- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02894476
Substance Dependence Satisfaction With Care and Quality Of Life (SUBUSQOL)
September 5, 2016 updated by: Central Hospital, Nancy, France
Satisfaction With Care and Quality of Life in Subjects With Substance Dependence
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.
Study Overview
Status
Unknown
Detailed 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).
Study Type
Observational
Enrollment (Anticipated)
600
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Jury-les-Metz, France, 57073
- Recruiting
- CHS (Hospital of Jury-les-Metz)
-
Contact:
- Olivier POUCLET
- Phone Number: 03 87 56 39 60
-
Sub-Investigator:
- Olivier POUCLET
-
Nancy, France, 54000
- Recruiting
- CSAPA (Healthcare Center of Accompaniment and Prevention in Addictology), University Hospital of Nancy
-
Contact:
- Stéphanie BOURION, MD-PhD
- Email: steph_bedes@yahoo.fr
-
Sub-Investigator:
- Raymund Schwan, Pr
-
Saint-Flour, France, 15100
- Recruiting
- ANPAA 15- CSAPA (Healthcare Center of Accompaniment and Prevention in Addictology)
-
Contact:
- Alex BEDES
- Phone Number: 04 71 60 16 85
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Outpatients with substance dependence
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life score
Time Frame: Change from inclusion at 12 months
|
Self-perceived quality of life score using the Short-Form 12 questionnaire (SF-12)
|
Change from inclusion at 12 months
|
|
Quality of life score
Time Frame: Change from inclusion at 12 months
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Care satisfaction
Time Frame: 15 and 45 days after inclusion
|
Outpatient satisfaction score using the quality of care satisfaction questionnaire in outpatient consultation (EQS-C)
|
15 and 45 days after inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Cédric Baumann, PhD, CHRU Nancy, PARC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Anticipated)
March 1, 2017
Study Completion (Anticipated)
March 1, 2018
Study Registration Dates
First Submitted
August 26, 2016
First Submitted That Met QC Criteria
September 5, 2016
First Posted (Estimate)
September 9, 2016
Study Record Updates
Last Update Posted (Estimate)
September 9, 2016
Last Update Submitted That Met QC Criteria
September 5, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SUBUSQOL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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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