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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000079102', 'term': 'Empowerment'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D010358', 'term': 'Patient Participation'}], 'ancestors': [{'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3260}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-29', 'studyFirstSubmitDate': '2020-04-30', 'studyFirstSubmitQcDate': '2020-05-08', 'lastUpdatePostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of morbidity.', 'timeFrame': 'Five years', 'description': "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."}, {'measure': 'Incidence of morbidity.', 'timeFrame': 'Ten years', 'description': "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."}, {'measure': 'Mortality from all causes', 'timeFrame': 'Five years', 'description': 'Mortality and its causes will be known by checking health care records.'}, {'measure': 'Mortality from all causes', 'timeFrame': 'Ten years', 'description': 'Mortality and its causes will be known by checking health care records.'}, {'measure': 'Self-reported adherence to Mediterranean diet (PREDIMED scale)', 'timeFrame': 'Five years', 'description': '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)'}, {'measure': 'Self-reported adherence to Mediterranean diet (PREDIMED scale)', 'timeFrame': 'Ten years', 'description': '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)'}, {'measure': 'Self-reported physical activity (Validated questionnaire)', 'timeFrame': 'Five years', 'description': '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);'}, {'measure': 'Self-reported physical activity (Validated questionnaire)', 'timeFrame': 'Ten years', 'description': '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);'}, {'measure': 'Tobacco Consumption', 'timeFrame': 'Five years', 'description': 'Tobacco consumption, 4-question scale adapted from the World Health Organization (WHO) MONICA Study'}, {'measure': 'Tobacco Consumption', 'timeFrame': 'Ten years', 'description': 'Tobacco consumption, 4-question scale adapted from the WHO MONICA Study'}, {'measure': 'Alcohol consumption', 'timeFrame': 'Five years', 'description': '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)'}, {'measure': 'Alcohol consumption', 'timeFrame': 'Ten years', 'description': '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)'}, {'measure': 'Insomnia assessment', 'timeFrame': 'Five years', 'description': '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).'}, {'measure': 'Insomnia assessment', 'timeFrame': 'Ten years', 'description': '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).'}, {'measure': 'Self-reported quality of of life', 'timeFrame': 'Five years', 'description': '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).'}, {'measure': 'Self-reported quality of of life', 'timeFrame': 'Ten years', 'description': '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).'}, {'measure': 'Health service use', 'timeFrame': 'Five years', 'description': 'Use of health services will be recorded from the health electronic records of each participant.'}, {'measure': 'Health service use', 'timeFrame': 'Ten years', 'description': 'Use of health services will be recorded from the health electronic records of each participant.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Primary Health Care', 'Health Promotion', 'Quality of Life', 'Life Style', 'Health Literacy', 'Empowerment', 'Locus of Control', 'Personality', 'Self Efficacy'], 'conditions': ['General Population', 'Health Knowledge, Attitudes, Practice', 'Empowerment', 'Health Care Utilization', 'Life Style', 'Self Efficacy', 'Activation, Patient', 'Locus of Control', 'Quality of Life']}, 'referencesModule': {'references': [{'pmid': '29987080', 'type': 'BACKGROUND', 'citation': 'Mounce LTA, Campbell JL, Henley WE, Tejerina Arreal MC, Porter I, Valderas JM. 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Exploring personal aptitudes and personality traits that, together with social determinants, shape health behaviors and conduct: a thematic analysis based on the Capability, Opportunity, Motivation and Behavior (COM-B) change system. Front Public Health. 2024 Jun 5;12:1387528. doi: 10.3389/fpubh.2024.1387528. eCollection 2024.'}, {'pmid': '37427254', 'type': 'DERIVED', 'citation': 'Marti-Lluch R, Bolibar B, Llobera J, Maderuelo-Fernandez JA, Magallon-Botaya R, Sanchez-Perez A, Fernandez-Dominguez MJ, Motrico E, Vicens-Pons E, Notario-Pacheco B, Alves-Cabratosa L, Ramos R; DESVELA Cohort Investigators. Role of personal aptitudes as determinants of incident morbidity, lifestyles, quality of life, use of health services, and mortality (DESVELA cohort): quantitative study protocol for a prospective cohort study in a hybrid analysis. Front Public Health. 2023 Jun 22;11:1067249. doi: 10.3389/fpubh.2023.1067249. eCollection 2023.'}, {'pmid': '37361167', 'type': 'DERIVED', 'citation': 'Young-Silva Y, Berenguera A, Jacques-Avino C, Gil-Girbau M, Arroyo-Uriarte P, Chela-Alvarez X, Ripoll J, Marti-Lluch R, Ramos R, Elizondo-Alzola U, Garcia-Martinez S, Mendez-Lopez F, Tamayo-Morales O, Martinez-Andres M, Motrico E, Gomez-Gomez I, Fernandez-Alvarez R, Juvinya-Canal D; DESVELA Cohort investigators. Role of personal aptitudes as determinants of incident morbidity, lifestyles, quality of life, use of the health services and mortality (DESVELA cohort): qualitative study protocol for a prospective cohort study in a hybrid analysis. Front Public Health. 2023 Jun 9;11:1069957. doi: 10.3389/fpubh.2023.1069957. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nQualitative 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '35 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Population adscrited to Primary Health Centres in Spain', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Population ascribed to Primary Health Centres in Spain.\n\nExclusion Criteria:\n\n* Illness at terminal phase.\n* Institutionalization.\n* Intellectual disability.\n* Dementia.\n* Idiomatic difficulties'}, 'identificationModule': {'nctId': 'NCT04386135', 'acronym': 'DESVELA', 'briefTitle': 'DESVELA. Personal Skills as Determinants of Morbidity, Lifestyles, Quality of Life, Use of Services and Mortality.', 'organization': {'class': 'OTHER', 'fullName': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina"}, 'officialTitle': 'DESVELA Cohort. Analysis of the Role of Personal Skills as Determinants of Incidence of Morbidity, Lifestyles, Quality of Life, Use of Services and Mortality.', 'orgStudyIdInfo': {'id': '4R19/112'}, 'secondaryIdInfos': [{'id': 'PI19/01285', 'type': 'OTHER_GRANT', 'domain': 'Instituto de Salud Carlos III.'}, {'id': 'PI19/00147', 'type': 'OTHER_GRANT', 'domain': 'Instituto de Salud Carlos III.'}, {'id': 'PI19/01459', 'type': 'OTHER_GRANT', 'domain': 'Instituto de Salud Carlos III.'}, {'id': 'PI19/00997', 'type': 'OTHER_GRANT', 'domain': 'Instituto de Salud Carlos III.'}, {'id': 'PI19/00115', 'type': 'OTHER_GRANT', 'domain': 'Instituto de Salud Carlos III.'}, {'id': 'PI19/01140', 'type': 'OTHER_GRANT', 'domain': 'Instituto de Salud Carlos III.'}, {'id': 'PI19/01264', 'type': 'OTHER_GRANT', 'domain': 'Instituto de Salud Carlos III.'}, {'id': 'PI19/00434', 'type': 'OTHER_GRANT', 'domain': 'Instituto de Salud Carlos III.'}, {'id': 'PI19/01314', 'type': 'OTHER_GRANT', 'domain': 'Instituto de Salud Carlos III.'}, {'id': 'PI19/01076', 'type': 'OTHER_GRANT', 'domain': 'Instituto de Salud Carlos III.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '41089', 'city': 'Dos Hermanas', 'state': 'Andalusia', 'country': 'Spain', 'facility': 'Centro de Salud Olivar de Quintos.', 'geoPoint': {'lat': 37.28287, 'lon': -5.92088}}, {'zip': '07750', 'city': 'Ferreries', 'state': 'Balearic Islands', 'country': 'Spain', 'facility': 'Centro de Salud de Ferreries, Bisbe Severo, 3.', 'geoPoint': {'lat': 39.98324, 'lon': 4.01181}}, {'zip': '07500', 'city': 'Manacor', 'state': 'Balearic Islands', 'country': 'Spain', 'facility': "Centro de Salud de Manacor, C/d'En Simó Tort, 19.", 'geoPoint': {'lat': 39.56964, 'lon': 3.20955}}, {'zip': '08940', 'city': 'Cornellà de Llobregat', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'CAP Cornellà SDPI, La Gavarra. Carrer de Bellaterra, 41.', 'geoPoint': {'lat': 41.35, 'lon': 2.08333}}, {'zip': '08940', 'city': 'Cornellà de Llobregat', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'CAP Sant Ildefons. Avinguda de la República Argentina, S/N.', 'geoPoint': {'lat': 41.35, 'lon': 2.08333}}, {'zip': '08850', 'city': 'Gavà', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'CAP Dr. Bartomeu Fabrés Anglada Gava 2. Carrer de la Riera de les Parets, 7.', 'geoPoint': {'lat': 41.30605, 'lon': 2.00123}}, {'zip': '08902', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'country': 'Spain', 'facility': "CAP Alhambra. Carrer de l'Alhambra, 20.", 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '48014', 'city': 'Bilbao', 'state': 'Bizkaia', 'country': 'Spain', 'facility': 'Centro de Salud de Deusto, Luis Power, 18.', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'zip': '32420', 'city': 'Leiro', 'state': 'Orense', 'country': 'Spain', 'facility': 'Centro de Salud de Leiro, C/Gabino Bugallal S/N.', 'geoPoint': {'lat': 43.35, 'lon': -8.18333}}, {'zip': '36202', 'city': 'Vigo', 'state': 'Pontevedra', 'country': 'Spain', 'facility': 'Centro de Salud Beiramar, AV. da Beiramar, 51.', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'zip': '37770', 'city': 'Guijuelo', 'state': 'Salamanca', 'country': 'Spain', 'facility': 'Centro de Salud Guijuelo. C/ Teso de La Feria, S/N.', 'geoPoint': {'lat': 40.55757, 'lon': -5.67067}}, {'zip': '37760', 'city': 'Linares de Riofrío', 'state': 'Salamanca', 'country': 'Spain', 'facility': 'Centro de Salud Linares de Riofrío. Ctra. de Guijuelo, S/N.', 'geoPoint': {'lat': 40.58338, 'lon': -5.92091}}, {'zip': '47300', 'city': 'Peñafiel', 'state': 'Valladolid', 'country': 'Spain', 'facility': 'Centro de Salud Peñafiel. Carrer Cruz Roja, S/N.', 'geoPoint': {'lat': 41.60165, 'lon': -4.11418}}, {'zip': '47320', 'city': 'Tudela de Duero', 'state': 'Valladolid', 'country': 'Spain', 'facility': 'Centro de Salud Tudela de Duero. C/ María Zambrano, S/N.', 'geoPoint': {'lat': 41.5845, 'lon': -4.58093}}, {'zip': '47010', 'city': 'Valladolid', 'state': 'Valladolid', 'country': 'Spain', 'facility': 'Centro de Salud San Pablo. C/ Cardenal Torquemada, S/N.', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'zip': '50360', 'city': 'Daroca', 'state': 'Zaragoza', 'country': 'Spain', 'facility': 'CS Daroca. C/Luchente S/N', 'geoPoint': {'lat': 41.11475, 'lon': -1.41492}}, {'zip': '16002', 'city': 'Cuenca', 'country': 'Spain', 'facility': 'Centro de Salud Cuenca 1, Calle Colón 2.', 'geoPoint': {'lat': 40.06667, 'lon': -2.13333}}, {'zip': '17003', 'city': 'Girona', 'country': 'Spain', 'facility': 'Unidad de Investigación en Atención Primaria de Girona, IDIAP Jordi Gol, Institut Català de la Salut', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'zip': '37005', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Centro de Salud San Juan. Avda. de Portugal, 83-89.', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': '50015', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'CS Arrabal, C/Andador Aragüés del Puerto, 3.', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'Bonaventura Bolíbar', 'role': 'STUDY_CHAIR', 'affiliation': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina"}, {'name': 'Rafel Ramos, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina"}, {'name': 'Ruth Martí-Lluch, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina", 'class': 'OTHER'}, 'collaborators': [{'name': 'Preventive Services and Health Promotion Research Network', 'class': 'OTHER'}, {'name': 'Instituto de Salud Carlos III', 'class': 'OTHER_GOV'}, {'name': 'Parc Sanitari Sant Joan de Déu', 'class': 'OTHER'}, {'name': 'Servei de Salut de les Illes Balears', 'class': 'UNKNOWN'}, {'name': 'Institut Català de la Salut', 'class': 'OTHER'}, {'name': 'Servicio Aragones De Salud', 'class': 'OTHER'}, {'name': 'Osakidetza', 'class': 'OTHER'}, {'name': 'Andaluz Health Service', 'class': 'OTHER_GOV'}, {'name': 'Castilla-La Mancha Health Service', 'class': 'OTHER'}, {'name': 'Biocruces Bizkaia Health Research Institute', 'class': 'OTHER_GOV'}, {'name': 'Fundació Sant Joan de Déu', 'class': 'OTHER'}, {'name': 'Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León', 'class': 'OTHER'}, {'name': 'Universidad Loyola Andalucia', 'class': 'OTHER'}, {'name': 'University of Castilla-La Mancha', 'class': 'OTHER'}, {'name': 'Instituto de Investigación Sanitaria Aragón', 'class': 'OTHER'}, {'name': "Fundació d'investigació Sanitària de les Illes Balears", 'class': 'OTHER_GOV'}, {'name': 'Fundacin Biomedica Galicia Sur', 'class': 'OTHER'}, {'name': 'Public Health Service of Galicia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}