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Clinical Trials/NCT05703412
NCT05703412Enrolling By InvitationNot Applicable

Effectiveness of a Multi-component mHealth Intervention to Improve Post-hospital Transitions of Care for Patients With SMI

Butler Hospital1 site in 1 country180 target enrollmentStarted: February 14, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
180
Locations
1
Primary Endpoint
Brief Psychiatric Rating Scale (BPRS)

Study Overview

Brief Summary

The overall aim of this program of research is to improve the continuity of care for patients with serious mental illness (SMI) by supporting a safer and more efficient bridge from hospital to outpatient care using a mobile device-delivered app called Transition-FOCUS (tFOCUS), which has previously been tested in community samples. The purpose of the proposed project is to establish the effectiveness of our empirically-supported, multi-component mHealth intervention.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • psychiatric inpatient/partial hospitalization
  • diagnosis of schizophrenia-spectrum disorder or major mood disorder
  • planned ongoing mental health treatment post-discharge in the community
  • 18 years or older
  • ability to speak and read English

Exclusion Criteria

  • lack of smartphone
  • homelessness or housing instability that would prevent reliable follow-up
  • discharge to a long-term restricted living setting

Arms & Interventions

Transition-FOCUS mHealth Intervention

Experimental

All participants will download the tFOCUS app to their mobile phone. tFOCUS uses EMA to assess variables identified as being salient to treatment engagement and illness self-management. The application delivers algorithm-driven micro interventions to address reported problem(s). Data is transmitted to a clinician "dashboard," which can be used for remote monitoring.

Intervention: Transition-FOCUS mHealth Intervention (Behavioral)

Check-In

Active Comparator

Control participants will receive the currently recommended best practices of post-discharge care, including follow-up appointments, instructions, referrals and a follow-up check in.

Intervention: Check-In (Behavioral)

Outcomes

Primary Outcomes

Brief Psychiatric Rating Scale (BPRS)

Time Frame: 24 weeks

The interviewer-rated Brief Psychiatric Rating Scale is a measure of psychiatric symptom severity. The total score (sum of items) will be used to assess overall severity with scores ranging from 18 to 126 and higher scores indicating greater severity.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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