Ignite Creation Date:
2024-05-06 @ 3:20 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04602741
Status:
COMPLETED
Last Update Posted:
2023-09-01
First Post:
2020-10-01
Brief Title:
Examining a Digital Health Approach for Advancing Schizophrenia Illness Self-management and Provider Engagement
Sponsor:
Centre for Addiction and Mental Health
Organization:
Centre for Addiction and Mental Health
Study Overview
Official Title:
Examining a Digital Health Approach for Advancing Schizophrenia Illness Self-management and Provider Engagement
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The effective treatment of schizophrenia is very challenging due to a number of factors
These include issues such as poor engagement with treatment plans and care providers limited contacts with providers due to under-resourced health services and the challenges inherent to schizophrenia symptoms The outcomes of these problems include frequent lengthy and costly hospital readmissions low quality of life high levels of distress and difficulties engaging in valued community roles Digital Health technologies are a promising model to help address these problems They are a low cost and accessible form of support and have not been substantively developed or studied for people with schizophrenia spectrum illnesses In this study the feasibility of one such technology that is in development will be tested App4Independence A4i A4i provides customized coping prompts peer-peer networking and a portal that facilitates better provider engagement This research will provide critical information in the development of this new technology to address a key problem in the field - how to enhance care in a resource-limited context where provider-patient contacts are brief infrequent and rely on in the moment recall and self-advocacy by patients These findings will lay the groundwork for a larger program of research and software development that will i validate the technology across multiple sites and ii catalyze engagement with healthcare systems and caregiver networks to scale-out access to this promising resource
These include issues such as poor engagement with treatment plans and care providers limited contacts with providers due to under-resourced health services and the challenges inherent to schizophrenia symptoms The outcomes of these problems include frequent lengthy and costly hospital readmissions low quality of life high levels of distress and difficulties engaging in valued community roles Digital Health technologies are a promising model to help address these problems They are a low cost and accessible form of support and have not been substantively developed or studied for people with schizophrenia spectrum illnesses In this study the feasibility of one such technology that is in development will be tested App4Independence A4i A4i provides customized coping prompts peer-peer networking and a portal that facilitates better provider engagement This research will provide critical information in the development of this new technology to address a key problem in the field - how to enhance care in a resource-limited context where provider-patient contacts are brief infrequent and rely on in the moment recall and self-advocacy by patients These findings will lay the groundwork for a larger program of research and software development that will i validate the technology across multiple sites and ii catalyze engagement with healthcare systems and caregiver networks to scale-out access to this promising resource
Detailed Description:
Problem Statement Among schizophrenia-spectrum populations adherence to treatment is poor community-based supports are limited and efforts to foster illness self-management have had limited success These challenges contribute to frequent lengthy and costly hospital readmissions and poor functional outcomes Digital health strategies in turn hold considerable promise in the effort to address these problems Across healthcare domains digital health is a rapidly growing area due to its potential reach accessibility low cost and implications for the use of data to customize treatments and identify risk trajectories Despite this promise and for reasons that are not entirely clear the development and study of digital health strategies for more severe mental health conditions such as schizophrenia is much less developed than other domains of healthcare
Objective This feasibility trial will examine a digital health platform designed to enhance illness self-management and treatment engagement for individuals with schizophrenia
Technology The investigators and collaborators have developed and piloted a digital technology called App4Independence A4i This platform was designed to i help prevent social isolation through behavioral activation prompts and peer-peer strategy sharing ii enhance coping with schizophrenia symptoms through functions that draw on evidence-based strategies eg texted tips derived from cognitive and behavioral therapies and provide a novel technology that assists with the identification of auditory hallucinations iii enhance treatment adherence through scheduling text and reminder functions iv track level of wellnessrisk and progress on personal goals through both active self-ratings and passive sleep monitoring proxy metrics and v facilitate communications with care providers through a provider dashboard summarizing platform-collected data gathered between appointments
Partners This study builds on a partnership between the Centre for Addiction and Mental Health research capability mental health service and associated expertise access to patient populations and MEMOTEXT a health technology company with a track record of success in digital health approaches across multiple health conditions and care contexts
Study Design This single blind randomized controlled trial examines the feasibility of A4i Feasibility metrics include study recruitment and retention rate of technology use safety and utility in clinical interactions Other outcome metrics include symptomatology treatment adherence patient-provider alliance and quality of life In this trial study participants will be randomized to either treatment or control conditions with pre-post outcomes measured over a 6-month period
Implications This research will provide critical information for the development of this new technology in the larger effort to address a key problem in the schizophrenia field - how to leverage technology to enhance illness self-management and care engagement in resource-limited service contexts These findings will lay the groundwork for larger trials assessing the impacts of A4i on hospital readmission and functioning - providing essential evidence for commercialization and expanded access to this tool This work is at the forefront of international efforts to explore and validate digital health approaches for schizophrenia
Objective This feasibility trial will examine a digital health platform designed to enhance illness self-management and treatment engagement for individuals with schizophrenia
Technology The investigators and collaborators have developed and piloted a digital technology called App4Independence A4i This platform was designed to i help prevent social isolation through behavioral activation prompts and peer-peer strategy sharing ii enhance coping with schizophrenia symptoms through functions that draw on evidence-based strategies eg texted tips derived from cognitive and behavioral therapies and provide a novel technology that assists with the identification of auditory hallucinations iii enhance treatment adherence through scheduling text and reminder functions iv track level of wellnessrisk and progress on personal goals through both active self-ratings and passive sleep monitoring proxy metrics and v facilitate communications with care providers through a provider dashboard summarizing platform-collected data gathered between appointments
Partners This study builds on a partnership between the Centre for Addiction and Mental Health research capability mental health service and associated expertise access to patient populations and MEMOTEXT a health technology company with a track record of success in digital health approaches across multiple health conditions and care contexts
Study Design This single blind randomized controlled trial examines the feasibility of A4i Feasibility metrics include study recruitment and retention rate of technology use safety and utility in clinical interactions Other outcome metrics include symptomatology treatment adherence patient-provider alliance and quality of life In this trial study participants will be randomized to either treatment or control conditions with pre-post outcomes measured over a 6-month period
Implications This research will provide critical information for the development of this new technology in the larger effort to address a key problem in the schizophrenia field - how to leverage technology to enhance illness self-management and care engagement in resource-limited service contexts These findings will lay the groundwork for larger trials assessing the impacts of A4i on hospital readmission and functioning - providing essential evidence for commercialization and expanded access to this tool This work is at the forefront of international efforts to explore and validate digital health approaches for schizophrenia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None