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Evaluate the Value of Telehomecare for Mental Health

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ClinicalTrials.gov Identifier: NCT02896894
Recruitment Status : Completed
First Posted : September 12, 2016
Last Update Posted : September 14, 2017
Sponsor:
Collaborators:
Lakeridge Health Corporation
Ontario Shores Centre for Mental Health Sciences
Ontario Telemedicine Network (OTN)
Information provided by (Responsible Party):
Women's College Hospital

Brief Summary:
This is a mixed methods study that evaluates the effectiveness of the Big White Wall (BWW) online community and its implementation in 3 hospital/health system sites across Ontario. The 6 month study includes 1000 participants that are randomized to an immediate treatment group or a delayed treatment group. The primary outcome includes a change in total and subscale scores on the Recovery Assessment Scale. Qualitative interviews with various stakeholders will explore issues relating to successful implementation.

Condition or disease Intervention/treatment Phase
Mental Disorders Other: Big White Wall (BWW) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 975 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Evaluate the Value of Telehomecare for Mental Health
Study Start Date : July 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: Immediate Treatment Group
The Immediate Treatment Group will receive access to the study intervention - the Big White Wall, immediately after consenting for a total duration of 3 months.
Other: Big White Wall (BWW)
The BWW is an internet-based intervention that incorporates several elements of mental health care that have been shown to be effective, in a virtual environment that provides anonymity (see www.bigwhitewall.com). The on-line portal gives users access to self-assessment tools to track symptoms for a wide range of conditions over time, educational materials, a social network that allows communication between people who may have similar problems, and access to on-line courses. The service is monitored at all times by "Wall Guides" to ensure that users are responded to and that the content posted is appropriate and safe.

Delayed Treatment Group
The Delayed Treatment Group will have no access to the study intervention - the Big White Wall for the first 3 months, then receive access to the BWW for 3 consecutive months.
Other: Big White Wall (BWW)
The BWW is an internet-based intervention that incorporates several elements of mental health care that have been shown to be effective, in a virtual environment that provides anonymity (see www.bigwhitewall.com). The on-line portal gives users access to self-assessment tools to track symptoms for a wide range of conditions over time, educational materials, a social network that allows communication between people who may have similar problems, and access to on-line courses. The service is monitored at all times by "Wall Guides" to ensure that users are responded to and that the content posted is appropriate and safe.

Experimental: Immediate Treatment Group - Extension
Immediate Treatment Group participants who opt in to the nested study and are randomized to the The Immediate Treatment Group - Extension, will receive access to the Big White Wall for an additional 3 months (months 4-6), immediately after receiving the initial 3 months of access.
Other: Big White Wall (BWW)
The BWW is an internet-based intervention that incorporates several elements of mental health care that have been shown to be effective, in a virtual environment that provides anonymity (see www.bigwhitewall.com). The on-line portal gives users access to self-assessment tools to track symptoms for a wide range of conditions over time, educational materials, a social network that allows communication between people who may have similar problems, and access to on-line courses. The service is monitored at all times by "Wall Guides" to ensure that users are responded to and that the content posted is appropriate and safe.

No Intervention: Immediate Treatment Group - No Extension
Immediate Treatment Group participants who opt in to the nested study and are randomized to The Immediate Treatment Group - No extension, will not receive extended access to the Big White Wall.



Primary Outcome Measures :
  1. Recovery Assessment Scale - Revised [ Time Frame: 3 months ]
    Mental health recovery, outcome is total score.


Secondary Outcome Measures :
  1. PHQ-9 [ Time Frame: 3 months ]
    PHQ-9 assesses symptoms of depression, outcome is total score.

  2. GAD-7 [ Time Frame: 3 months ]
    GAD-7 assesses symptoms of generalized anxiety, outcome is total score.

  3. Community Integration Questionnaire (CIQ) [ Time Frame: 3 months ]
    Community integration questionnaires assesses home, social, and work integration. Outcome is total and subscale scores.

  4. EQ-5D-5L- 5 dimension score [ Time Frame: 3 months ]
    Quality of life, outcome is the total score across the five dimensions

  5. EQ-5D-5L - VAS [ Time Frame: 3 months ]
    Quality of life Visual Analogue Scale (VAS) score.

  6. Recovery Assessment Scale - Revised, Subscales [ Time Frame: 3 months ]
    RAS-r Subscales, total score on 5 subscales: 1) personal confidence and hope, 2) willingness to ask for help, 3) goal and success orientation, 4) reliance on others, and 5) not dominated by symptoms.


Other Outcome Measures:
  1. Adapted Client Service Receipt Inventory (CSRI) [ Time Frame: 3 months and 6 months (ITG) ]
    Use of hospital, community and home services, self-help resources, medication, and out of pocket costs of care.

  2. Utilization of BWW [ Time Frame: 3 Months (ITG) and 6 months (DTG) ]
    Rate of utilization of BWW including: logins (number; time of day; average length and/or total time on site), activity (number of comments in talkabouts, number of bricks and brick comments, number of useful stuff pages viewed), guided support (number and type of courses taken, test scores - where tests are compulsory), and support network (results with dates).

  3. Emergency room visits [ Time Frame: 3 months and 6 months (ITG) ]
    Extracted from health administrative data

  4. Hospital admissions [ Time Frame: 3 months and 6 months (ITG) ]
    Extracted from health administrative data

  5. Outpatient health care visits [ Time Frame: 3 months and 6 months (ITG) ]
    Extracted from health administrative data

  6. Health care utilization costs [ Time Frame: 3 months and 6 months (ITG) ]
    Calculated from health administrative data and patient reported out-of-pocket costs

  7. BWW Satisfaction [ Time Frame: 3 months (ITG) and 6 months (DTG) ]
    Rating scale of satisfaction with the intervention.

  8. Recovery Assessment Scale - Revised [ Time Frame: 6 months (ITG) ]
    Mental health recovery, outcome is total score.

  9. PHQ-9 [ Time Frame: 6 months (ITG) ]
    PHQ-9 assesses symptoms of depression, outcome is total score.

  10. GAD-7 [ Time Frame: 6 months (ITG) ]
    GAD-7 assesses symptoms of generalized anxiety, outcome is total score.

  11. Community Integration Questionnaire (CIQ) [ Time Frame: 6 months (ITG) ]
    Community integration questionnaires assesses home, social, and work integration. Outcome is total and subscale scores.

  12. EQ-5D-5L- 5 dimension score [ Time Frame: 6 months (ITG) ]
    Quality of life, outcome is the total score across the five dimensions

  13. EQ-5D-5L - VAS [ Time Frame: 6 months (ITG) ]
    Quality of life Visual Analogue Scale (VAS) score.

  14. Recovery Assessment Scale - Revised, Subscales [ Time Frame: 6 months (ITG) ]
    RAS-r Subscales, total score on 5 subscales: 1) personal confidence and hope, 2) willingness to ask for help, 3) goal and success orientation, 4) reliance on others, and 5) not dominated by symptoms.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 16 or older
  2. Referred or assessed for a mental health problem (any diagnosis may be considered, but main target is individuals with mood or anxiety symptoms and related difficulties)
  3. Able to provide informed consent
  4. Willing and able to access an on-line mental health intervention
  5. Has or is willing to obtain and use an email address (the study can support participants to get access to an email address if needed)
  6. Able to read English
  7. Able to navigate an on-line tool independently or with minimal assistance

    If relevant:

  8. Being discharged from the emergency department (ED) or prompt care clinic
  9. Clinician assessing patient feels the BWW may be useful (applies to ED and prompt care)

Exclusion Criteria:

1. Symptoms or behaviours that the assessing clinician feels may be disruptive or negatively impactful for the individual or others on the BWW


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02896894


Locations
Canada, Ontario
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2
Sponsors and Collaborators
Women's College Hospital
Lakeridge Health Corporation
Ontario Shores Centre for Mental Health Sciences
Ontario Telemedicine Network (OTN)
Investigators
Principal Investigator: Sacha Bhatia, MD, FRCP(C) Women's College Hospital Institute for Health System Solutions and Virtual Care (WIHV)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Women's College Hospital
ClinicalTrials.gov Identifier: NCT02896894     History of Changes
Other Study ID Numbers: 2016-0019-E
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: There are agreements in place to share individual participant data between all the study sites and Women's College Hospital.

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders