Effectiveness of mHealth Post-discharge Intervention for Patients With Severe Mental Illness
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transition-FOCUS mHealth Intervention, Check-In.
- Who it may be relevant to
- Registry conditions: Bipolar Disorder, Major Depression, Schizophrenia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of a Multi-component mHealth Intervention to Improve Post-hospital Transitions of Care for Patients With SMI
Overview
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.
Interventions
- Behavioral Transition-FOCUS mHealth Intervention
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 cop - Behavioral 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.
Primary outcome measures
- Brief Psychiatric Rating Scale (BPRS) [Time frame: 24 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Butler Hospital — Providence
Publications
- Moitra E, Amaral TM, Benz MB, Cambow S, Elwy AR, Kunicki ZJ, Lu Z, Rafferty NS, Rabasco A, Rossi R, Schatten HT, Gaudiano BA. A Hybrid Type 1 trial of a multi-component mHealth intervention to improve post-hospital transitions of care for patients with serious mental illness: Study protocol. Contemp Clin Trials. 2024 Apr;139:107481. doi: 10.1016/j.cct.2024.107481. Epub 2024 Mar 1. PMID 38431134
Identifiers
NCT: NCT05703412 · 2208-001 · R01MH130496