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

NCT ID: NCT03649815

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-18
• Study Completion Date: 2018-05-08

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:

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.

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Use of mHealth Technology

This single arm of the study involves the provision of the mobile health technology entitled App4Independence.

Group Type: EXPERIMENTAL

App4Independence

Intervention Type: COMBINATION_PRODUCT

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

Interventions

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

Intervention Type: COMBINATION_PRODUCT

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

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre for Addiction and Mental Health

OTHER

Sponsor Role: lead

Responsible Party

Sean Kidd

Senior Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sean Kidd, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

84-2016

Identifier Type: -

Identifier Source: org_study_id