NCT04151056

Brief Summary

The objective of this study is to increase the registry of social determinants of health in the primary care centers and evaluate the relationship that these social determinants of health with various variables of social impact.

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
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 23, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2021

Completed
Last Updated

June 23, 2020

Status Verified

July 1, 2019

Enrollment Period

1.7 years

First QC Date

October 31, 2019

Last Update Submit

June 22, 2020

Conditions

Social Determinants of HealthPrimary Health Care

Keywords

social determinants of health, reporting socials problems

Outcome Measures

Primary Outcomes (1)

  • Population Taxes

    In the descriptive basal analysis, the population taxes of all social diagnoses is going to be described.

    12 month

Secondary Outcomes (3)

  • Sociodemographic subcategories

    7 month

  • Comparison with the post-intervention data of the six diagnostics with Chi Quadrat Test.

    7 month

  • Social Impact. Parametric and non parametric test

    12 month

Study Arms (6)

Patients without social determinant of health

Patients without any of the five selected social determinants of health / Patients without any of the five selected social diagnosis. Patient with a registered diagnostic " Health check" (Z00.00)

Patients with the social determinant"stressful work hours"

Patients with the selected social determinant of health. Patients with a registered diagnostic "stressful work hours " (Z56.3)

Patients with the social determinant of health "living alone"

Patients with the select social determinant of health . Patients with the selected social determinant of health . Patients with a registered diagnostic " living alone problems" (Z60.2)

Patients with the social determinant of health "acculturation"

Patients with the selected social determinant of health. Patients with a registered diagnostic "difficulty acculturation " (Z60.3)

Patients with the social determinant "near surrounding"

Patients with the selected social determinant of health. Patients with a registered diagnostic "other specific problems related to the nearest surroundings" (Z63.8)

Patients with the social determinant "unemployment"

Patients with the selected social determinant of health. Patients with a registered diagnostic "unemployment not specified" (Z56.0)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Study population: Population assigned and attended at the 32 centers of primary care centers from the Catalan health institute of the Central Catalonia Sanitary Region.

You may qualify if:

  • Phase I:
  • Patients have been attended in their primary care centers during 23 September 2019 to 23 April 2020.
  • The health professionals should complete the study checklist for each patient .
  • Phase II:
  • Patients should sign the informed consent form to enter in a study cohort.

You may not qualify if:

  • Patients with advanced cognitive impairment because they would not be able to complete the study checklist. The study checklist is consist in answering five questions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary healthcare consultations of the Catalan health institute of the central catalonia region

Manresa, Barcelona, 08241, Spain

RECRUITING

Related Publications (1)

  • Rodoreda-Pallas B, Lumillo-Gutierrez I, Miro Catalina Q, Torra Escarrer E, Sanahuja Juncadella J, Morin Fraile V. Recording of Social Determinants in Computerized Medical Records in Primary Care Consultations: Quasi-Experimental Study. JMIR Form Res. 2023 Jan 25;7:e41706. doi: 10.2196/41706.

    PMID: 36696168DERIVED

Study Officials

  • Jacobo Mendioroz peña, MD

    Institut Català de la Salut

    STUDY CHAIR

Central Study Contacts

Berta Rodoreda Pallàs, NR

CONTACT

618625138brodoreda.lleida.ics@gencat.cat

Study Design

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

Study Record Dates

First Submitted

October 31, 2019

First Posted

November 5, 2019

Study Start

September 23, 2019

Primary Completion

May 23, 2021

Study Completion

July 23, 2021

Last Updated

June 23, 2020

Record last verified: 2019-07

Locations

ES(1)