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Completed

NCT Number: NCT03769493

Mobile After-Care Intervention to Support Post-Hospital Transition (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.

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Key information

Conditions

Psychotic Disorders Behavior Health Behavior Medication Adherence Mental Disorders Patient Acceptance of Health Care Patient Compliance Schizophrenia Spectrum and Other Psychotic Disorders Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: MACS

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 7, 2018
Registry last updated
Jan 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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