Mood DisorderMHENNCT01473550
Mental Health Engagement Network (MHEN)
A study testing Access to TELUS Health Space and Smart Phone in people with Mood Disorder and Psychotic Disorder, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 4 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mood Disorder, Psychotic Disorder
- What is being tested?
- Access to TELUS Health Space and Smart Phone
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 4 sitesCanada
- Study dates
- Nov 2011to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Younger than 18 or older than 80
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Canadian Mental Health Association (London-Middlesex Branch)
London, Ontario, N5Y4J8
Regional Mental Health Care
London, Ontario, N6A4H1
London Health Sciences Centre
London, Ontario, N6A5W9
Western Ontario Therapeutic Community Hostel
London, Ontario, N6B1Y6
About this study
Official title: 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.
- Conditions
- Mood Disorder, Psychotic Disorder
- Being tested
- Access to TELUS Health Space and Smart Phone
- Keywords
- Mental Health, Smart Technology, Mood disorder, Psychotic disorder
- Medical subject headings
- Mood Disorders, Psychotic Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to TELUS Health Space and Smart PhoneBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Early Intervention | Experimental | 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. Receives: Behavioral: Access to TELUS Health Space and Smart Phone |
| Later Intervention | Experimental | 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. Receives: Behavioral: Access to TELUS Health Space and Smart Phone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lehman Quality of Life - Brief Version
Measured: Every 6 months for total of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mood DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- London Health Sciences Centre, Canadian Mental Health Association, St. Joseph's Health Care London
- Responsible party
- Principal investigator, Cheryl Forchuk, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Cheryl Forchuk, PhD, Principal investigator, Lawson Health Research Institute; University of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473550
- Sponsor's protocol ID
- 18451
- Acronym
- MHEN
- Status last verified
- Mar 2016
- First submitted
- 14 Nov 2011
- Last updated
- 7 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Forchuk C, Donelle L, Ethridge P, Warner L. Client Perceptions of the Mental Health Engagement Network: A Secondary Analysis of an Intervention Using Smartphones and Desktop Devices for Individuals Experiencing Mood or Psychotic Disorders in Canada. JMIR Ment Health. 2015 Jan 21;2(1):e1. doi: 10.2196/mental.3926. eCollection 2015 Jan-Mar.
PubMed 26543906
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Health Engagement Network (MHEN): Connecting Clients With Their Health Team
- ClinicalTrials.gov ID
- NCT01473550
- Acronym / sponsor ID
- MHEN / 18451
- Conditions
- Mood Disorder, Psychotic Disorder
- Keywords
- Mental Health, Smart Technology, Mood disorder, Psychotic disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- London Health Sciences Centre, Canadian Mental Health Association, St. Joseph's Health Care London
- Study start
- Nov 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 17 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Intervention | Experimental | Behavioral: Access to TELUS Health Space and Smart PhoneAt 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. |
| Later Intervention | Experimental | Behavioral: Access to TELUS Health Space and Smart PhoneA 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Younger than 18 or older than 80
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Access to TELUS Health Space and Smart PhoneParticipants 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. | Behavioural | Early Intervention, Later Intervention |
Primary outcome
Lehman Quality of Life - Brief Version
Time frame: Every 6 months for total of 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2016.
- Derived from this study: PubMed 26543906Forchuk C, Donelle L, Ethridge P, Warner L. Client Perceptions of the Mental Health Engagement Network: A Secondary Analysis of an Intervention Using Smartphones and Desktop Devices for Individuals Experiencing Mood or Psychotic Disorders in Canada. JMIR Ment Health. 2015 Jan 21;2(1):e1. doi: 10.2196/mental.3926. eCollection 2015 Jan-Mar.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheryl Forchuk, PhD principal investigator
Lawson Health Research Institute; University of Western Ontario
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access to TELUS Health Space and Smart Phone in people with Mood Disorder and Psychotic Disorder, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lehman Quality of Life - Brief Version (time frame: Every 6 months for total of 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01473550, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2016.