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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02894476
Other study ID # SUBUSQOL
Secondary ID
Status Recruiting
Phase N/A
First received August 26, 2016
Last updated September 5, 2016
Start date April 2014
Est. completion date March 2018

Study information

Verified date September 2016
Source Central Hospital, Nancy, France
Contact Stéphanie , BOURION-BEDES, MD-PhD
Email steph_bedes@yahoo.fr
Is FDA regulated No
Health authority France: Commission nationale de l'informatique et des libertés
Study type Observational

Clinical Trial Summary

The SUBUSQOL cohort aimed to improve knowledge of the quality of ambulatory care, in particular the prognostic role of the early satisfaction with care on the change from baseline quality of self-reported health status in outpatients with alcohol or opioid dependence. It is a multicenter prospective cohort. Satisfaction was assessed using a multidimensional self-administered and validated questionnaire during the early care process. In addition to measuring satisfaction and obtaining sociodemographic and clinical data, this study collected data on the self-reported health status at inclusion and 3, 6 and 12 months after inclusion.


Description:

Early satisfaction with care was measured using the quality of care satisfaction questionnaire in outpatient consultation (EQS-C). Data collected during the study included patient sociodemographic, clinical and health status characteristics, as well as physician characteristics. Self-perceived quality of life was assessed using the generic SF-12 and a specific questionnaire in illness disease, the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF).


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date March 2018
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Outpatients who met the Diagnostic and Statistical Manual, fourth edition (DSM-IV) criteria for alcohol dependence, opioid dependence, or both.

- Patients recruited from the French specialized addiction treatment centers where they began care.

- Patient agreement obtained

Exclusion Criteria:

- Age lower than 18 years

- Inability to complete self-questionnaires

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
France CHS (Hospital of Jury-les-Metz) Jury-les-Metz
France CSAPA (Healthcare Center of Accompaniment and Prevention in Addictology), University Hospital of Nancy Nancy
France ANPAA 15- CSAPA (Healthcare Center of Accompaniment and Prevention in Addictology) Saint-Flour

Sponsors (3)

Lead Sponsor Collaborator
Central Hospital, Nancy, France Healthcare Center of Accompaniment and Prevention in Addictology, Saint-Flour, France, Hospital of Jury-les-Metz, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of life score Self-perceived quality of life score using the Short-Form 12 questionnaire (SF-12) Change from inclusion at 12 months No
Primary Quality of life score Self-perceived quality of life score using the Quality of life enjoyment and satisfaction questionnaire short form (Q-LES-Q-SF) Change from inclusion at 12 months No
Secondary Care satisfaction Outpatient satisfaction score using the quality of care satisfaction questionnaire in outpatient consultation (EQS-C) 15 and 45 days after inclusion No
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