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My Coach Connect: An Automated Telephone-based Reporting System for Patients With Mental Illness (MCC)

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ClinicalTrials.gov Identifier: NCT01749124
Recruitment Status : Unknown
Verified May 2017 by RAND.
Recruitment status was:  Active, not recruiting
First Posted : December 13, 2012
Last Update Posted : May 18, 2017
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
University of California, Los Angeles
Information provided by (Responsible Party):
RAND

Tracking Information
First Submitted Date  ICMJE December 11, 2012
First Posted Date  ICMJE December 13, 2012
Last Update Posted Date May 18, 2017
Study Start Date  ICMJE December 2012
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
Client and provider telephone intervention [ Time Frame: four months ]
Clients will call in to an automated telephone system twice a week and will answer open-ended questions related to how they are doing. In addition, the system will prompt them to complete an automated SF-12 survey every four weeks to assess their mental and physical health status. The content of the voice messages will be made available to the providers as described above. Providers will also be able to indicate using the website whether they found a particular narrative helpful or not. One of the goals of the study is to determine if there is a correlation between the content of the client's messages and their overall health status. To investigate this, we will combine the content of the voice messages with information obtained from the client's medical record including provider observations, assessment, and symptom recording.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
Client and provider survey [ Time Frame: 4 months ]
Each client and provider will be asked to complete a brief survey about their expectations, thoughts and experiences while participating in this study. The survey will be conducted at the time of enrollment as well as the time of disenrollment or completion of the study as a comparison.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 11, 2012)
Discussion groups [ Time Frame: 4 months ]
To better understand the impact of the tool on participants that use it and how to improve the tool, we will also organize discussion groups that clients and providers will have the opportunity to participate in.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE My Coach Connect: An Automated Telephone-based Reporting System for Patients With Mental Illness
Official Title  ICMJE "My Coach Connect": Pilot Under the Partnered Research Center for Quality Care, RHINO 2008-0132
Brief Summary This is a pilot study for a novel, automated telephone system called "My Coach Connect". The purpose of the study is to evaluate the feasibility and effectiveness of this telephone tool while engaging clients and providers in discussion groups and surveys to better understand how this tool impacts the care provided and their overall experience in healthcare.
Detailed Description Clients will use this tool (My Coach Connect) to leave voice messages and survey answers which their providers will have access to by logging in to a secure website. Providers will also be able to indicate using the website whether they found a particular narrative helpful or not. Providers will have access to audio recordings of the voice responses, transcribed text of the responses, as well as "word clouds" generated from the text. Word clouds are a method of displaying the content of text such that words that are used more frequently are displayed in a larger size than words used less frequently. Clients will call in to the system approximately twice a week for a period of four months.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Chronic Mental Illness
  • Major Depression
  • Schizophrenia
  • Bipolar Disorder
Intervention  ICMJE Device: My Coach Connect
Clients will call in to the system approximately twice a week for a period of four months. The study will be conducted in two phases. There will be an initial pilot phase where we will seek to enroll approximately 15-20 patients and 2-3 providers. This phase will last approximately two months and the goal will be to assess feasibility and obtain feedback on the tool and surveys to optimize them for this setting. We will begin the main phase of the study approximately one month after the end of the first phase and in that study seek to recruit approximately 150 patients and 5-10 providers from the ROADS program. Clients enrolled in this main phase of the study will enroll for a period of four months.
Other Name: MCC
Study Arms  ICMJE Experimental: My Coach Connect
To evaluate the feasibility and effectiveness of this telephone tool while engaging clients and providers in discussion groups and surveys to better understand how this tool impacts the care provided and their overall experience in healthcare. Clients will use this tool to leave voice messages and survey answers which their providers will have access to by logging in to a secure website. Providers will have access to audio recordings of the voice responses, transcribed text of the responses, as well as "word clouds" generated from the text. Word clouds are a method of displaying the content of text such that words that are used more frequently are displayed in a larger size than words used less frequently.
Intervention: Device: My Coach Connect
Publications * Not Provided

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 11, 2012)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2017
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Enrolled in the ROADS program
  • English speaking
  • Have a working telephone

Exclusion Criteria:

  • Must speak english
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01749124
Other Study ID Numbers  ICMJE RHINO 2008-0132
P30MH082760 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party RAND
Study Sponsor  ICMJE RAND
Collaborators  ICMJE
  • National Institute of Mental Health (NIMH)
  • University of California, Los Angeles
Investigators  ICMJE
Principal Investigator: Ken Wells, MD, MPH RAND
Principal Investigator: Armen Arevian, MD, PhD University of California, Los Angeles
PRS Account RAND
Verification Date May 2017

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