- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05703412
Effectiveness of mHealth Post-discharge Intervention for Patients With Severe Mental Illness (tFOCUS)
April 24, 2023 updated by: Butler Hospital
Effectiveness of a Multi-component mHealth Intervention to Improve Post-hospital Transitions of Care for Patients With SMI
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 Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
180
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Toni Amaral
- Phone Number: 401-455-6476
- Email: tamaral@butler.org
Study Locations
-
-
Rhode Island
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Providence, Rhode Island, United States, 02916
- Butler Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: Transition-FOCUS mHealth Intervention
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.
|
tFOCUS integrates evidence-based strategies for self-management of severe mental illness (SMI) into a comprehensive mobile assessment and treatment system that is grounded in theoretical SMI models.
The application promotes self-management strategies aimed at improving medication adherence to manage biologically driven psychiatric symptoms, increase social support to reduce the negative impact of social withdrawal, improve sleep hygiene to reduce levels of fatigue, and promote strategies for coping with persistent symptoms.
tFOCUS application strategies are linked to participants' specific assessment responses, allowing for a highly personalized self-management intervention experience
Other Names:
|
Active Comparator: Check-In
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.
|
Check-in includes a discharge and safety plan (with medication instructions, crisis services, etc.), a timely follow-up appointment with a mental health provider, and phone check-ins by case managers immediately following post-discharge for care coordination purposes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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24 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recovery Assessment Scale (RAS)
Time Frame: 24 weeks
|
The RAS is a self-report measure of aspects of mental health recovery, including hope and self-determination.
The total score (sum of items) will be used and ranges from 22 to 110 with higher scores indicating higher suicidal thoughts and behaviors.
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 14, 2023
Primary Completion (Anticipated)
July 31, 2027
Study Completion (Anticipated)
July 31, 2027
Study Registration Dates
First Submitted
January 19, 2023
First Submitted That Met QC Criteria
January 19, 2023
First Posted (Actual)
January 30, 2023
Study Record Updates
Last Update Posted (Actual)
April 25, 2023
Last Update Submitted That Met QC Criteria
April 24, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2208-001
- R01MH130496 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data will be uploaded to the NIMH Data Archive.
IPD Sharing Time Frame
De-identified data will be available after the project is completed without time limit.
IPD Sharing Access Criteria
See guidelines of the NIMH Data Archive.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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