NCT02894476

Brief 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.

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
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

September 9, 2016

Status Verified

September 1, 2016

Enrollment Period

2.9 years

First QC Date

August 26, 2016

Last Update Submit

September 5, 2016

Conditions

Keywords

satisfaction with careoutpatient careself-reported health statusalcohol dependenceopioid dependence

Outcome Measures

Primary Outcomes (2)

  • Quality of life score

    Self-perceived quality of life score using the Short-Form 12 questionnaire (SF-12)

    Change from inclusion at 12 months

  • 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

Secondary Outcomes (1)

  • Care satisfaction

    15 and 45 days after inclusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatients with substance dependence

You may qualify if:

  • 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

You may not qualify if:

  • Age lower than 18 years
  • Inability to complete self-questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHS (Hospital of Jury-les-Metz)

Jury-les-Metz, 57073, France

RECRUITING

CSAPA (Healthcare Center of Accompaniment and Prevention in Addictology), University Hospital of Nancy

Nancy, 54000, France

RECRUITING

ANPAA 15- CSAPA (Healthcare Center of Accompaniment and Prevention in Addictology)

Saint-Flour, 15100, France

RECRUITING

MeSH Terms

Conditions

Opioid-Related DisordersAlcoholism

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersAlcohol-Related Disorders

Study Officials

  • Cédric Baumann, PhD

    CHRU Nancy, PARC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphanie, BOURION-BEDES, MD-PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

August 26, 2016

First Posted

September 9, 2016

Study Start

April 1, 2014

Primary Completion

March 1, 2017

Study Completion

March 1, 2018

Last Updated

September 9, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations