triangulated between members of the research team. The meanings will be interpreted and an explanatory framework will be created with the contributions of each type of informant.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

3260

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
      • Cuenca, Spain, 16002
        • Centro de Salud Cuenca 1, Calle Colón 2.
      • Girona, Spain, 17003
        • Unidad de Investigación en Atención Primaria de Girona, IDIAP Jordi Gol, Institut Català de la Salut
      • Salamanca, Spain, 37005
        • Centro de Salud San Juan. Avda. de Portugal, 83-89.
      • Zaragoza, Spain, 50015
        • CS Arrabal, C/Andador Aragüés del Puerto, 3.
    • Andalucía
      • Dos Hermanas, Andalucía, Spain, 41089
        • Centro de Salud Olivar de Quintos.
    • Balears
      • Ferreries, Balears, Spain, 07750
        • Centro de Salud de Ferreries, Bisbe Severo, 3.
      • Manacor, Balears, Spain, 07500
        • Centro de Salud de Manacor, C/d'En Simó Tort, 19.
    • Barcelona
      • Cornellà de Llobregat, Barcelona, Spain, 08940
        • CAP Cornellà SDPI, La Gavarra. Carrer de Bellaterra, 41.
      • Cornellà de Llobregat, Barcelona, Spain, 08940
        • CAP Sant Ildefons. Avinguda de la República Argentina, S/N.
      • Gavà, Barcelona, Spain, 08850
        • CAP Dr. Bartomeu Fabrés Anglada Gava 2. Carrer de la Riera de les Parets, 7.
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08902
        • CAP Alhambra. Carrer de l'Alhambra, 20.
    • Bizkaia
      • Bilbao, Bizkaia, Spain, 48014
        • Centro de Salud de Deusto, Luis Power, 18.
    • Orense
      • Leiro, Orense, Spain, 32420
        • Centro de Salud de Leiro, C/Gabino Bugallal S/N.
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36202
        • Centro de Salud Beiramar, AV. da Beiramar, 51.
    • Salamanca
      • Guijuelo, Salamanca, Spain, 37770
        • Centro de Salud Guijuelo. C/ Teso de La Feria, S/N.
      • Linares de Riofrío., Salamanca, Spain, 37760
        • Centro de Salud Linares de Riofrío. Ctra. de Guijuelo, S/N.
    • Valladolid
      • Peñafiel., Valladolid, Spain, 47300
        • Centro de Salud Peñafiel. Carrer Cruz Roja, S/N.
      • Tudela De Duero., Valladolid, Spain, 47320
        • Centro de Salud Tudela de Duero. C/ María Zambrano, S/N.
      • Valladolid., Valladolid, Spain, 47010
        • Centro de Salud San Pablo. C/ Cardenal Torquemada, S/N.
    • Zaragoza
      • Daroca, Zaragoza, Spain, 50360
        • CS Daroca. C/Luchente S/N

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

35 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Population adscrited to Primary Health Centres in Spain

Description

Inclusion Criteria:

- Population ascribed to Primary Health Centres in Spain.

Exclusion Criteria:

  • Illness at terminal phase.
  • Institutionalization.
  • Intellectual disability.
  • Dementia.
  • Idiomatic difficulties

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of morbidity.
Time Frame: Five years
The following pathologies will be considered in the evaluation of morbidity. 1) hypertension (HTA) 2) ischemic heart disease 3) heart failure 4) cardiac arrhythmias 5) diabetes mellitus (DM) 6) ischemic stroke 7) peripheral artery disease (PAD) 8) chronic obstructive pulmonary disease 9) asthma 10) any type of arthritis 11) osteoporosis 12) any type of cancer 13) Parkinson's disease 14) affective disorders 15) psychotic disorders 16) dementia 17) obesity. The appearance of a new condition in the clinical health history (CHI) in the follow-up, in relation to the ones it had in the baseline, will be considered. But in 4 cases, information of the physical exploration will be also considered. - HTA: in CHI or treatment for hypertension or systolic blood pressure ≥140 mmHg or Diastolic BP ≥90 mmHg. - DM: in CHI or treatment for diabetes or fasting glucose ≥ 126 mg/dL. - PAD: in CHI or ankle-brachial index <0.9.- Obesity: in CHI or body mass index: weight/ height2 is ≥30 kg/m2.
Five years
Incidence of morbidity.
Time Frame: Ten years
The following pathologies will be considered in the evaluation of morbidity. 1) hypertension (HTA) 2) ischemic heart disease 3) heart failure 4) cardiac arrhythmias 5) diabetes mellitus (DM) 6) ischemic stroke 7) peripheral artery disease (PAD) 8) chronic obstructive pulmonary disease 9) asthma 10) any type of arthritis 11) osteoporosis 12) any type of cancer 13) Parkinson's disease 14) affective disorders 15) psychotic disorders 16) dementia 17) obesity. The appearance of a new condition in the clinical health history (CHI) in the follow-up, in relation to the ones it had in the baseline, will be considered. But in 4 cases, information of the physical exploration will be also considered. - HTA: in CHI or treatment for hypertension or systolic blood pressure ≥140 mmHg or Diastolic BP ≥90 mmHg. - DM: in CHI or treatment for diabetes or fasting glucose ≥ 126 mg/dL. - PAD: in CHI or ankle-brachial index <0.9.- Obesity: in CHI or body mass index: weight/ height2 is ≥30 kg/m2.
Ten years
Mortality from all causes
Time Frame: Five years
Mortality and its causes will be known by checking health care records.
Five years
Mortality from all causes
Time Frame: Ten years
Mortality and its causes will be known by checking health care records.
Ten years
Self-reported adherence to Mediterranean diet (PREDIMED scale)
Time Frame: Five years
The questionnaire is validated in Spain in Spanish. Adherence to Mediterranean diet (PREDIMED; 0-14, higher values = higher adherence; ref: Martínez-González MA et al. (2012). PLoS One 7:e43134)
Five years
Self-reported adherence to Mediterranean diet (PREDIMED scale)
Time Frame: Ten years
The questionnaire is validated in Spain in Spanish. Adherence to Mediterranean diet (PREDIMED; 0-14, higher values = higher adherence; ref: Martínez-González MA et al. (2012). PLoS One 7:e43134)
Ten years
Self-reported physical activity (Validated questionnaire)
Time Frame: Ten years
Level of physical activity (higher score = higher level of PA, Physical activity expenditure is estimated in METs-hour-week; ref: Puig-Ribera A, et al. (2015). PLoS One 10:e0136870);
Ten years
Tobacco Consumption
Time Frame: Ten years
Tobacco consumption, 4-question scale adapted from the WHO MONICA Study
Ten years
Alcohol consumption
Time Frame: Five years
Alcohol consumption, will be assessed by self-reported units during the last week, and a question regarding the monthly frequency during the last year of excessive alcohol consumption (alcohol binge drinking)
Five years
Alcohol consumption
Time Frame: Ten years
Alcohol consumption, will be assessed by self-reported units during the last week, and a question regarding the monthly frequency during the last year of excessive alcohol consumption (alcohol binge drinking)
Ten years
Insomnia assessment
Time Frame: Ten years
Insomnia will be measured with the Pittsburgh Sleep Quality Index-PSQI; 0-21, Higher scores represent poorer subjective sleep quality; ref: Hita-Contreras, F. et al. (2014). Rheumatology International, 34(7), 929-936).
Ten years
Health service use
Time Frame: Five years
Use of health services will be recorded from the health electronic records of each participant.
Five years
Health service use
Time Frame: Ten years
Use of health services will be recorded from the health electronic records of each participant.
Ten years
Self-reported physical activity (Validated questionnaire)
Time Frame: Five years
Level of physical activity (higher score = higher level of PA, Physical activity expenditure is estimated in metabolic equivalent of task (MET) METs-hour-week; ref: Puig-Ribera A, et al. (2015). PLoS One 10:e0136870);
Five years
Tobacco Consumption
Time Frame: Five years
Tobacco consumption, 4-question scale adapted from the World Health Organization (WHO) MONICA Study
Five years
Insomnia assessment
Time Frame: Five years
Insomnia will be measured with the Pittsburgh Sleep Quality Index (PSQI); 0-21, Higher scores represent poorer subjective sleep quality; ref: Hita-Contreras, F. et al. (2014). Rheumatology International, 34(7), 929-936).
Five years
Self-reported quality of of life
Time Frame: Five years
Quality of life will be measured with EuroQol5D (number of dimensions with problems) + EVA (0-100, higher value higher perception of quality of life); ref: Herdman M, et al. (2015). Aten Primaria 28(6): 425-9).
Five years
Self-reported quality of of life
Time Frame: Ten years
Quality of life will be measured with EuroQol 5D (number of dimensions with problems) + visual analogue scale (VAS) (0-100, higher value higher perception of quality of life); ref: Herdman M, et al. (2015). Aten Primaria 28(6): 425-9).
Ten years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Collaborators

Fundació d'investigació Sanitària de les Illes Balears
Fundació Sant Joan de Déu
Parc Sanitari Sant Joan de Déu
Institut Català de la Salut
Andaluz Health Service
Preventive Services and Health Promotion Research Network
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Instituto de Salud Carlos III
Osakidetza
Castilla-La Mancha Health Service
Public Health Service of Galicia
University of Castilla-La Mancha
Fundacin Biomedica Galicia Sur
Biocruces Bizkaia Health Research Institute
Instituto de Investigación Sanitaria Aragón
Servei de Salut de les Illes Balears
Servicio Aragones De Salud
Universidad Loyola Andalucia

Investigators

  • Study Chair: Bonaventura Bolíbar, IDIAP Jordi Gol
  • Study Director: Rafel Ramos, PhD, IDIAP Jordi Gol
  • Principal Investigator: Ruth Martí-Lluch, PhD, IDIAP Jordi Gol

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

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)

June 12, 2021

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 30, 2020

First Submitted That Met QC Criteria

May 8, 2020

First Posted (Actual)

May 13, 2020

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 4R19/112
  • PI19/01285 (Other Grant/Funding Number: Instituto de Salud Carlos III.)
  • PI19/00147 (Other Grant/Funding Number: Instituto de Salud Carlos III.)
  • PI19/01459 (Other Grant/Funding Number: Instituto de Salud Carlos III.)
  • PI19/00997 (Other Grant/Funding Number: Instituto de Salud Carlos III.)
  • PI19/00115 (Other Grant/Funding Number: Instituto de Salud Carlos III.)
  • PI19/01140 (Other Grant/Funding Number: Instituto de Salud Carlos III.)
  • PI19/01264 (Other Grant/Funding Number: Instituto de Salud Carlos III.)
  • PI19/00434 (Other Grant/Funding Number: Instituto de Salud Carlos III.)
  • PI19/01314 (Other Grant/Funding Number: Instituto de Salud Carlos III.)
  • PI19/01076 (Other Grant/Funding Number: Instituto de Salud Carlos III.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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