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

NCT03769493 | Completed Results DMC

• 2 other identifiers: 1806-001R34MH115144
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychotic Disorders

Keywords

Medication adherence; Treatment adherence; Ecological momentary assessment; Ecological momentary intervention; Coping skills; Psychiatric Hospitalization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Brief Psychiatric Rating Scale (BPRS)

  1 month

• Brief Adherence Rating Scale (BARS)

  1 month

• Maastricht Assessment of Coping Strategies (MACS)

  1 month

Study Arms (1)

Mobile After-Care Support (MACS) app

EXPERIMENTAL

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

Interventions

Mobile After-Care Support (MACS) app 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.

Mobile After-Care Support (MACS) app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Butler Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Related 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: 10.1007/s11126-020-09792-9.

  PMID: 32613525 RESULT

Related Links

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

MeSH Terms

Conditions

Psychotic Disorders; Medication Adherence; Treatment Adherence and Compliance

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Patient Compliance; Patient Acceptance of Health Care; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Limitations and Caveats

This is a treatment development study and therefore was not designed to test the efficacy of the intervention given the small sample size. Instead, the goal was examine feasibility and acceptability.

Results Point of Contact

• Title: Ethan Moitra, Ph.D.
• Organization: Brown University

ethan_moitra@brown.edu

4014441949

Study Officials

• Brandon A Gaudiano, Ph.D.

  Butler Hospital & Brown Universit

  PRINCIPAL INVESTIGATOR

• Ethan Moitra, Ph.D.

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychologist

Model Details: An uncontrolled open trial approach will be used in which all participants receive the MACS app.

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 7, 2018
• Study Start: January 16, 2019
• Primary Completion: October 15, 2019
• Study Completion: October 15, 2019
• Last Updated: January 19, 2023
• Results First Posted: January 19, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Currently available.
• Access Criteria: See NDA web site for details.

Locations

US (1)