Examining a Digital Health Approach for Advancing Schizophrenia Illness Self-management and Provider Engagement

NCT04602741 | Completed Results DMC

• 1 other identifier: 028/2020
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizo Affective Disorder; Psychotic Disorders

Keywords

Digital Health; Mobile Health; Smartphone

Outcome Measures

Primary Outcomes (5)

• Recruitment

  Number of individuals successfully recruited into the trial with a target of 91.

  Through recruitment process an average of 1 week during a 21 month recruitment period.

• Retention

  Number of participants retained in the study through to post-intervention evaluation. The target is retaining 85% of participants recruited.

  6 months per participant in a 27 month period.

• App Interactions

  Number of interactions with the app will be collected including information on the combined time and frequency of use for each participant.

  Up to 6 months.

• Incidence of Treatment-Emergent Adverse Events

  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.

  Up to 6 months.

• App Likes

  Total number of posts liked for each participant will be collected.

  Up to 6 months.

Secondary Outcomes (11)

• BSI: Psychiatric Symptoms

  Baseline-6 months.

• BARS: Medication Adherence

  Baseline-6 months.

• STAR-P: Patient Relationship With Clinician

  Baseline-6 months.

• QLS: Heinrichs-Carpenter Quality of Life Scale

  Baseline-6 months.

• PANSS: Schizophrenia Symptoms

  Baseline-6 months.

Study Arms (2)

A4i Intervention

EXPERIMENTAL

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: * Addressing social isolation and cognitive challenges through personalized prompts, scheduling of activities, and connections to a range of resources. * Fostering illness self-management through evidence-informed content. * A peer-peer engagement platform that facilitates strategy/tip sharing between users (anonymous and moderated). * Daily wellness and goal attainment check-ins. * An ambient sound detector with an oscilloscope-type indicator that assists individuals with auditory hallucinations separate hallucinations from real sounds. * Passively collected data on phone use as a proxy for sleep. * A provider dashboard. Both control and experimental condition participants will be receiving standard outpatient care (TAU).

Behavioral: A4i Intervention

Treatment As Usual

NO INTERVENTION

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.

Interventions

A4i Intervention BEHAVIORAL

6 months of the provision of A4i on the individual's own device.

Also known as: A4i

A4i Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6R2C4, Canada

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Sean Kidd
• Organization: Centre for Addiction and Mental Health

Sean.Kidd@camh.ca

416-535-8501

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blocked randomization, stratified by gender, will be employed to ensure balance in sample size between treatment and control groups and gender representation. Stratification by study site (CAMH versus community agency) will also be undertaken to determine feasibility questions that may differ as a function of same. REDCap will be employed and will allocate based on the computer-generated randomization list. Allocation concealment will be achieved since the person making the assignment will have no awareness or control over the randomization schedule.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: October 26, 2020
• Study Start: January 4, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: May 22, 2026
• Results First Posted: May 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: These data will be provided after the publication of study results.

Locations

CA (1)