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

Quality of Life Clinical Trial

— DESVELA  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04386135
• Other study ID #: 4R19/112
• Secondary ID: PI19/01285PI19/0
• Status: Active, not recruiting
• Start date: June 12, 2021
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3260
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 74 Years

Eligibility

Inclusion Criteria:

• Population ascribed to Primary Health Centres in Spain.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Activation, Patient
• Empowerment
• General Population
• Health Care Utilization
• Health Knowledge, Attitudes, Practice
• Life Style
• Locus of Control
• Quality of Life
• Self Efficacy

Locations

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

Sponsors (19)

Lead Sponsor

Collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

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

Country where clinical trial is conducted

Spain, 

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* Note: There are 67 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Five years
Primary	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.	Ten years
Primary	Mortality from all causes	Mortality and its causes will be known by checking health care records.	Five years
Primary	Mortality from all causes	Mortality and its causes will be known by checking health care records.	Ten years
Primary	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)	Five years
Primary	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)	Ten years
Primary	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);	Five years
Primary	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);	Ten years
Primary	Tobacco Consumption	Tobacco consumption, 4-question scale adapted from the World Health Organization (WHO) MONICA Study	Five years
Primary	Tobacco Consumption	Tobacco consumption, 4-question scale adapted from the WHO MONICA Study	Ten years
Primary	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)	Five years
Primary	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)	Ten years
Primary	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).	Five years
Primary	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).	Ten years
Primary	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).	Five years
Primary	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).	Ten years
Primary	Health service use	Use of health services will be recorded from the health electronic records of each participant.	Five years
Primary	Health service use	Use of health services will be recorded from the health electronic records of each participant.	Ten years