<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03278821</url>
  </required_header>
  <id_info>
    <org_study_id>RESCueH, The Self Match Study</org_study_id>
    <nct_id>NCT03278821</nct_id>
  </id_info>
  <brief_title>The Self Match Study: A Study of Informed Choice in the Treatment of Addiction</brief_title>
  <official_title>A Randomized Controlled Study of Patients Matching Themselves to Treatment Options: The Self-Match Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kjeld Andersen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Southern Denmark</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether patient self-matching (as compared with&#xD;
      treatment as usual by expert matching) improves quality of life, retention, and outcome for&#xD;
      patients being treated for alcohol problems.&#xD;
&#xD;
      There are at least two good reasons for offering patients a choice when the goal is a change&#xD;
      in their behavior. The first is that patients are likely to know what treatment works best&#xD;
      for them. Secondly, being allowed to choose between options may increase compliance in&#xD;
      treatment. As a randomized controlled trial, this study will compare the efficacy of patient&#xD;
      self-matching versus treatment-as-usual expert matching.&#xD;
&#xD;
      The Self-Match Study is expected to increase knowledge on the importance of involving the&#xD;
      alcohol dependent patient in choosing what treatment method is best for him/her instead of&#xD;
      having experts to do that. The investigators expect to discover patient involvement as a way&#xD;
      to improve compliance in treatment, hence preventing that patients drop out of treatment to&#xD;
      early. If this hypothesis proves to be right, clinicians will have a viable strategy for&#xD;
      matching treatment methods to patients, since the strategy does not demand further resources&#xD;
      in the treatment system.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">January 29, 2021</completion_date>
  <primary_completion_date type="Actual">November 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduced amount of drinking days measured by Time Line Follow Back.</measure>
    <time_frame>6 months after initiation of treatment.</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compliance measured by proportion of patients who has completed treatment.</measure>
    <time_frame>6 months after treatment start</time_frame>
    <description>Data on patients who have completed treatment as planned will be gathered from treatment journal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life measured by WHO's Quality of Life scale.</measure>
    <time_frame>6 months after treatment start.</time_frame>
    <description>Patients reporting increase or decrease in quality of life compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Personality traits, measured by NEO-FFI-3, influence on outcome.</measure>
    <time_frame>6 months after treatment start.</time_frame>
    <description>Comparison of personality traits with outcome measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Deviation in the chosen treatment in the Self-Match group in relation to the expected expert choice.</measure>
    <time_frame>6 months after treatment start.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">400</enrollment>
  <condition>Alcohol Dependence</condition>
  <arm_group>
    <arm_group_label>Self Match</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patient must choose between the five possible treatment options.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expert Match</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Patient is referred to treatment by standard procedure which is Expert Match based on patient data.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self Match</intervention_name>
    <description>Video presentation of treatment option are shown to the patient whereafter the patient must choose between the five possible treatment options.</description>
    <arm_group_label>Self Match</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Expert Match</intervention_name>
    <description>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.</description>
    <arm_group_label>Expert Match</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Fulfilling DSM-IV criteria for alcohol abuse or dependence.&#xD;
&#xD;
          2. Native Danish speaking.&#xD;
&#xD;
          3. Having no severe psychosis or cognitive impairment.&#xD;
&#xD;
          4. Accepting to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>RESCueH alcohol Studies, Unit of Clinical Alcohol Research, Psyciatric Research Unit, Clinical Institute, University of Southern Denmark</name>
      <address>
        <city>Odense</city>
        <zip>DK - 5000 C</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>March 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>October 26, 2021</last_update_submitted>
  <last_update_submitted_qc>October 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern Denmark</investigator_affiliation>
    <investigator_full_name>Kjeld Andersen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Informed choice</keyword>
  <keyword>Alcohol use disorder</keyword>
  <keyword>Addiction treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 4, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT03278821/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03278821
org study id: RESCueH, The Self Match Study
nct id: NCT03278821
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Care Provider)
measure: Reduced amount of drinking days measured by Time Line Follow Back.
time frame: 6 months after initiation of treatment.
description: 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.
measure: Compliance measured by proportion of patients who has completed treatment.
time frame: 6 months after treatment start
description: Data on patients who have completed treatment as planned will be gathered from treatment journal.
measure: Quality of life measured by WHO's Quality of Life scale.
time frame: 6 months after treatment start.
description: Patients reporting increase or decrease in quality of life compared to baseline.
measure: Personality traits, measured by NEO-FFI-3, influence on outcome.
time frame: 6 months after treatment start.
description: Comparison of personality traits with outcome measures.
measure: Deviation in the chosen treatment in the Self-Match group in relation to the expected expert choice.
time frame: 6 months after treatment start.
description: 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.
arm group label: Self Match
arm group type: Experimental
description: The patient must choose between the five possible treatment options.
arm group label: Expert Match
arm group type: Active Comparator
description: The Patient is referred to treatment by standard procedure which is Expert Match based on patient data.
intervention type: Behavioral
intervention name: Self Match
description: Video presentation of treatment option are shown to the patient whereafter the patient must choose between the five possible treatment options.
arm group label: Self Match
intervention type: Behavioral
intervention name: Expert Match
description: 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.
arm group label: Expert Match
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: University of Southern Denmark
investigator full name: Kjeld Andersen
investigator title: Professor
mesh term: Alcoholism
sharing ipd: No
provided document: 