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

Study Overview
=================
Brief 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.

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.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Population ascribed to Primary Health Centres in Spain. Exclusion Criteria: Illness at terminal phase. Institutionalization. Intellectual disability. Dementia. Idiomatic difficulties

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 74 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Health Care, Health Promotion, Quality of Life, Life Style, Health Literacy, Empowerment, Locus of Control, Personality, Self Efficacy