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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 : Recruiting
First Posted : January 26, 2017
Last Update Posted : August 29, 2018
Sponsor:
Collaborator:
Technical University of Denmark
Information provided by (Responsible Party):
Maria Faurholt-Jepsen, Psychiatric Centre Rigshospitalet

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).


Condition or disease Intervention/treatment Phase
Affective Disorders Unipolar Depression Bipolar Disorder Device: A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Experimental: Intervention group
A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules
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

No Intervention: Control group
Treatment-as-usual



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Recovery [ Time Frame: 6 months trial period ]
    Differences in recovery (The Recovery Assessment Scale) between the intervention group and the control group.

  7. Empowerment [ Time Frame: 6 months trial period ]
    Differences in empowerment (Rogers empowerment scale) between the intervention group and the control group.

  8. 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.

  9. 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.

  10. Rumination [ Time Frame: 6 months trial period ]
    Differences in rumination (The Rumination Response Scale) between the intervention group and the control group.

  11. Worrying [ Time Frame: 6 months trial period ]
    Differences in worrying (The Penn State Worry Questionnaire) between the intervention group and the control group.

  12. Satisfaction [ Time Frame: 6 months trial period ]
    Differences in satisfaction (The Verona Satisfaction Scale-Affective Disorder) between the intervention group and the control group.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT03033420


Contacts
Contact: Maria Faurholt-Jepsen, MD +45 38647073 maria.faurholtjepsen@regionh.dk
Contact: Lars V Kessing, Prof,DMSc,MD +45 38647073 lars.vedel.kessing@regionh.dk

Locations
Denmark
Psychiatric Center Copenhagen, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Maria Faurholt-Jepsen, MD    +45 38647073    maria.faurholtjepsen@regionh.dk   
Sponsors and Collaborators
Psychiatric Centre Rigshospitalet
Technical University of Denmark
Investigators
Principal Investigator: Maria Faurholt-Jepsen, MD Psychiatric Center Copenhagen, Denmark

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maria Faurholt-Jepsen, Medical Doctor, Psychiatric Centre Rigshospitalet
ClinicalTrials.gov Identifier: NCT03033420     History of Changes
Other Study ID Numbers: RADMIS
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maria Faurholt-Jepsen, Psychiatric Centre Rigshospitalet:
Unipolar disorder
Bipolar disorder
Randomized controlled trial
Smartphone
Re-admission
CBT

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Mood Disorders
Depressive Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders