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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH115144 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Brief Adherence Rating Scale (BARS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brandon A Gaudiano, Ph.D. | Butler Hospital & Brown Universit | Principal Investigator |
| Ethan Moitra, Ph.D. | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Butler Hospital | Providence | Rhode Island | 02906 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32613525 | Result | 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. |
| Label | URL |
|---|---|
| Development and initial testing of an mHealth transitions of care intervention for adults with schizophrenia-spectrum disorders immediately following a psychiatric hospitalization | View source |
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Data available on the National Institute of Mental Health Data Archive (NDA).
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Currently available.
See NDA web site for details.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 1 month |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rehospitalization | Psychiatric disorders | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ethan Moitra, Ph.D. | Brown University | 4014441949 | ethan_moitra@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 15, 2019 | Dec 6, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D055118 | Medication Adherence |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
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| ID | Term |
|---|---|
| D000682 | Amyloid |
| ID | Term |
|---|---|
| D046912 | Multiprotein Complexes |
| D046911 | Macromolecular Substances |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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An uncontrolled open trial approach will be used in which all participants receive the MACS app.
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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 |
| 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 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 1 month |
|
|
|
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| 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. | No data were collected for this measure (MACS). This is because we were unable to administer the measure as originally planned. | Posted | 1 month |
|
|
| 0 |
| 10 |
| 1 |
| 10 |
| 0 |
| 10 |
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| D015438 | Health Behavior |
| D001519 | Behavior |