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General PopulationDESVELANCT04386135

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

An observational study of General Population and Health Knowledge, Attitudes, Practice, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 20 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 35 to 74 years
How many people
3,260 participants
Where
20 sitesSpain
Study dates
12 Jun 2021to Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Population adscrited to Primary Health Centres in Spain

Who may be able to join

  • Population ascribed to Primary Health Centres in Spain.

Who cannot join

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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Spain20 sites

  • Centro de Salud de Deusto, Luis Power, 18.

    Bilbao, Bizkaia, 48014

  • CAP Cornellà SDPI, La Gavarra. Carrer de Bellaterra, 41.

    Cornellà de Llobregat, Barcelona, 08940

  • CAP Sant Ildefons. Avinguda de la República Argentina, S/N.

    Cornellà de Llobregat, Barcelona, 08940

  • Centro de Salud Cuenca 1, Calle Colón 2.

    Cuenca, 16002

  • CS Daroca. C/Luchente S/N

    Daroca, Zaragoza, 50360

  • Centro de Salud Olivar de Quintos.

    Dos Hermanas, Andalusia, 41089

  • Centro de Salud de Ferreries, Bisbe Severo, 3.

    Ferreries, Balearic Islands, 07750

  • CAP Dr. Bartomeu Fabrés Anglada Gava 2. Carrer de la Riera de les Parets, 7.

    Gavà, Barcelona, 08850

  • Unidad de Investigación en Atención Primaria de Girona, IDIAP Jordi Gol, Institut Català de la Salut

    Girona, 17003

  • Centro de Salud Guijuelo. C/ Teso de La Feria, S/N.

    Guijuelo, Salamanca, 37770

  • CAP Alhambra. Carrer de l'Alhambra, 20.

    L'Hospitalet de Llobregat, Barcelona, 08902

  • Centro de Salud de Leiro, C/Gabino Bugallal S/N.

    Leiro, Orense, 32420

  • Centro de Salud Linares de Riofrío. Ctra. de Guijuelo, S/N.

    Linares de Riofrío, Salamanca, 37760

  • Centro de Salud de Manacor, C/d'En Simó Tort, 19.

    Manacor, Balearic Islands, 07500

  • Centro de Salud Peñafiel. Carrer Cruz Roja, S/N.

    Peñafiel, Valladolid, 47300

  • Centro de Salud San Juan. Avda. de Portugal, 83-89.

    Salamanca, 37005

  • Centro de Salud Tudela de Duero. C/ María Zambrano, S/N.

    Tudela de Duero, Valladolid, 47320

  • Centro de Salud San Pablo. C/ Cardenal Torquemada, S/N.

    Valladolid, Valladolid, 47010

  • Centro de Salud Beiramar, AV. da Beiramar, 51.

    Vigo, Pontevedra, 36202

  • CS Arrabal, C/Andador Aragüés del Puerto, 3.

    Zaragoza, 50015

Other trials in Spain

About this study

Official title: 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.

Keywords
Primary Health Care, Health Promotion, Quality of Life, Life Style, Health Literacy, Empowerment, Locus of Control, Personality, Self Efficacy
Medical subject headings
Behavior, Empowerment, Patient Acceptance of Health Care, Patient Participation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of morbidity.

    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.

    Measured: Five years

  2. Incidence of morbidity.

    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.

    Measured: Ten years

  3. Mortality from all causes

    Mortality and its causes will be known by checking health care records.

    Measured: Five years

  4. Mortality from all causes

    Mortality and its causes will be known by checking health care records.

    Measured: Ten years

  5. Self-reported adherence to Mediterranean diet (PREDIMED scale)

    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)

    Measured: Five years

  6. Self-reported adherence to Mediterranean diet (PREDIMED scale)

    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)

    Measured: Ten years

  7. Self-reported physical activity (Validated questionnaire)

    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);

    Measured: Five years

  8. Self-reported physical activity (Validated questionnaire)

    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);

    Measured: Ten years

  9. Tobacco Consumption

    Tobacco consumption, 4-question scale adapted from the World Health Organization (WHO) MONICA Study

    Measured: Five years

  10. Tobacco Consumption

    Tobacco consumption, 4-question scale adapted from the WHO MONICA Study

    Measured: Ten years

  11. Alcohol consumption

    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)

    Measured: Five years

  12. Alcohol consumption

    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)

    Measured: Ten years

  13. Insomnia assessment

    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).

    Measured: Five years

  14. Insomnia assessment

    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).

    Measured: Ten years

  15. Self-reported quality of of life

    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).

    Measured: Five years

  16. Self-reported quality of of life

    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).

    Measured: Ten years

  17. Health service use

    Use of health services will be recorded from the health electronic records of each participant.

    Measured: Five years

  18. Health service use

    Use of health services will be recorded from the health electronic records of each participant.

    Measured: Ten years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2020
  2. Study start12 Jun 2021
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,260 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04386135
Sponsor's protocol ID
4R19/112
Other IDs
PI19/01285, PI19/00147, PI19/01459, PI19/00997, PI19/00115, PI19/01140, PI19/01264, PI19/00434
Acronym
DESVELA
Status last verified
Jan 2024
First submitted
30 Apr 2020
Last updated
30 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mounce LTA, Campbell JL, Henley WE, Tejerina Arreal MC, Porter I, Valderas JM. Predicting Incident Multimorbidity. Ann Fam Med. 2018 Jul;16(4):322-329. doi: 10.1370/afm.2271.

    PubMed 29987080

  • Noncommunicable diseases country profiles 2018. Geneva: World Health Organization; 2018. Licence CC BY-NC-SA 3.0 IGO.

  • World Health Organization (WHO). Global status report on noncommunicable diseases 2014. Ginebra; 2014. ISBN 978 92 4 156422 8. [Internet]. Disponible en: http://www.who.int/nmh/publications/ncd_report_full_en.pdf.

  • Kessler RC, Aguilar-Gaxiola S, Alonso J, Chatterji S, Lee S, Ormel J, Ustun TB, Wang PS. The global burden of mental disorders: an update from the WHO World Mental Health (WMH) surveys. Epidemiol Psichiatr Soc. 2009 Jan-Mar;18(1):23-33. doi: 10.1017/s1121189x00001421.

    PubMed 19378696

  • O'Neil A, Jacka FN, Quirk SE, Cocker F, Taylor CB, Oldenburg B, Berk M. A shared framework for the common mental disorders and Non-Communicable Disease: key considerations for disease prevention and control. BMC Psychiatry. 2015 Feb 5;15:15. doi: 10.1186/s12888-015-0394-0.

    PubMed 25652365

  • Carta de Ottawa para la Promoción de la Salud, OMS, Ginebra, 1986. Who.int. (2015). WHO. [internet] Disponible en: http://www.who.int/healthpromotion/conferences/previous/ottawa/en/index1.html.

  • Gol i Gurina J. Els Grans Temes D'un Pensament I D'una Vida. Barcelona: La llar del llibre; 1986

  • Rosenzveig A, Kuspinar A, Daskalopoulou SS, Mayo NE. Toward patient-centered care: a systematic review of how to ask questions that matter to patients. Medicine (Baltimore). 2014 Nov;93(22):e120. doi: 10.1097/MD.0000000000000120.

    PubMed 25396331

  • Declaración de Yakarta, YAkarta, 1997. WHO. [internet] Disponible en: http://www.who.int/healthpromotion/conferences/previous/jakarta/en/hpr_jakarta_declaration_sp.pdf

  • Estrategia de promoción de la salud y prevención en el SNS. Madrid, 2013. MSSSI. Disponible en: https://www.msssi.gob.es/profesionales/saludPublica/prevPromocion/Estrategia/estrategiaPromocionyPrevencion.htm

  • Dahlgren G, Whitehead M. Policies and strategies to promote social equity in health. Stockholm: Institute for future studies; 1991. [internet]. Disponible en: https://core.ac.uk/download/pdf/6472456.pdf.

  • Antonovsky A. The salutogenic model as a theory to guide health promotion. Health Promotion International. 1996;11:11-18.

  • Marmot M. 2004. The Status Syndrome: How Social Standing Affects Our Health and Longevity. New York: Henry Holt.

  • Atkins L, Francis J, Islam R, O'Connor D, Patey A, Ivers N, Foy R, Duncan EM, Colquhoun H, Grimshaw JM, Lawton R, Michie S. A guide to using the Theoretical Domains Framework of behaviour change to investigate implementation problems. Implement Sci. 2017 Jun 21;12(1):77. doi: 10.1186/s13012-017-0605-9.

    PubMed 28637486

  • Rammstedt B, John OP. Measuring personality in one minute or less: A 10-item short version of the Big Five Inventory in English and German. J Res Pers. 2007; 41:203 -12.

Questions about this trial

What is this clinical trial studying?

An observational study of General Population and Health Knowledge, Attitudes, Practice, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 20 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of morbidity. (time frame: Five years). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04386135, which also lists 70 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.

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