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

December 27, 2022 updated by: Brandon Gaudiano, Butler Hospital

Mobile After-Care Support Intervention for Patients With Schizophrenia Following Hospitalization (MACS)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

10

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 Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Butler Hospital

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

Genders Eligible for Study

All

Description

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.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Client Satisfaction Questionnaire (CSQ)
Time Frame: 1 month
The Client Satisfaction Questionnaire is a self-report measure of patient satisfaction with treatment. The total score will be used and ranges from 8 to 32 with increased scores indicating greater satisfaction with treatment.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Psychiatric Rating Scale (BPRS)
Time Frame: 1 month
The interviewer-rated BPRS is a measure of psychiatric symptom severity. The total score will be used to assess overall severity with scores ranging from 18 to 126 and higher scores indicating greater severity.
1 month
Brief Adherence Rating Scale (BARS)
Time Frame: 1 month
The BARS assesses the percentage of missed medication doses over the past month. The total adherence score ranges from 0% to 100% and higher scores indicate greater adherence.
1 month
Maastricht Assessment of Coping Strategies (MACS)
Time Frame: 1 month
The MACS is an interviewer-rated assessment of the coping strategies that patients report using to manage their symptoms.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Butler Hospital

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Brandon A Gaudiano, Ph.D., Butler Hospital & Brown Universit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

January 16, 2019

Primary Completion (Actual)

October 15, 2019

Study Completion (Actual)

October 15, 2019

Study Registration Dates

First Submitted

December 5, 2018

First Submitted That Met QC Criteria

December 6, 2018

First Posted (Actual)

December 7, 2018

Study Record Updates

Last Update Posted (Estimate)

January 19, 2023

Last Update Submitted That Met QC Criteria

December 27, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1806-001
  • R34MH115144 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data available on the National Institute of Mental Health Data Archive (NDA).

IPD Sharing Time Frame

Currently available.

IPD Sharing Access Criteria

See NDA web site for details.

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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