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Feasibility and Outcomes of a Digital Health Support for the Schizophrenia Spectrum

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03649815
Recruitment Status : Completed
First Posted : August 28, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Sean Kidd, Centre for Addiction and Mental Health

Brief Summary:
This protocol describes an attempt to capture the development phase of a mobile support for individuals with schizophrenia. The intent is to describe and account for a rigorous development process that will result in the creation of a beta version that would be tested in a randomized trial for effectiveness - to be addressed in a subsequent protocol

Condition or disease Intervention/treatment Phase
Schizophrenia Spectrum and Other Psychotic Disorders Combination Product: App4Independence Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Testing the Feasibility and Outcomes of a Digital Health Support for Individuals With Schizophrenia Spectrum Mental Illnesses
Actual Study Start Date : April 18, 2017
Actual Primary Completion Date : May 8, 2018
Actual Study Completion Date : May 8, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Use of mHealth Technology
This single arm of the study involves the provision of the mobile health technology entitled App4Independence.
Combination Product: App4Independence

The mobile, app-based platform was designed to:

  • Help prevent social isolation through personalized prompts, scheduling of activities, and connections to a range of resources relevant to social engagement
  • Enhance hopeful and informed engagement in the recovery process through functions that foster resilience and draw on evidence based strategies to enhance wellness (e.g., personalized affirmations; tip sheets; relaxation exercises)
  • Encourage and check-in on daily essential activities for patients - addressing memory, attention, and initiation challenges that often occur as a part of this illness
  • Provide basic health/safety functionality and track level of wellness
  • Provide an anonymous peer-peer online network for strategy sharing
  • Provide an ambient sound detector to assist with identifying hallucinations




Primary Outcome Measures :
  1. Symptomatology [ Time Frame: 1 Month ]
    The Brief Symptom Inventory (BSI) assesses the level of psychiatric symptomatology providing both total and subscale scores. All 53 items are 5-point likert with higher scores meaning higher symptomatology. For the overall score the total is used and can range from 0-212. Total scores from each of the 9 subscales are similarly used with higher scores meaning greater subscale symptomatology. Lowest scores for all are 0, with 20 the highest score for hostility, phobic anxiety, paranoid ideation, psychoticism; 16 the highest score for interpersonal sensitivity; 24 the highest for obsessive compulsive, depression, anxiety; and 28 for somatization.

  2. Recovery Process Engagement [ Time Frame: 1 month ]
    Personal Recovery Outcome Measure (PROM) was used to assess degree of engagement in the recovery process. The prom has 30 items, all 5 point likert with higher scores meaning more recovery engagement. The metric is the total score (0-120)/4 to provide an adjusted score. There are no subscales.

  3. Treatment Adherence [ Time Frame: 1 month ]
    Brief Adherence Rating Scale (BARS) was used to examine implications of A4i for medication use. A total score ranging from 0-100 is provided with 100 indicating better adherence.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Are 18 years of age or older
  • Have a schizophrenia spectrum diagnosis
  • Own and regularly use a smart phone equipped with an Android operating system and a talk and data plan
  • Read and speak conversational English

Exclusion Criteria:

-


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): NCT03649815


Locations
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Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
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Principal Investigator: Sean Kidd, PhD Centre for Addiction and Mental Health

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Responsible Party: Sean Kidd, Senior Scientist, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT03649815    
Other Study ID Numbers: 84-2016
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be made available via a supplementary file in the publication.
Supporting Materials: Study Protocol
Time Frame: Available upon publication indefinitely.
Access Criteria: Publically accessible.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sean Kidd, Centre for Addiction and Mental Health:
schizophrenia
psychosis
mHealth
digital health
Additional relevant MeSH terms:
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Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders