- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01473550
Mental Health Engagement Network (MHEN) (MHEN)
March 4, 2016 updated by: Cheryl Forchuk, Lawson Health Research Institute
Mental Health Engagement Network (MHEN): Connecting Clients With Their Health Team
Patients with mood disorder or psychotic disorder will be given handheld devices with personal health records to educate, monitor and deliver customizable healthcare tools based on their personal needs.
The use of technology has great potential to deliver care more effectively and efficiently.
No actual information is on the handheld device - it is accessed from a secure site behind hospital firewalls.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
400
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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London, Ontario, Canada, N6A5W9
- London Health Sciences Centre
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London, Ontario, Canada, N6A4H1
- Regional Mental Health Care
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London, Ontario, Canada, N5Y4J8
- Canadian Mental Health Association (London-Middlesex Branch)
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London, Ontario, Canada, N6B1Y6
- Western Ontario Therapeutic Community Hostel
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Must be diagnosed with mood disorder or psychotic disorder for a minimum one year
- Able to make informed consent to participate in the study
- Able to understand and speak English to the degree necessary to participate in interviews/focus groups
Exclusion Criteria:
- Younger than 18 or older than 80
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Early Intervention
At Phase 1 (first 3 months of project), the 200 participants in Group 1 will be provided with a Personal Health Record (PHR) through TELUS Health Space, as well as they will be introduced to smart phone technology to ready them for deployment of the prompts and reminders.
Two months later, they will be provided with a smart phone.
|
Participants will be given their own TELUS Health Space and Smart Phone in order to have access to their personal health records.
Specific procedures using the smart phone will depend on the individual care plan for each participant.
Prompts and assessments will vary depending on participant needs.
|
EXPERIMENTAL: Later Intervention
A delayed implementation plan will be used (but will have no effect on the standard of care for the remaining 200 participants), so the remaining 200 participants in Group 2 will initially act as a control group, but at Phase 2 (six months later - approximately June 2012) the remaining 200 participants will be introduced to the technology in the same order (PHR -> Smart Phone).
Group 2 will have the benefit of any enhancements made during Phase 1 of the project.
|
Participants will be given their own TELUS Health Space and Smart Phone in order to have access to their personal health records.
Specific procedures using the smart phone will depend on the individual care plan for each participant.
Prompts and assessments will vary depending on participant needs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Lehman Quality of Life - Brief Version
Time Frame: Every 6 months for total of 18 months
|
Every 6 months for total of 18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Cheryl Forchuk, PhD, Lawson Health Research Institute; University of Western Ontario
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (ACTUAL)
June 1, 2014
Study Completion (ACTUAL)
June 1, 2014
Study Registration Dates
First Submitted
November 14, 2011
First Submitted That Met QC Criteria
November 14, 2011
First Posted (ESTIMATE)
November 17, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
March 7, 2016
Last Update Submitted That Met QC Criteria
March 4, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18451
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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