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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

20 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 13, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 12, 2021

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

4.5 years

First QC Date

April 30, 2020

Last Update Submit

January 29, 2024

Conditions

General PopulationHealth Knowledge, Attitudes, PracticeEmpowermentHealth Care UtilizationLife StyleSelf EfficacyActivation, PatientLocus of ControlQuality of Life

Keywords

Primary Health CareHealth PromotionQuality of LifeLife StyleHealth LiteracyEmpowermentLocus of ControlPersonalitySelf Efficacy

Outcome Measures

Primary Outcomes (18)

  • 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

Eligibility Criteria

Age35 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Population adscrited to Primary Health Centres in Spain

You may qualify if:

  • \- Population ascribed to Primary Health Centres in Spain.

You may not qualify if:

  • Illness at terminal phase.
  • Institutionalization.
  • Intellectual disability.
  • Dementia.
  • Idiomatic difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Centro de Salud Olivar de Quintos.

Dos Hermanas, Andalusia, 41089, Spain

Location

Centro de Salud de Ferreries, Bisbe Severo, 3.

Ferreries, Balearic Islands, 07750, Spain

Location

Centro de Salud de Manacor, C/d'En Simó Tort, 19.

Manacor, Balearic Islands, 07500, Spain

Location

CAP Cornellà SDPI, La Gavarra. Carrer de Bellaterra, 41.

Cornellà de Llobregat, Barcelona, 08940, Spain

Location

CAP Sant Ildefons. Avinguda de la República Argentina, S/N.

Cornellà de Llobregat, Barcelona, 08940, Spain

Location

CAP Dr. Bartomeu Fabrés Anglada Gava 2. Carrer de la Riera de les Parets, 7.

Gavà, Barcelona, 08850, Spain

Location

CAP Alhambra. Carrer de l'Alhambra, 20.

L'Hospitalet de Llobregat, Barcelona, 08902, Spain

Location

Centro de Salud de Deusto, Luis Power, 18.

Bilbao, Bizkaia, 48014, Spain

Location

Centro de Salud de Leiro, C/Gabino Bugallal S/N.

Leiro, Orense, 32420, Spain

Location

Centro de Salud Beiramar, AV. da Beiramar, 51.

Vigo, Pontevedra, 36202, Spain

Location

Centro de Salud Guijuelo. C/ Teso de La Feria, S/N.

Guijuelo, Salamanca, 37770, Spain

Location

Centro de Salud Linares de Riofrío. Ctra. de Guijuelo, S/N.

Linares de Riofrío, Salamanca, 37760, Spain

Location

Centro de Salud Peñafiel. Carrer Cruz Roja, S/N.

Peñafiel, Valladolid, 47300, Spain

Location

Centro de Salud Tudela de Duero. C/ María Zambrano, S/N.

Tudela de Duero, Valladolid, 47320, Spain

Location

Centro de Salud San Pablo. C/ Cardenal Torquemada, S/N.

Valladolid, Valladolid, 47010, Spain

Location

CS Daroca. C/Luchente S/N

Daroca, Zaragoza, 50360, Spain

Location

Centro de Salud Cuenca 1, Calle Colón 2.

Cuenca, 16002, Spain

Location

Unidad de Investigación en Atención Primaria de Girona, IDIAP Jordi Gol, Institut Català de la Salut

Girona, 17003, Spain

Location

Centro de Salud San Juan. Avda. de Portugal, 83-89.

Salamanca, 37005, Spain

Location

CS Arrabal, C/Andador Aragüés del Puerto, 3.

Zaragoza, 50015, Spain

Location

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MeSH Terms

Conditions

BehaviorEmpowermentPatient Acceptance of Health CarePatient Participation

Condition Hierarchy (Ancestors)

Social BehaviorTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • Bonaventura Bolíbar

    Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    STUDY CHAIR

  • Rafel Ramos, PhD

    Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    STUDY DIRECTOR

  • Ruth Martí-Lluch, PhD

    Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2020

First Posted

May 13, 2020

Study Start

June 12, 2021

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

January 30, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(20)