N/A
N=91
Examining a Digital Health Approach for Advancing Schizophrenia Illness Self-management and Provider Engagement
Schizophrenia · Schizo Affective Disorder · Psychotic Disorders
Bottom Line
View on ClinicalTrials.gov: NCT04602741 ↗Enrolled (actual)
91
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Recruitment — 91 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- A4i Intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Centre for Addiction and Mental Health
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment |
91 | — |
| PRIMARY Retention |
26; 41 | — |
| PRIMARY App Interactions |
14.9 | — |
| PRIMARY Incidence of Treatment-Emergent Adverse Events |
0; 0 | — |
| PRIMARY App Likes |
24.6 | — |
| SECONDARY BSI: Psychiatric Symptoms |
53.0; 61.5; 39.4; 53.3; -13.7; -7.4 | — |
| SECONDARY BARS: Medication Adherence |
17; 23; 3; 3; 23; 22 | — |
| SECONDARY STAR-P: Patient Relationship With Clinician |
39.3; 37.0; 38.0; 36.1; -0.9; -1.9 | — |
| SECONDARY QLS: Heinrichs-Carpenter Quality of Life Scale |
77.4; 79.2; 63.2; 70.1; -4.6; 4.2 | — |
| SECONDARY PANSS: Schizophrenia Symptoms |
54.0; 56.1; 48.0; 45.1; -6.1; -10.2 | — |
| SECONDARY GAIN-SS |
5.1; 5.8; 3.3; 5.1; -1.2; 0.2 | — |
| SECONDARY MOS: Treatment Adherence - General |
25.5; 23.2; 23.2; 23.0; -2.1; -0.5 | — |
| SECONDARY Appointment Attendance |
82; 84; 11; 9 | — |
| SECONDARY STAR-C: Clinician Relationship With Patient |
36.2; 36.9; 20.8; 17.4; -3.2; -0.9 | — |
| SECONDARY SUH - Patients |
5.3; 3.8; 1.8; 4.2; 3.6; 3.9 | — |
| SECONDARY SUH - Clinicians |
1.1; 0.8; 1.7; 1.7; 6.4; 8.1 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04602741). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.