Mobile After-Care Intervention to Support Post-Hospital Transition (MACS)

NCT ID: NCT03769493

Last Updated: 2023-01-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-16

Study Completion Date

2019-10-15

Brief Summary

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This study examines the feasibility and acceptability of a mobile device-delivered app, called Mobile After-Care Support (MACS), to improve patients' coping and treatment adherence following a hospitalization related to their psychotic-spectrum disorder.

Detailed Description

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In the open trial, all participants will receive a study-developed app to be used on a mobile phone. This app will support the use of healthy coping skills post-hospitalization, as well as help participants adhere to their discharge treatment plan. This phase is intended to inform the feasibility and acceptability of the app in preparation for a future randomized controlled trial.

Conditions

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Psychotic Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

An uncontrolled open trial approach will be used in which all participants receive the MACS app.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mobile After-Care Support (MACS) app

All participants will download the MACS app to their mobile phone (or a study provided phone, as needed). The app runs through the third-party platform, mEMA, designed by Ilumivu. It is designed to prompt engagement through questions and tailored responses at multiple times throughout the day and provide brief interventions.

Group Type EXPERIMENTAL

Mobile After-Care Support (MACS) app

Intervention Type BEHAVIORAL

The MACS app assesses and intervenes by fostering increased treatment adherence (medication/appointments) and self-coping with illness (active, planned, problem-solving focused) to reduce symptoms and improve functioning. Additionally, MACS encourages participants who are already reporting adherence and healthy coping by using positive reinforcement strategies to maintain efforts and promote additional goal setting. MACS app strategies are linked to participants' specific assessment responses, allowing for a highly personalized self-management intervention experience. The MACS app provides interactive exercises delivered by the device designed to teach patients coping skills that they can use now and in the future.

Interventions

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Mobile After-Care Support (MACS) app

The MACS app assesses and intervenes by fostering increased treatment adherence (medication/appointments) and self-coping with illness (active, planned, problem-solving focused) to reduce symptoms and improve functioning. Additionally, MACS encourages participants who are already reporting adherence and healthy coping by using positive reinforcement strategies to maintain efforts and promote additional goal setting. MACS app strategies are linked to participants' specific assessment responses, allowing for a highly personalized self-management intervention experience. The MACS app provides interactive exercises delivered by the device designed to teach patients coping skills that they can use now and in the future.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Currently hospitalized
2. DSM-5 criteria for psychotic disorder (schizophrenia or schizoaffective disorder)
3. 18 years or older
4. Prescribed oral antipsychotic medication upon discharge
5. Ability to speak and read English

Exclusion Criteria

1. Alcohol/drug use disorders at moderate or severe level
2. Planned discharge to supervised living setting or participation in formal outpatient adherence programs (e.g., medication packaging)
3. Pregnancy or other medical condition (e.g., dementia) contraindicating use of antipsychotic medications.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Butler Hospital

OTHER

Sponsor Role lead

Responsible Party

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Brandon Gaudiano

Research Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brandon A Gaudiano, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Butler Hospital & Brown Universit

Ethan Moitra, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

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Butler Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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Moitra E, Park HS, Gaudiano BA. Development and Initial Testing of an mHealth Transitions of Care Intervention for Adults with Schizophrenia-Spectrum Disorders Immediately Following a Psychiatric Hospitalization. Psychiatr Q. 2021 Mar;92(1):259-272. doi: 10.1007/s11126-020-09792-9.

Reference Type RESULT
PMID: 32613525 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7775867/

Development and initial testing of an mHealth transitions of care intervention for adults with schizophrenia-spectrum disorders immediately following a psychiatric hospitalization

Other Identifiers

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R34MH115144

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1806-001

Identifier Type: -

Identifier Source: org_study_id

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