<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/NCT03033420</url>
  </required_header>
  <id_info>
    <org_study_id>RADMIS</org_study_id>
    <nct_id>NCT03033420</nct_id>
  </id_info>
  <brief_title>Reducing the Rate and Duration of Re-ADMISsions Among Patients With Unipolar Disorder and Bipolar Disorder Using Smartphone-based Monitoring and Treatment - The RADMIS Trials</brief_title>
  <acronym>RADMIS</acronym>
  <official_title>Reducing the Rate and Duration of Re-ADMISsions Among Patients With Unipolar Disorder and Bipolar Disorder Using Smartphone-based Monitoring and Treatment - The RADMIS Trials</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Psychiatric Centre Rigshospitalet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Technical University of Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Psychiatric Centre Rigshospitalet</source>
  <oversight_info>
    <has_dmc>No</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>
      Unipolar and bipolar disorder combined account for nearly half of all morbidity and mortality&#xD;
      due to mental and substance use disorders, and burden society with the highest health care&#xD;
      costs of all psychiatric and neurological disorders. Among these, costs due to psychiatric&#xD;
      hospitalization is a major burden. Smartphones comprise an innovative and unique platform for&#xD;
      monitoring and treatment of depression and mania.&#xD;
&#xD;
      The RADMIS trials use a randomized controlled single-blind parallel-group design. Patients&#xD;
      with unipolar or bipolar disorder discharged from psychiatric hospitals in The Capital Region&#xD;
      of Denmark are invited to participate. Patients are at discharge from the psychiatric&#xD;
      hospitals randomized, separately according to psychiatric diagnosis (thus, the RADMIS trial&#xD;
      consists of two separate trials according to diagnosis, bipolar disorder or unipolar&#xD;
      disorder), to: 1) a smartphone-based monitoring system including a) an integrated feedback&#xD;
      loop between patients and clinicians and b) context-aware CBT modules (intervention group) or&#xD;
      2) treatment-as-usual (control group) for a 6-months trial period. The trial is started in&#xD;
      March 2017. The outcomes are 1) differences in the number and duration of re-admissions&#xD;
      between the intervention group and the control group (primary), 2) differences in severity of&#xD;
      depressive and manic symptoms (manic symptoms only for patients with bipolar disorder);&#xD;
      differences in psychosocial functioning; and differences in number of affective episodes&#xD;
      between the intervention group and the control group (secondary), and 3) differences in&#xD;
      perceived stress, quality of life, self-rated depressive symptoms, self-rated manic symptoms&#xD;
      (only for patients with bipolar disorder), recovery, empowerment, adherence to medication,&#xD;
      well-being, ruminations, worrying, and satisfaction between the intervention group and the&#xD;
      control group (tertiary).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background Unipolar and bipolar disorder combined account for nearly half of all morbidity&#xD;
      and mortality due to mental and substance use disorders, and burden society with the highest&#xD;
      health care costs of all psychiatric and neurological disorders. Among these, costs due to&#xD;
      psychiatric hospitalization are a major burden. Smartphones comprise an innovative and unique&#xD;
      platform for monitoring and treatment of depression and mania. No prior trial has&#xD;
      investigated whether the use of a smartphone-based system can prevent re-admission among&#xD;
      patients discharged from hospital.&#xD;
&#xD;
      Methods The RADMIS trials use a randomized controlled single-blind parallel-group design.&#xD;
      Patients with unipolar disorder and patients with bipolar disorder are invited to participate&#xD;
      in each their trial when discharged from psychiatric hospitals in The Capital Region of&#xD;
      Denmark following an affective episode and randomized to either 1) a smartphone-based&#xD;
      monitoring system including a) an integrated feedback loop between patients and clinicians&#xD;
      and b) context-aware CBT modules (intervention group) or 2) standard treatment (control&#xD;
      group) for a 6-months trial period. The trial is started in March 2017. The outcomes are 1)&#xD;
      differences in the number and duration of re-admissions between the intervention group and&#xD;
      the control group (primary), 2) differences in severity of depressive and manic symptoms&#xD;
      (manic symptoms only for patients with bipolar disorder); differences in psychosocial&#xD;
      functioning; and differences in number of affective episodes between the intervention group&#xD;
      and the control group (secondary), and 3) differences in perceived stress, quality of life,&#xD;
      self-rated depressive symptoms, self-rated manic symptoms (only for patients with bipolar&#xD;
      disorder), recovery, empowerment, adherence to medication, well-being, ruminations, worrying,&#xD;
      and satisfaction between the intervention group and the control group (tertiary).&#xD;
&#xD;
      Analysis Recruitment is ongoing.&#xD;
&#xD;
      Discussion If the smartphone-based monitoring system is proved effective in reducing the rate&#xD;
      and duration of re-admissions there will be basis for using a system of this kind in the&#xD;
      treatment of unipolar and bipolar disorder in general and in a larger scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2017</start_date>
  <completion_date type="Actual">May 1, 2021</completion_date>
  <primary_completion_date type="Actual">March 1, 2020</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of re-admissions</measure>
    <time_frame>6 months trial period</time_frame>
    <description>Differences in the number of re-admissions between the intervention group and the control group. Data will be collected from Danish registers.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of re-admissions</measure>
    <time_frame>6 months trial period</time_frame>
    <description>Differences in the duration of re-admissions between the intervention group and the control group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Severity of depressive symptoms</measure>
    <time_frame>6 months trial period</time_frame>
    <description>Differences in the severity of depressive (The Hamilton Depression Rating Scale) symptoms between the intervention group and the control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of manic symptoms</measure>
    <time_frame>6 months trial period</time_frame>
    <description>Differences in the severity of manic (The Young Mania Rating Scale) symptoms between the intervention group and the control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial functioning</measure>
    <time_frame>6 months trial period</time_frame>
    <description>Differences in psychosocial functioning (The Psychosocial Functioning Assessment Short Test - FAST) between the intervention group and the control group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of affective episodes</measure>
    <time_frame>6 months trial period</time_frame>
    <description>Differences in the number of affective episodes between the intervention group and the control group.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Perceived stress</measure>
    <time_frame>6 months trial period</time_frame>
    <description>Differences in perceived stress (The Cohen's Perceived stress scale) between the intervention group and the control group.</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of life</measure>
    <time_frame>6 months trial period</time_frame>
    <description>Differences in quality of life (The WHO Quality of Life-BREF) between the intervention group and the control group.</description>
  </other_outcome>
  <other_outcome>
    <measure>Self-rated manic symptoms</measure>
    <time_frame>6 months trial period</time_frame>
    <description>Differences in self-rated manic symptoms (The Altman Self Rating scale for Mania) between the intervention group and the control group.</description>
  </other_outcome>
  <other_outcome>
    <measure>Self-rated depressive symptoms</measure>
    <time_frame>6 months trial period</time_frame>
    <description>Differences in self-rated depressive symptoms (The Becks Depressive Inventory) between the intervention group and the control group.</description>
  </other_outcome>
  <other_outcome>
    <measure>Self-rated depressive symptoms</measure>
    <time_frame>6 months trial period</time_frame>
    <description>Differences in self-rated depressive symptoms (The Hamilton Depression Self-rating Scale 6-item) between the intervention group and the control group.</description>
  </other_outcome>
  <other_outcome>
    <measure>Recovery</measure>
    <time_frame>6 months trial period</time_frame>
    <description>Differences in recovery (The Recovery Assessment Scale) between the intervention group and the control group.</description>
  </other_outcome>
  <other_outcome>
    <measure>Empowerment</measure>
    <time_frame>6 months trial period</time_frame>
    <description>Differences in empowerment (Rogers empowerment scale) between the intervention group and the control group.</description>
  </other_outcome>
  <other_outcome>
    <measure>Adherence to medication</measure>
    <time_frame>6 months trial period</time_frame>
    <description>Differences in adherence to medication (The Medicine Adherence Rating Scale) between the intervention group and the control group.</description>
  </other_outcome>
  <other_outcome>
    <measure>Well-being</measure>
    <time_frame>6 months trial period</time_frame>
    <description>Differences in well-being according (The WHO (five) well-being index) between the intervention group and the control group.</description>
  </other_outcome>
  <other_outcome>
    <measure>Rumination</measure>
    <time_frame>6 months trial period</time_frame>
    <description>Differences in rumination (The Rumination Response Scale) between the intervention group and the control group.</description>
  </other_outcome>
  <other_outcome>
    <measure>Worrying</measure>
    <time_frame>6 months trial period</time_frame>
    <description>Differences in worrying (The Penn State Worry Questionnaire) between the intervention group and the control group.</description>
  </other_outcome>
  <other_outcome>
    <measure>Satisfaction</measure>
    <time_frame>6 months trial period</time_frame>
    <description>Differences in satisfaction (The Verona Satisfaction Scale-Affective Disorder) between the intervention group and the control group.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Affective Disorders</condition>
  <condition>Unipolar Depression</condition>
  <condition>Bipolar Disorder</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Treatment-as-usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules</intervention_name>
    <description>A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules</description>
    <arm_group_label>Intervention group</arm_group_label>
    <other_name>Monsenso</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unipolar disorder or bipolar disorder diagnoses according to ICD-10&#xD;
&#xD;
          -  Patients who are discharged from a psychiatric hospital in The Capital Region of&#xD;
             Denmark following an affective episode (depression or mania)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  A lack of Danish language skills&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Faurholt-Jepsen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Psychiatric Center Copenhagen, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Psychiatric Center Copenhagen, Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>September 28, 2022</last_update_submitted>
  <last_update_submitted_qc>September 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Psychiatric Centre Rigshospitalet</investigator_affiliation>
    <investigator_full_name>Maria Faurholt-Jepsen</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>Unipolar disorder</keyword>
  <keyword>Bipolar disorder</keyword>
  <keyword>Randomized controlled trial</keyword>
  <keyword>Smartphone</keyword>
  <keyword>Re-admission</keyword>
  <keyword>CBT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bipolar Disorder</mesh_term>
    <mesh_term>Mood Disorders</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03033420
org study id: RADMIS
nct id: NCT03033420
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Unipolar and bipolar disorder combined account for nearly half of all morbidity and mortality
      due to mental and substance use disorders, and burden society with the highest health care
      costs of all psychiatric and neurological disorders. Among these, costs due to psychiatric
      hospitalization is a major burden. Smartphones comprise an innovative and unique platform for
      monitoring and treatment of depression and mania.

      The RADMIS trials use a randomized controlled single-blind parallel-group design. Patients
      with unipolar or bipolar disorder discharged from psychiatric hospitals in The Capital Region
      of Denmark are invited to participate. Patients are at discharge from the psychiatric
      hospitals randomized, separately according to psychiatric diagnosis (thus, the RADMIS trial
      consists of two separate trials according to diagnosis, bipolar disorder or unipolar
      disorder), to: 1) a smartphone-based monitoring system including a) an integrated feedback
      loop between patients and clinicians and b) context-aware CBT modules (intervention group) or
      2) treatment-as-usual (control group) for a 6-months trial period. The trial is started in
      March 2017. The outcomes are 1) differences in the number and duration of re-admissions
      between the intervention group and the control group (primary), 2) differences in severity of
      depressive and manic symptoms (manic symptoms only for patients with bipolar disorder);
      differences in psychosocial functioning; and differences in number of affective episodes
      between the intervention group and the control group (secondary), and 3) differences in
      perceived stress, quality of life, self-rated depressive symptoms, self-rated manic symptoms
      (only for patients with bipolar disorder), recovery, empowerment, adherence to medication,
      well-being, ruminations, worrying, and satisfaction between the intervention group and the
      control group (tertiary).
Background Unipolar and bipolar disorder combined account for nearly half of all morbidity
      and mortality due to mental and substance use disorders, and burden society with the highest
      health care costs of all psychiatric and neurological disorders. Among these, costs due to
      psychiatric hospitalization are a major burden. Smartphones comprise an innovative and unique
      platform for monitoring and treatment of depression and mania. No prior trial has
      investigated whether the use of a smartphone-based system can prevent re-admission among
      patients discharged from hospital.

      Methods The RADMIS trials use a randomized controlled single-blind parallel-group design.
      Patients with unipolar disorder and patients with bipolar disorder are invited to participate
      in each their trial when discharged from psychiatric hospitals in The Capital Region of
      Denmark following an affective episode and randomized to either 1) a smartphone-based
      monitoring system including a) an integrated feedback loop between patients and clinicians
      and b) context-aware CBT modules (intervention group) or 2) standard treatment (control
      group) for a 6-months trial period. The trial is started in March 2017. The outcomes are 1)
      differences in the number and duration of re-admissions between the intervention group and
      the control group (primary), 2) differences in severity of depressive and manic symptoms
      (manic symptoms only for patients with bipolar disorder); differences in psychosocial
      functioning; and differences in number of affective episodes between the intervention group
      and the control group (secondary), and 3) differences in perceived stress, quality of life,
      self-rated depressive symptoms, self-rated manic symptoms (only for patients with bipolar
      disorder), recovery, empowerment, adherence to medication, well-being, ruminations, worrying,
      and satisfaction between the intervention group and the control group (tertiary).

      Analysis Recruitment is ongoing.

      Discussion If the smartphone-based monitoring system is proved effective in reducing the rate
      and duration of re-admissions there will be basis for using a system of this kind in the
      treatment of unipolar and bipolar disorder in general and in a larger scale.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Number of re-admissions
time frame: 6 months trial period
description: Differences in the number of re-admissions between the intervention group and the control group. Data will be collected from Danish registers.
measure: Duration of re-admissions
time frame: 6 months trial period
description: Differences in the duration of re-admissions between the intervention group and the control group.
measure: Severity of depressive symptoms
time frame: 6 months trial period
description: Differences in the severity of depressive (The Hamilton Depression Rating Scale) symptoms between the intervention group and the control group.
measure: Severity of manic symptoms
time frame: 6 months trial period
description: Differences in the severity of manic (The Young Mania Rating Scale) symptoms between the intervention group and the control group.
measure: Psychosocial functioning
time frame: 6 months trial period
description: Differences in psychosocial functioning (The Psychosocial Functioning Assessment Short Test - FAST) between the intervention group and the control group.
measure: Number of affective episodes
time frame: 6 months trial period
description: Differences in the number of affective episodes between the intervention group and the control group.
measure: Perceived stress
time frame: 6 months trial period
description: Differences in perceived stress (The Cohen's Perceived stress scale) between the intervention group and the control group.
measure: Quality of life
time frame: 6 months trial period
description: Differences in quality of life (The WHO Quality of Life-BREF) between the intervention group and the control group.
measure: Self-rated manic symptoms
time frame: 6 months trial period
description: Differences in self-rated manic symptoms (The Altman Self Rating scale for Mania) between the intervention group and the control group.
measure: Self-rated depressive symptoms
time frame: 6 months trial period
description: Differences in self-rated depressive symptoms (The Becks Depressive Inventory) between the intervention group and the control group.
measure: Self-rated depressive symptoms
time frame: 6 months trial period
description: Differences in self-rated depressive symptoms (The Hamilton Depression Self-rating Scale 6-item) between the intervention group and the control group.
measure: Recovery
time frame: 6 months trial period
description: Differences in recovery (The Recovery Assessment Scale) between the intervention group and the control group.
measure: Empowerment
time frame: 6 months trial period
description: Differences in empowerment (Rogers empowerment scale) between the intervention group and the control group.
measure: Adherence to medication
time frame: 6 months trial period
description: Differences in adherence to medication (The Medicine Adherence Rating Scale) between the intervention group and the control group.
measure: Well-being
time frame: 6 months trial period
description: Differences in well-being according (The WHO (five) well-being index) between the intervention group and the control group.
measure: Rumination
time frame: 6 months trial period
description: Differences in rumination (The Rumination Response Scale) between the intervention group and the control group.
measure: Worrying
time frame: 6 months trial period
description: Differences in worrying (The Penn State Worry Questionnaire) between the intervention group and the control group.
measure: Satisfaction
time frame: 6 months trial period
description: Differences in satisfaction (The Verona Satisfaction Scale-Affective Disorder) between the intervention group and the control group.
arm group label: Intervention group
arm group type: Experimental
description: A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules
arm group label: Control group
arm group type: No Intervention
description: Treatment-as-usual
intervention type: Device
intervention name: A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules
description: A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules
arm group label: Intervention group
other name: Monsenso
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maria Faurholt-Jepsen, MD
role: Principal Investigator
affiliation: Psychiatric Center Copenhagen, Denmark
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Psychiatric Centre Rigshospitalet
investigator full name: Maria Faurholt-Jepsen
investigator title: Medical Doctor
mesh term: Bipolar Disorder
mesh term: Mood Disorders
mesh term: Depressive Disorder
sharing ipd: No