The Self Match Study: A Study of Informed Choice in the Treatment of Addiction
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|ClinicalTrials.gov Identifier: NCT03278821|
Recruitment Status : Active, not recruiting
First Posted : September 12, 2017
Last Update Posted : December 11, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Dependence||Behavioral: Self Match Behavioral: Expert Match||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||A Randomized Controlled Study of Patients Matching Themselves to Treatment Options: The Self-Match Study|
|Actual Study Start Date :||May 1, 2017|
|Actual Primary Completion Date :||November 1, 2019|
|Estimated Study Completion Date :||January 29, 2021|
Experimental: Self Match
The patient must choose between the five possible treatment options.
Behavioral: Self Match
Video presentation of treatment option are shown to the patient whereafter the patient must choose between the five possible treatment options.
Active Comparator: Expert Match
The Patient is referred to treatment by standard procedure which is Expert Match based on patient data.
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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03278821
|RESCueH alcohol Studies, Unit of Clinical Alcohol Research, Psyciatric Research Unit, Clinical Institute, University of Southern Denmark|
|Odense, Denmark, DK - 5000 C|