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

Not Applicable

Completed

• Conditions: Psychotic Disorders
• Interventions: Behavioral: Mobile After-Care Support (MACS) app

• Registration Number: NCT03769493
• Lead Sponsor: Butler Hospital

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.

Study Timeline

• Study First Submitted: 2018-12-05
• Study First Submitted QC: 2018-12-06
• Study First Posted: 2018-12-07
• Study Start: 2019-01-16
• Primary Completion: 2019-10-15
• Study Completion: 2019-10-15
• Status Verified: 2022-12
• Results First Submitted: 2022-12-06
• Results First Submitted QC: 2022-12-27
• Last Update Submitted: 2022-12-27
• Results First Posted: 2023-01-19
• Last Update Posted: 2023-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mobile After-Care Support (MACS) app	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.

Primary Outcome Measures

Name	Time	Method
Client Satisfaction Questionnaire (CSQ)	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.

Secondary Outcome Measures

Name	Time	Method
Brief Adherence Rating Scale (BARS)	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.
Brief Psychiatric Rating Scale (BPRS)	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.
Maastricht Assessment of Coping Strategies (MACS)	1 month	The MACS is an interviewer-rated assessment of the coping strategies that patients report using to manage their symptoms.

Trial Locations

Locations (1)

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States