Clinical trial NCT04602741: Examining a Digital Health Approach for Advancing Schizophrenia Illness Self-management and Provider Engagement
Official title: Examining a Digital Health Approach for Advancing Schizophrenia Illness Self-management and Provider Engagement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizo Affective Disorder
Psychotic Disorders
Keywords: Digital Health
Mobile Health
Smartphone
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2020-10-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. All participants will be engaged in outpatient psychiatric treatment.
3. Proficiency in English.
4. Own and use an Android or iOS smartphone.

Exclusion Criteria:

1. Lack of capacity with no identified substitute decision maker.
2. Intellectual disability.

Primary outcomes:
measure: Recruitment
timeFrame: 21 months.
measure: Retention
timeFrame: 27 months.
measure: Objective App Use
timeFrame: 27 months.
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 27 months.
Secondary outcomes:
measure: App Strengths and Limitations
timeFrame: 27 months.
measure: Psychiatric Symptoms
timeFrame: Baseline-6 months.
measure: Medication Adherence
timeFrame: Baseline-6 months.
measure: Clinical Alliance
timeFrame: Baseline-6 months.
measure: Quality of Life: Heinrichs-Carpenter Quality of Life Scale
timeFrame: Baseline-6 months.
measure: Schizophrenia Symptoms
timeFrame: Baseline-6 months.
measure: Schizophrenia Negative Symptoms
timeFrame: Baseline-6 months.
measure: Treatment Adherence - General
timeFrame: Baseline-6 months.
measure: Appointment Attendence
timeFrame: Baseline-6 months.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
References: