- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04602741
Examining a Digital Health Approach for Advancing Schizophrenia Illness Self-management and Provider Engagement
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.
Study Overview
Status
Intervention / Treatment
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 (e.g., 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 wellness/risk 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M6R2C4
- Centre for Addiction and Mental Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants will be adults, 18 years of age or older, with a chart diagnosis of a DSM-5 schizophrenia spectrum illness confirmed by a structured diagnostic interview (SCID-5)40.
- All participants will be engaged in outpatient psychiatric treatment.
- Proficiency in English.
- Own and use an Android or iOS smartphone.
Exclusion Criteria:
- Lack of capacity with no identified substitute decision maker.
- Intellectual disability.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A4i Intervention
App4Independence (A4i) Experimental: A4i Intervention App4Independence (A4i) The study intervention is the digital health platform A4i. A4i operates on the individual's own phone with or without data. Specific A4i functionality includes:
|
6 months of the provision of A4i on the individual's own device.
Other Names:
|
No Intervention: Treatment As Usual
Treatment as usual participants will be recieving outpatient mental health care through the standard supports (most typically, case management and psychiatric support) that are available in a large, Canadian, urban centre.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment
Time Frame: 21 months.
|
Number of individuals successfully recruited into the trial.
Higher values are better with a target of 160.
|
21 months.
|
Retention
Time Frame: 27 months.
|
Number of participants retained in the study through to post-intervention evaluation.
Higher values are better.
The target is retaining 85% of participants recruited.
|
27 months.
|
Objective App Use
Time Frame: 27 months.
|
Objective A4i use metrics will be collected including information on the combined time and frequency of use for each participant.
Higher values are better.
|
27 months.
|
Incidence of Treatment-Emergent Adverse Events
Time Frame: 27 months.
|
Safety/tolerability will be assessed through information gathered via all study-related interactions with significant safety concerns operationalized as one or more critical incidents occurring in which there is evidence of an association between the incident and App use.
Lower values are better.
|
27 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
App Strengths and Limitations
Time Frame: 27 months.
|
An Research Assistant will contact treatment arm providers and participants to complete a brief, qualitative, semi-structured interview assessing strengths (generally and in clinical interactions) and limitations of A4i and any risks not otherwise reported or observed during study operations.
|
27 months.
|
Psychiatric Symptoms
Time Frame: Baseline-6 months.
|
General symptomatology will be assessed using the 53-item, 5-point likert scale Brief Symptom Inventory.
Range 0-212.
Lower values are better.
|
Baseline-6 months.
|
Medication Adherence
Time Frame: Baseline-6 months.
|
Medication adherence will be measured using the 4-item Brief Adherence Rating Scale with responses obtained by both providers and participants to assess medication adherence.
Range 0-100%.
Higher values are better.
|
Baseline-6 months.
|
Clinical Alliance
Time Frame: Baseline-6 months.
|
Provider-Patient Clinical Alliance will be assessed with Scale to Assess the Therapeutic Relationship.
This 12-item measure employing a 5-point likert scale has been used extensively in studies of outpatient care for severe mental illness.
This measure supports patient and provider versions.
Higher values are better.
Range 0-48.
|
Baseline-6 months.
|
Quality of Life: Heinrichs-Carpenter Quality of Life Scale
Time Frame: Baseline-6 months.
|
The Heinrichs-Carpenter Quality of Life Scale, has 21 items, is well validated for schizophrenia, and captures sense of purpose, motivation, emotional and social interaction, role functioning, and engagement in regular activities.
Higher values are better.
Range 0-126.
|
Baseline-6 months.
|
Schizophrenia Symptoms
Time Frame: Baseline-6 months.
|
Schizophrenia-specific symptomatology will be assessed with the Positive and Negative Syndrome Scale.
Lower values are better.
Range 30-210.
|
Baseline-6 months.
|
Schizophrenia Negative Symptoms
Time Frame: Baseline-6 months.
|
Negative symptoms assessed with the Scale for the Assessment of Negative Symptoms.
Lower values are better.
Range 0-125.
|
Baseline-6 months.
|
Treatment Adherence - General
Time Frame: Baseline-6 months.
|
The 5-item, 6-point likert scale Medical Outcomes Study general adherence scale to capture broader adherence to treatment recommendations (again triangulated with provider responses).
Higher values are better.
Range 5-26.
|
Baseline-6 months.
|
Appointment Attendence
Time Frame: Baseline-6 months.
|
The percentage of scheduled appointments attended through EMR audit at CAMH or provider report at non-CAMH sites.
Higher values are better.
|
Baseline-6 months.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 028/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Psychotic Disorders
-
Medical College of WisconsinCompletedSchizophrenia | Affective Disorders | Psychotic Disorder | Psychotic Mood Disorder
-
Søren Dinesen ØstergaardCompletedAffective Disorders, PsychoticDenmark
-
Instituto de Investigación Hospital Universitario...CompletedSchizophrenia and Disorders With Psychotic Feature | Psychotic EpisodeSpain
-
VA Office of Research and DevelopmentRecruitingMI-CBTech: A Mobile Intervention for Community Integration in Homeless-Experienced Veterans With SMIHomelessness | Schizophrenia Spectrum Disorders | Psychotic Mood Disorders | Psychotic Affective Disorders | Ill-Housed PersonsUnited States
-
University Hospital, CaenRecruiting
-
University of MinnesotaUniversity of California, San FranciscoCompletedPsychotic Disorders | Schizophrenia | Schizoaffective Disorder | Cognitive Impairment | Psychosis | Treatment | Psychotic Depression | Psychotic Episode | Active Control | Psychotic Mood DisordersUnited States
-
Instituto de Investigación Hospital Universitario...Carlos III Health Institute; European Regional Development FundCompletedSchizophrenia and Disorders With Psychotic Features | Psychotic EpisodeSpain
-
Centre hospitalier de Ville-Evrard, FranceRecruiting
-
University of California, San DiegoActive, not recruitingSchizophrenia | Schizoaffective Disorder | Mood Disorder, PsychoticUnited States
-
Boston Medical CenterNational Institute of Mental Health (NIMH); Beth Israel Deaconess Medical CenterCompletedPsychotic Disorders | Psychosis | Psychotic EpisodeUnited States
Clinical Trials on A4i Intervention
-
Hoffmann-La RocheWithdrawnMultiple SclerosisSpain, United Kingdom, Czech Republic, Canada, Germany, Slovakia, Poland, Bulgaria, Russian Federation
-
Centre for Addiction and Mental HealthRecruitingOpioid-Related Disorders | Mental Health Wellness 1 | Mobile Phone Use | Comorbidities and Coexisting Conditions | Relationship, Professional PatientCanada
-
Biolux Research Holdings, Inc.TerminatedOrthodontic Tooth MovementCanada
-
University of California, San FranciscoNational Cancer Institute (NCI)CompletedColorectal Carcinoma | Healthy Subject | Health Status UnknownUnited States
-
University of FloridaCompletedSensitivityUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); National Institute on Minority Health and...RecruitingHuman Papillomavirus InfectionUnited States
-
Ohio State University Comprehensive Cancer CenterCompleted
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnCancer Survivor | Peripheral Sensory Neuropathy
-
Nottingham Trent UniversityUnknownOverweight and ObesityUnited Kingdom
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityRecruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage IIIA Breast Cancer AJCC v8 | Prognostic... and other conditionsUnited States