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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 (RADMIS)

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ClinicalTrials.gov Identifier: NCT03033420
Recruitment Status : Active, not recruiting
First Posted : January 26, 2017
Last Update Posted : September 16, 2020
Sponsor:
Collaborator:
Technical University of Denmark
Information provided by (Responsible Party):
Maria Faurholt-Jepsen, Psychiatric Centre Rigshospitalet

Tracking Information
First Submitted Date  ICMJE January 13, 2017
First Posted Date  ICMJE January 26, 2017
Last Update Posted Date September 16, 2020
Actual Study Start Date  ICMJE May 15, 2017
Actual Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
  • Number of re-admissions [ Time Frame: 6 months trial period ]
    Differences in the number of re-admissions between the intervention group and the control group. Data will be collected from Danish registers.
  • Duration of re-admissions [ Time Frame: 6 months trial period ]
    Differences in the duration of re-admissions between the intervention group and the control group.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
  • Severity of depressive symptoms [ Time Frame: 6 months trial period ]
    Differences in the severity of depressive (The Hamilton Depression Rating Scale) symptoms between the intervention group and the control group.
  • Severity of manic symptoms [ Time Frame: 6 months trial period ]
    Differences in the severity of manic (The Young Mania Rating Scale) symptoms between the intervention group and the control group.
  • Psychosocial functioning [ Time Frame: 6 months trial period ]
    Differences in psychosocial functioning (The Psychosocial Functioning Assessment Short Test - FAST) between the intervention group and the control group.
  • Number of affective episodes [ Time Frame: 6 months trial period ]
    Differences in the number of affective episodes between the intervention group and the control group.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 24, 2017)
  • Perceived stress [ Time Frame: 6 months trial period ]
    Differences in perceived stress (The Cohen's Perceived stress scale) between the intervention group and the control group.
  • Quality of life [ Time Frame: 6 months trial period ]
    Differences in quality of life (The WHO Quality of Life-BREF) between the intervention group and the control group.
  • Self-rated manic symptoms [ Time Frame: 6 months trial period ]
    Differences in self-rated manic symptoms (The Altman Self Rating scale for Mania) between the intervention group and the control group.
  • Self-rated depressive symptoms [ Time Frame: 6 months trial period ]
    Differences in self-rated depressive symptoms (The Becks Depressive Inventory) between the intervention group and the control group.
  • Self-rated depressive symptoms [ Time Frame: 6 months trial period ]
    Differences in self-rated depressive symptoms (The Hamilton Depression Self-rating Scale 6-item) between the intervention group and the control group.
  • Recovery [ Time Frame: 6 months trial period ]
    Differences in recovery (The Recovery Assessment Scale) between the intervention group and the control group.
  • Empowerment [ Time Frame: 6 months trial period ]
    Differences in empowerment (Rogers empowerment scale) between the intervention group and the control group.
  • Adherence to medication [ Time Frame: 6 months trial period ]
    Differences in adherence to medication (The Medicine Adherence Rating Scale) between the intervention group and the control group.
  • Well-being [ Time Frame: 6 months trial period ]
    Differences in well-being according (The WHO (five) well-being index) between the intervention group and the control group.
  • Rumination [ Time Frame: 6 months trial period ]
    Differences in rumination (The Rumination Response Scale) between the intervention group and the control group.
  • Worrying [ Time Frame: 6 months trial period ]
    Differences in worrying (The Penn State Worry Questionnaire) between the intervention group and the control group.
  • Satisfaction [ Time Frame: 6 months trial period ]
    Differences in satisfaction (The Verona Satisfaction Scale-Affective Disorder) between the intervention group and the control group.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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 Summary

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).

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Affective Disorders
  • Unipolar Depression
  • Bipolar Disorder
Intervention  ICMJE Device: A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules
A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules
Other Name: Monsenso
Study Arms  ICMJE
  • Experimental: Intervention group
    A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules
    Intervention: Device: A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules
  • No Intervention: Control group
    Treatment-as-usual
Publications * Faurholt-Jepsen M, Frost M, Martiny K, Tuxen N, Rosenberg N, Busk J, Winther O, Bardram JE, Kessing LV. 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: study protocol for two randomized controlled trials. Trials. 2017 Jun 15;18(1):277. doi: 10.1186/s13063-017-2015-3.

*   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: January 24, 2017)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Actual Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Unipolar disorder or bipolar disorder diagnoses according to ICD-10
  • Patients who are discharged from a psychiatric hospital in The Capital Region of Denmark following an affective episode (depression or mania)

Exclusion Criteria:

  • Pregnancy
  • A lack of Danish language skills
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 NCT03033420
Other Study ID Numbers  ICMJE RADMIS
Has Data Monitoring Committee No
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 Maria Faurholt-Jepsen, Psychiatric Centre Rigshospitalet
Study Sponsor  ICMJE Psychiatric Centre Rigshospitalet
Collaborators  ICMJE Technical University of Denmark
Investigators  ICMJE
Principal Investigator: Maria Faurholt-Jepsen, MD Psychiatric Center Copenhagen, Denmark
PRS Account Psychiatric Centre Rigshospitalet
Verification Date September 2020

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