- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04151056
Impact of the Social Determinants of Health in the Central Catalan Region
Study Overview
Status
Conditions
Detailed Description
Currently, the social problems are hidden behind clinical diagnostics. This may lead to overdiagnosis and overtreatment of some discomforts/pathologies that are observed in primary care centers that may respond better to community level interventions and promotion of health actions.
It is longitudinal , multicentered, pre and post intervention study, conducted by health professionals of central Catalonia sanitary region during 2019 Prior to the intervention, the number and type of social coded diagnoses in the clinical history is going to be described. Subsequently, an intervention will be carried out: training the professionals in the homogeneous codification of five selected social determinants. This codification will be systematically applied .The number and type of social diagnostics registered in the pre and post-intervention periods is going to be compared. Finally, the impact analysis of the social determinants is going to be carried out.
Afterwards the investigators plan to search solutions at Community level for the select social diagnoses
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Barcelona
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Manresa, Barcelona, Spain, 08241
- Recruiting
- Primary healthcare consultations of the Catalan health institute of the central catalonia region
-
Contact:
- Jacobo Mendioroz Peña, MD
- Email: jmendioroz.cc.ics@gencat.cat
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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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)
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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)
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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)
|
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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)
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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)
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Patients with the social determinant "unemployment"
Patients with the selected social determinant of health.
Patients with a registered diagnostic "unemployment not specified" (Z56.0)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Population Taxes
Time Frame: 12 month
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In the descriptive basal analysis, the population taxes of all social diagnoses is going to be described.
|
12 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sociodemographic subcategories
Time Frame: 7 month
|
The sociodemographic data described in the study are:
|
7 month
|
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Comparison with the post-intervention data of the six diagnostics with Chi Quadrat Test.
Time Frame: 7 month
|
For this comparison is going to be used independent samples in the different subcategories. The 6 diagnostics used are:
|
7 month
|
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Social Impact. Parametric and non parametric test
Time Frame: 12 month
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It will be evaluated health differences in the six coded groups (including the control group) through appropriate parametric and non-parametric tests , It is going to be compared the average of each selected dependent health variables in social coded diagnoses and the screened patients group without a social diagnosis The dependent health variables are going to be analysed after the codification of the six selected diagnosis. The study dependent health variables are:
|
12 month
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Jacobo Mendioroz peña, MD, Institut Català de la Salut
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 19/079-P
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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