Feasibility and Outcomes of a Digital Health Support for the Schizophrenia Spectrum
Primary Purpose
Schizophrenia Spectrum and Other Psychotic Disorders
Status
Completed
Phase
Early Phase 1
Locations
Canada
Study Type
Interventional
Intervention
App4Independence
Sponsored by
About this trial
This is an interventional other trial for Schizophrenia Spectrum and Other Psychotic Disorders focused on measuring schizophrenia, psychosis, mHealth, digital health
Eligibility 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:
-
Sites / Locations
- Centre for Addiction and Mental Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Use of mHealth Technology
Arm Description
This single arm of the study involves the provision of the mobile health technology entitled App4Independence.
Outcomes
Primary Outcome Measures
Symptomatology
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.
Recovery Process Engagement
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.
Treatment Adherence
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03649815
First Posted
August 23, 2018
Last Updated
May 22, 2020
Sponsor
Centre for Addiction and Mental Health
1. Study Identification
Unique Protocol Identification Number
NCT03649815
Brief Title
Feasibility and Outcomes of a Digital Health Support for the Schizophrenia Spectrum
Official Title
Testing the Feasibility and Outcomes of a Digital Health Support for Individuals With Schizophrenia Spectrum Mental Illnesses
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 18, 2017 (Actual)
Primary Completion Date
May 8, 2018 (Actual)
Study Completion Date
May 8, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
General Issues The most common contributors to relapse in schizophrenia and associated mental illnesses are medication non-adherence, social isolation, and inadequate supports. Driven to a large extent by system of care shortcomings and the many challenges presented by symptoms, the impacts of these problems are profound from individual to system levels. This is a global issue, and to date technology has not been substantively leveraged in generating solutions - despite evidence of substantial uptake of relevant technologies by relevant populations. To date, there are few products on the market that address the constellation of issues outlined above. It is an area where a nuanced approach is needed as this illness is highly diverse in presentation, attended by a number of social determinants of health that greatly affect outcomes and, quite commonly, ambivalence with respect to service provider and caregiver engagement. This scenario as it exists for schizophrenia stands in sharp contrast with the many thousands of applications developed for other mental health issues.
Cellphone Based Technologies and Schizophrenia There is a small, emergent literature that is examining the feasibility and outcomes of mobile applications that address schizophrenia. Broadly, targeted mobile and online applications in areas such as cognitive remediation (brain training games) have been found feasible and do not result in any noted risks in their use and there have been promising findings in outcome studies of emergent mHealth strategies for schizophrenia of the kind tested here.
Local Work in this Area to Date
Initial mapping of key domains relevant to an app in this area has been conducted based upon the experience of the collaborators and an understanding of the relevant practice literatures. This initial draft, which might be considered a 'paper prototype', let to the identification of the following needs:
The platform would:
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 upon evidence based strategies to enhance wellness (e.g., personalized affirmations; tip sheets; relaxation exercises)
Facilitate automated support and link to caregivers
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
Specifically, the app was designed to be made up of 4 functional areas:
A needs assessment in order to determine care/interaction pathway, crisis planning and routine builders, accompanied by ongoing assessment to keep components relevant and engaging and to facilitate treatment planning and support by providers.
Daily interactions and check-in functionality for self-determination of messaging, reward messaging, social interaction content.
An algorithm to determine content based on ambient and interaction data content triggers and risk flagging built on evidence-based guidelines.
Self-Management portal and caregiver dashboard.
Research Objective
This study was undertaken to engage in a rigorous process of feasibility testing. This will then be followed by a randomized trial of the beta version that will be generated through the process outlined in this protocol (will be the subject of a subsequent protocol and not addressed here). As such, the objective of this research is to capture and record the process of development of a functional, beta version of this technology. This test includes outcome data derived from 1 month of app use comprised of both qualitative feedback and quantitative outcome data. The objective is to determine feasibility prior to further trials and validation efforts.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia Spectrum and Other Psychotic Disorders
Keywords
schizophrenia, psychosis, mHealth, digital health
7. Study Design
Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Use of mHealth Technology
Arm Type
Experimental
Arm Description
This single arm of the study involves the provision of the mobile health technology entitled App4Independence.
Intervention Type
Combination Product
Intervention Name(s)
App4Independence
Intervention Description
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 Measure Information:
Title
Symptomatology
Description
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.
Time Frame
1 Month
Title
Recovery Process Engagement
Description
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.
Time Frame
1 month
Title
Treatment Adherence
Description
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.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Kidd, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1R8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be made available via a supplementary file in the publication.
IPD Sharing Time Frame
Available upon publication indefinitely.
IPD Sharing Access Criteria
Publically accessible.
Learn more about this trial
Feasibility and Outcomes of a Digital Health Support for the Schizophrenia Spectrum
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