Opiate DependenceSUBUSQOLNCT02894476
Substance Dependence Satisfaction With Care and Quality Of Life
An observational study of Opiate Dependence and Alcoholism, run by Central Hospital, Nancy, France at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opiate Dependence, Alcoholism, Early Satisfaction With Substance Dependence Care
- How many people
- 600 participants
- Where
- 3 sitesFrance
- Study dates
- Apr 2014to Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients with substance dependence
Who may be able to join
- 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
Who cannot join
- Age lower than 18 years
- Inability to complete self-questionnaires
Trial locations and contacts
3 sites in 1 country.
Stéphanie, BOURION-BEDES, MD-PhD contact
France3 sites, 3 recruiting
- Recruiting
CHS (Hospital of Jury-les-Metz)
Jury-les-Metz, 57073
Olivier POUCLET, 03 87 56 39 60
Olivier POUCLET
- Recruiting
CSAPA (Healthcare Center of Accompaniment and Prevention in Addictology), University Hospital of Nancy
Nancy, 54000
Stéphanie BOURION, MD-PhD, steph_bedes@yahoo.fr
Raymund Schwan, Pr
- Recruiting
ANPAA 15- CSAPA (Healthcare Center of Accompaniment and Prevention in Addictology)
Saint-Flour, 15100
Alex BEDES, 04 71 60 16 85
About this study
Official title: 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.
Read the 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).
- Keywords
- satisfaction with care, outpatient care, self-reported health status, alcohol dependence, opioid dependence
- Medical subject headings
- Opioid-Related Disorders, Alcoholism
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life score
Self-perceived quality of life score using the Short-Form 12 questionnaire (SF-12)
Measured: 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)
Measured: Change from inclusion at 12 months
Secondary outcomes (1)
Care satisfaction
Outpatient satisfaction score using the quality of care satisfaction questionnaire in outpatient consultation (EQS-C)
Measured: 15 and 45 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startApr 2014
- Primary completionMar 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiate DependenceStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital of Jury-les-Metz, France, Healthcare Center of Accompaniment and Prevention in Addictology, Saint-Flour, France
- Responsible party
- Sponsor
- Investigators
- Cédric Baumann, PhD, Principal investigator, CHRU Nancy, PARC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894476
- Sponsor's protocol ID
- SUBUSQOL
- Acronym
- SUBUSQOL
- Status last verified
- Sep 2016
- First submitted
- 26 Aug 2016
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satisfaction With Care and Quality of Life in Subjects With Substance Dependence
- ClinicalTrials.gov ID
- NCT02894476
- Acronym / sponsor ID
- SUBUSQOL / SUBUSQOL
- Keywords
- satisfaction with care, outpatient care, self-reported health status, alcohol dependence, opioid dependence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Hospital of Jury-les-Metz, France, Healthcare Center of Accompaniment and Prevention in Addictology, Saint-Flour, France
- Study start
- Apr 2014
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients with substance dependence
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Age lower than 18 years
- Inability to complete self-questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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)
1 secondary outcome
Care satisfaction
Time frame: 15 and 45 days after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphanie, BOURION-BEDES, MD-PhD contact
Cédric Baumann, PhD principal investigator
CHRU Nancy, PARC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opiate Dependence and Alcoholism, run by Central Hospital, Nancy, France at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stéphanie, BOURION-BEDES, MD-PhD (steph_bedes@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life score (time frame: Change from inclusion at 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2016.