DESVELA Cohort. Analysis of the Role of Personal Skills as Determinants of Incidence of Morbidity, Lifestyles, Quality of Life, Use of Services and Mortality.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,260
- 试验地点
- 20
- 主要终点
- Incidence of morbidity.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Population ascribed to Primary Health Centres in Spain.
排除标准
- •Illness at terminal phase.
- •Institutionalization.
- •Intellectual disability.
- •Dementia.
- •Idiomatic difficulties
结局指标
主要结局
Incidence of morbidity.
时间窗: 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.
Mortality from all causes
时间窗: Ten years
Mortality and its causes will be known by checking health care records.
Self-reported adherence to Mediterranean diet (PREDIMED scale)
时间窗: 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)
Self-reported physical activity (Validated questionnaire)
时间窗: 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);
Self-reported quality of of life
时间窗: 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).
Insomnia assessment
时间窗: 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).
Tobacco Consumption
时间窗: Ten years
Tobacco consumption, 4-question scale adapted from the WHO MONICA Study
Alcohol consumption
时间窗: 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)
Health service use
时间窗: Ten years
Use of health services will be recorded from the health electronic records of each participant.
次要结局
未报告次要终点