Mobile After-Care Intervention to Support Post-Hospital Transition (MACS) (MACS)
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|ClinicalTrials.gov Identifier: NCT03769493|
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : January 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Psychotic Disorders||Behavioral: Mobile After-Care Support (MACS) app||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||An uncontrolled open trial approach will be used in which all participants receive the MACS app.|
|Masking:||None (Open Label)|
|Official Title:||Mobile After-Care Support Intervention for Patients With Schizophrenia Following Hospitalization (MACS)|
|Actual Study Start Date :||January 16, 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||April 2021|
Experimental: 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.
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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769493
|Contact: Brandon A Gaudiano, Ph.D.||(401) email@example.com|
|Contact: Hyun Seon Park||(401) firstname.lastname@example.org|
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02906|
|Contact: Cheryl Cordeiro 401-455-6654 email@example.com|
|Principal Investigator: Brandon A Gaudiano, Ph.D.|
|Principal Investigator:||Brandon A Gaudiano, Ph.D.||Butler Hospital & Brown Universit|
|Principal Investigator:||Ethan Moitra, Ph.D.||Brown University|