Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-24 @ 10:07 PM
NCT ID:
NCT04386135
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.
Study:
NCT04386135
Study Brief:
Protocol Section:
NCT04386135