Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-02-27 @ 4:05 PM
Study NCT ID:
NCT04386135
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-30
First Post:
2020-04-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DESVELA. Personal Skills as Determinants of Morbidity, Lifestyles, Quality of Life, Use of Services and Mortality.
Sponsor:
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Organization:
Study Overview
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.
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DESVELA
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| PI19/01285 | OTHER_GRANT | Instituto de Salud Carlos III. | View | |
| PI19/00147 | OTHER_GRANT | Instituto de Salud Carlos III. | View | |
| PI19/01459 | OTHER_GRANT | Instituto de Salud Carlos III. | View | |
| PI19/00997 | OTHER_GRANT | Instituto de Salud Carlos III. | View | |
| PI19/00115 | OTHER_GRANT | Instituto de Salud Carlos III. | View | |
| PI19/01140 | OTHER_GRANT | Instituto de Salud Carlos III. | View | |
| PI19/01264 | OTHER_GRANT | Instituto de Salud Carlos III. | View | |
| PI19/00434 | OTHER_GRANT | Instituto de Salud Carlos III. | View | |
| PI19/01314 | OTHER_GRANT | Instituto de Salud Carlos III. | View | |
| PI19/01076 | OTHER_GRANT | Instituto de Salud Carlos III. | View |