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

Testing the Feasibility and Outcomes of a Digital Health Support for Individuals With Schizophrenia Spectrum Mental Illnesses

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

Study Overview

• Status: Completed
• Conditions: Schizophrenia Spectrum and Other Psychotic Disorders
• Intervention / Treatment: Combination product: App4Independence

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:

1. 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.
2. Daily interactions and check-in functionality for self-determination of messaging, reward messaging, social interaction content.
3. An algorithm to determine content based on ambient and interaction data content triggers and risk flagging built on evidence-based guidelines.
4. 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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 1R8
      • Centre for Addiction and Mental Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 Month
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.	1 month
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.	1 month

Collaborators and Investigators

• Sponsor: Centre for Addiction and Mental Health
• Investigators: Principal Investigator: Sean Kidd, PhD, Centre for Addiction and Mental Health

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2017
• Primary Completion (Actual): May 8, 2018
• Study Completion (Actual): May 8, 2018

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: August 24, 2018
• First Posted (Actual): August 28, 2018

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: May 22, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: schizophrenia; psychosis; mHealth; digital health
• Additional Relevant MeSH Terms: Schizophrenia; Psychotic Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders
• Other Study ID Numbers: 84-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No