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

Primary Purpose

Psychotic Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile After-Care Support (MACS) app
Sponsored by
Butler Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders focused on measuring Medication adherence, Treatment adherence, Ecological momentary assessment, Ecological momentary intervention, Coping skills, Psychiatric Hospitalization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Butler Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mobile After-Care Support (MACS) app

Arm Description

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.

Outcomes

Primary Outcome Measures

Client Satisfaction Questionnaire (CSQ)
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.

Secondary Outcome Measures

Brief Psychiatric Rating Scale (BPRS)
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.
Brief Adherence Rating Scale (BARS)
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.
Maastricht Assessment of Coping Strategies (MACS)
The MACS is an interviewer-rated assessment of the coping strategies that patients report using to manage their symptoms.

Full Information

First Posted
December 5, 2018
Last Updated
December 27, 2022
Sponsor
Butler Hospital
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03769493
Brief Title
Mobile After-Care Intervention to Support Post-Hospital Transition (MACS)
Acronym
MACS
Official Title
Mobile After-Care Support Intervention for Patients With Schizophrenia Following Hospitalization (MACS)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 16, 2019 (Actual)
Primary Completion Date
October 15, 2019 (Actual)
Study Completion Date
October 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Butler Hospital
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders
Keywords
Medication adherence, Treatment adherence, Ecological momentary assessment, Ecological momentary intervention, Coping skills, Psychiatric Hospitalization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
An uncontrolled open trial approach will be used in which all participants receive the MACS app.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile After-Care Support (MACS) app
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mobile After-Care Support (MACS) app
Intervention Description
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.
Primary Outcome Measure Information:
Title
Client Satisfaction Questionnaire (CSQ)
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Brief Psychiatric Rating Scale (BPRS)
Description
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.
Time Frame
1 month
Title
Brief Adherence Rating Scale (BARS)
Description
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.
Time Frame
1 month
Title
Maastricht Assessment of Coping Strategies (MACS)
Description
The MACS is an interviewer-rated assessment of the coping strategies that patients report using to manage their symptoms.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Currently hospitalized DSM-5 criteria for psychotic disorder (schizophrenia or schizoaffective disorder) 18 years or older Prescribed oral antipsychotic medication upon discharge Ability to speak and read English Exclusion Criteria: Alcohol/drug use disorders at moderate or severe level Planned discharge to supervised living setting or participation in formal outpatient adherence programs (e.g., medication packaging) Pregnancy or other medical condition (e.g., dementia) contraindicating use of antipsychotic medications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brandon A Gaudiano, Ph.D.
Organizational Affiliation
Butler Hospital & Brown Universit
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ethan Moitra, Ph.D.
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://nda.nih.gov/
Citations:
PubMed Identifier
32613525
Citation
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.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7775867/
Description
Development and initial testing of an mHealth transitions of care intervention for adults with schizophrenia-spectrum disorders immediately following a psychiatric hospitalization

Learn more about this trial

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

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