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Daily Subjective and Objective Smartphone Measures of Illness Activity to Treat Bipolar Disorder- The MONARCA II Trial (MONARCAII)

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ClinicalTrials.gov Identifier: NCT02221336
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : April 6, 2018
Sponsor:
Collaborators:
University of Copenhagen
IT University of Copenhagen
Information provided by (Responsible Party):
Maria Faurholt-Jepsen, Psychiatric Centre Rigshospitalet

Tracking Information
First Submitted Date  ICMJE August 12, 2014
First Posted Date  ICMJE August 20, 2014
Last Update Posted Date April 6, 2018
Study Start Date  ICMJE September 2014
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2014)
Differences between the groups in depressive and manic symptoms and the number of affective episodes [ Time Frame: Baseline and up to 9 months ]
Differences between the groups in depressive and manic symptoms measured using Hamilton Depression Rating Scale (HDRS) and Young Mania Rating Scale (YMRS) and episodes defined ad HDRS<= 14 and/or YMRS<= 14
Original Primary Outcome Measures  ICMJE
 (submitted: August 18, 2014)
Differences between the groups in depressive and manic symptoms [ Time Frame: Baseline and up to 9 months ]
Differences between the groups in depressive and manic symptoms measured using Hamilton Depression Rating Scale (HDRS) and Young Mania Rating Scale (YMRS)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2014)
  • Differences between the groups in smartphone measures [ Time Frame: Baseline and up to 9 months ]
    Differences between the groups in: -Automatically generated objective smartphone measures
  • Differences between the groups in number of hospitalizations [ Time Frame: Baseline up to 9 months follow up ]
    Differences between the groups in number of hospitalization
  • Differences between the groups in number of contacts to clinicians and emergency rooms [ Time Frame: Baseline up to 9 months follow up ]
    Differences between the groups in number of contacts to clinicians and emergency rooms
  • Differences between the groups in functioning [ Time Frame: Baseline up to 9 months follow up ]
    Differences between the groups in functioning measured using the FAST questionnaire
  • Differences between the groups in perceived stress [ Time Frame: Baseline up to 9 months ]
    Differences between the groups in perceived stress using the perceived stress questionnaire
  • Differences between the groups in quality of life [ Time Frame: Baseline up to 9 months follow up ]
    Differences between the groups in quality of life measured using the WHOQoL questionnaire
  • Differences between the groups in self-rated depressive symptoms [ Time Frame: Baseline up to 9 months ]
    Differences between the groups in self-rated depresisve symptoms using the BDI questionnaire
  • Differences in self-rated manic symptoms [ Time Frame: Baseline up to 9 months follow up ]
    Differences between the groups in self-rated manic symptoms using the ASRM questionnaire
  • Differences between the groups in adherence to medication [ Time Frame: Baseline up to 9 months follow up ]
    Differences between the groups in adherence to medication measured using the questionnaire MARS
  • Differences between the groups in recovery [ Time Frame: Baseline up to 9 months follow up ]
    Differences between the groups in recovery using the questionnaire Recovery Assessment Scale (RAS)
  • Differences between the groups in empowerment [ Time Frame: baseline up ot 9 months ]
    Differences between the groups in empowerment using the questionnaire Rogers Empowerment scale.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2014)
  • Differences between the groups in smartphone measures [ Time Frame: Baseline and up to 9 months ]
    Differences between the groups in: -Automatically generated objective smartphone measures
  • Differences between the groups in number of affective episodes [ Time Frame: Baseline up to 9 months follow up ]
    Differences between the groups in number of affective episodes
  • Differences between the groups in number of hospitalizations [ Time Frame: Baseline up to 9 months follow up ]
    Differences between the groups in number of hospitalization
  • Differences between the groups in number of contacts to clinicians and emergency rooms [ Time Frame: Baseline up to 9 months follow up ]
    Differences between the groups in number of contacts to clinicians and emergency rooms
  • Differences between the groups in functioning [ Time Frame: Baseline up to 9 months follow up ]
    Differences between the groups in functioning measured using the FAST questionnaire
  • Differences between the groups in perceived stress [ Time Frame: Baseline up to 9 months ]
    Differences between the groups in perceived stress using the perceived stress questionnaire
  • Differences between the groups in quality of life [ Time Frame: Baseline up to 9 months follow up ]
    Differences between the groups in quality of life measured using the WHOQoL questionnaire
  • Differences between the groups in self-rated depressive symptoms [ Time Frame: Baseline up to 9 months ]
    Differences between the groups in self-rated depresisve symptoms using the BDI questionnaire
  • Differences in self-rated manic symptoms [ Time Frame: Baseline up to 9 months follow up ]
    Differences between the groups in self-rated manic symptoms using the ASRM questionnaire
  • Differences between the groups in adherence to medication [ Time Frame: Baseline up to 9 months follow up ]
    Differences between the groups in adherence to medication measured using the questionnaire MARS
  • Differences between the groups in recovery [ Time Frame: Baseline up to 9 months follow up ]
    Differences between the groups in recovery using the questionnaire Recovery Assessment Scale (RAS)
  • Differences between the groups in empowerment [ Time Frame: baseline up ot 9 months ]
    Differences between the groups in empowerment using the questionnaire Rogers Empowerment scale.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Daily Subjective and Objective Smartphone Measures of Illness Activity to Treat Bipolar Disorder- The MONARCA II Trial
Official Title  ICMJE Daily Electronic Monitoring of Subjective and Objective Measures of Illness Activity in Bipolar Disorder - The MONARCA II Trial (MONitoring, treAtment and pRediCtion of bipolAr Disorder Episodes II)
Brief Summary

Bipolar disorder is associated with a high risk of relapse and hospitalisation and many patients do not recover to their previous psychosocial function. Major reasons for poor outcomes are delayed intervention for prodromal depressive and manic symptoms as well as decreased adherence with treatment.

Recently, in the MONARCA I trial (NCT01446406), the investigators developed and deployed a smartphone based self-monitoring system (the MONARCA I system) in a randomized controlled trial, to test the effect of daily reporting of subjective self-monitoring of depressive and manic symptoms as well as a bi-directional feedback loop on depressive and manic symptoms.

In the MONARCA II trial the investigators will develop and deploy a new version of the smartphone based monitoring system. The investigators will in a randomized controlled single blind trial investigate whether daily electronic monitoring of subjective and objective measures of illness activity using a smartphone based self-monitoring system including feedback on subjective as well as automatically generated objective data (e.g.social activity, physical activity etc.) (the MONARCA II system) reduces the severity of depressive and manic symptoms and improves functioning more than a control group receiving a smartphone. All patients will be followed for 9 months with outcome assessments at baseline, after 4 weeks, after 3 months, after 6 months and after 9 months.

Detailed Description Not Provided
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 Bipolar Disorder
Intervention  ICMJE
  • Device: The MONARCA II system
    Daily electronic monitoring of subjective and objective smartphone measures including a feedback loop
    Other Name: Non-MONARCA II system (control group condition)
  • Device: Non-MONARCA II system
    Daily use of smartphone for normal communicative purposes. No self-monitoring in the MONARCA II system.
Study Arms  ICMJE
  • Placebo Comparator: Non-MONARCA II system
    Use of smartphone for normal communicative purposes only. No self-monitoring and no feedback loop.
    Intervention: Device: Non-MONARCA II system
  • Experimental: The MONARCA II system
    Daily electronic monitoring of subjective and objective smartphone measures including a feedback loop
    Intervention: Device: The MONARCA II system
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2018)
146
Original Estimated Enrollment  ICMJE
 (submitted: August 18, 2014)
300
Actual Study Completion Date  ICMJE January 2018
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Bipolar Disorder according to SCAN interview
  • ≥18 years of age
  • Patients who previously have received a course of treatment at the Clinic for Affective Disorders, Psychiatric Centre Copenhagen, Denmark

Exclusion Criteria:

  • Pregnancy
  • Lack of Danish language skills
  • Patients who previously have received and used the MONARCA I system for self-monitoring
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 NCT02221336
Other Study ID Numbers  ICMJE H-2-2014-059
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maria Faurholt-Jepsen, Psychiatric Centre Rigshospitalet
Study Sponsor  ICMJE Psychiatric Centre Rigshospitalet
Collaborators  ICMJE
  • University of Copenhagen
  • IT University of Copenhagen
Investigators  ICMJE
Principal Investigator: Maria Faurholt-Jepsen, MD Psychiatric Centre Copenhagen, Rigshospitalet, Denmark
PRS Account Psychiatric Centre Rigshospitalet
Verification Date April 2018

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