Using Mental Health Telemetry to Predict Relapse and Re-hospitalization in Mood Disorders (PATH-MOD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Sunnybrook Health Sciences Centre
Sponsor:
Collaborator:
Sunnybrook Health Sciences Centre
Information provided by (Responsible Party):
Dr. David Kreindler, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01882608
First received: June 18, 2013
Last updated: November 3, 2013
Last verified: November 2013
  Purpose

Mood disorders -- major depression, bipolar disorder, and dysthymia -- frequently recur; they affect one in four people during their lives. At Sunnybrook, 75% of inpatient admissions are due to mood disorders. Mental health telemetry (MHT) lets patients in the community use cell phones to track the severity of their mood symptoms over time, and enables clinicians to view these symptom ratings in real-time. Evidence suggests that MHT is better for detecting exacerbations of illness earlier than standard clinical practice alone. In this study, we will assess if MHT can reduce re-hospitalization rates in previously-hospitalized patients with mood disorders.


Condition Intervention
Major Depressive Disorder
Bipolar Disorder
Dysthymia
Other: Mental Health Telemetry (MHT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Using Mental Health Telemetry to Predict Relapse and Re-hospitalization in Mood Disorders

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Re-hospitalization rate [ Time Frame: Six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relapse rate [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Rate of recurrence of clinical episode of mood disorders

  • Participation rate [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    Proportion of eligible patients who agree to participate

  • Uptake rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Percent of patients using MHT relative to number of eligible patients

  • Reporting rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Mean number of MHT reports generated per day among MHT users


Estimated Enrollment: 140
Study Start Date: October 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Treatment-as-usual
Treatment-as-usual, with no active intervention or follow-up. TAU patients will have readmission events monitored over the six-month interval by the study RA via periodic chart reviews and updates from their clinicians
Experimental: Mental Health Telemetry (MHT)
Patients in the MHT group will be encouraged to provide daily symptom self-reports using MHT. MHT patients will also have readmission events monitored over the six-month interval by the study RA via periodic chart reviews and updates from their clinicians
Other: Mental Health Telemetry (MHT)
Ecological momentary assessment (EMA) focuses on using data collected from subjects living their daily lives in their natural environments using minimally invasive techniques to improve the quality of the data collected. MHT is an evolution of EMA. MHT was developed at Sunnybrook in partnership with the University of Toronto; it uses cell phones to collect self-report data on symptoms of illness and then transmit it in real-time to a central database. Principal advantages of MHT over EMA include the ability to time- and date-stamp data, thus eliminating retrospective record completion, and the ability to observe and monitor data flow in real-time, without having to wait for participants to upload or deliver the data (e.g., at their next doctors' appointment).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed DSM-IV mood disorder
  • Long-term follow-up at Sunnybrook
  • At least two lifetime hospitalizations for mood disorders at the time of recruitment
  • Own a web-enabled cell phone,
  • Be willing to start or continue with mood journaling using either MHT or some other platform / medium
  • Be able to be successfully trained to use MHT,
  • Have provided informed consent to participate,
  • Have a clinician in the Department of Psychiatry at Sunnybrook who is providing the majority of their mental health care and is participating in this study,
  • In the case of participants under the age of 18 years, have the assent of at least one custodial parent and / or legal guardian

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01882608

Contacts
Contact: Tasmia Hai, B.Sc. 416-528-0396 tasmia.hai@sunnybrook.ca
Contact: David M Kreindler, B.Sc., M.D. 416-480-5225 david.kreindler@sunnybrook.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Principal Investigator: David M Kreindler, B.Sc.,MD         
Sub-Investigator: Anthony J Levitt, MD         
Sponsors and Collaborators
Dr. David Kreindler
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: David M Kreindler, MD Sunnybrook Health Sciences Centre
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. David Kreindler, Staff Physician, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01882608     History of Changes
Other Study ID Numbers: 107-2012
Study First Received: June 18, 2013
Last Updated: November 3, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
psychiatry
mental health
mood disorders
mood diaries
electronic diaries
cell phones
software
mental health telemetry
ecological momentary assessment

Additional relevant MeSH terms:
Bipolar Disorder
Depressive Disorder
Depression
Dysthymic Disorder
Depressive Disorder, Major
Mood Disorders
Affective Disorders, Psychotic
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 23, 2014