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

Psychotic Disorders Clinical Trial

— MACS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03769493
• Other study ID #: 1806-001
• Secondary ID: R34MH115144
• Status: Completed
• Phase: N/A
• Start date: January 16, 2019
• Est. completion date: October 15, 2019

Study information

• Verified date: December 2022
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 15, 2019
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month
Secondary	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.	1 month
Secondary	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.	1 month
Secondary	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.	1 month

External Links

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