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The Self Match Study: A Study of Informed Choice in the Treatment of Addiction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03278821
Recruitment Status : Active, not recruiting
First Posted : September 12, 2017
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
Kjeld Andersen, University of Southern Denmark

Tracking Information
First Submitted Date  ICMJE March 29, 2017
First Posted Date  ICMJE September 12, 2017
Last Update Posted Date December 11, 2019
Actual Study Start Date  ICMJE May 1, 2017
Actual Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
Reduced amount of drinking days measured by Time Line Follow Back. [ Time Frame: 6 months after initiation of treatment. ]
The primary endpoint analysis will be a comparison of outcomes for patients assigned to the self-match group vs. expert-match group to determine whether self-matching yields more favorable outcome than expert matching, measured by the number of excessive drinking days.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
  • Compliance measured by proportion of patients who has completed treatment. [ Time Frame: 6 months after treatment start ]
    Data on patients who have completed treatment as planned will be gathered from treatment journal.
  • Quality of life measured by WHO's Quality of Life scale. [ Time Frame: 6 months after treatment start. ]
    Patients reporting increase or decrease in quality of life compared to baseline.
  • Personality traits, measured by NEO-FFI-3, influence on outcome. [ Time Frame: 6 months after treatment start. ]
    Comparison of personality traits with outcome measures.
  • Deviation in the chosen treatment in the Self-Match group in relation to the expected expert choice. [ Time Frame: 6 months after treatment start. ]
    The algorithm score used in expert-matching will be calculated for all patients. The chosen treatment for patients in The Self-Match Group will be compared to the algorithm score to measure convergence between Self-Match and Expert-Match.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Self Match Study: A Study of Informed Choice in the Treatment of Addiction
Official Title  ICMJE A Randomized Controlled Study of Patients Matching Themselves to Treatment Options: The Self-Match Study
Brief Summary

The purpose of this study is to determine whether patient self-matching (as compared with treatment as usual by expert matching) improves quality of life, retention, and outcome for patients being treated for alcohol problems.

There are at least two good reasons for offering patients a choice when the goal is a change in their behavior. The first is that patients are likely to know what treatment works best for them. Secondly, being allowed to choose between options may increase compliance in treatment. As a randomized controlled trial, this study will compare the efficacy of patient self-matching versus treatment-as-usual expert matching.

The Self-Match Study is expected to increase knowledge on the importance of involving the alcohol dependent patient in choosing what treatment method is best for him/her instead of having experts to do that. The investigators expect to discover patient involvement as a way to improve compliance in treatment, hence preventing that patients drop out of treatment to early. If this hypothesis proves to be right, clinicians will have a viable strategy for matching treatment methods to patients, since the strategy does not demand further resources in the treatment system.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Alcohol Dependence
Intervention  ICMJE
  • Behavioral: Self Match
    Video presentation of treatment option are shown to the patient whereafter the patient must choose between the five possible treatment options.
  • Behavioral: Expert Match
    Referral as usual to one of five possible treatment options. The referral is based on baseline data from the patient and by the means of an algorithm, used in daily clinical praxis.
Study Arms  ICMJE
  • Experimental: Self Match
    The patient must choose between the five possible treatment options.
    Intervention: Behavioral: Self Match
  • Active Comparator: Expert Match
    The Patient is referred to treatment by standard procedure which is Expert Match based on patient data.
    Intervention: Behavioral: Expert Match
Publications * Hell ME, Miller WR, Nielsen B, Nielsen AS. Is treatment outcome improved if patients match themselves to treatment options? Study protocol for a randomized controlled trial. Trials. 2018 Apr 6;19(1):219. doi: 10.1186/s13063-018-2592-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 8, 2017)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 29, 2021
Actual Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Fulfilling DSM-IV criteria for alcohol abuse or dependence.
  2. Native Danish speaking.
  3. Having no severe psychosis or cognitive impairment.
  4. Accepting to participate in the study.

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03278821
Other Study ID Numbers  ICMJE RESCueH, The Self Match Study
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kjeld Andersen, University of Southern Denmark
Study Sponsor  ICMJE Kjeld Andersen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Southern Denmark
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP