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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23AA032563-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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This study seeks to develop and test a novel digital pill system (DPS) that measures real-time medication ingestion and pairs it with a cognitive behavioral therapy (CBT)-based intervention to provide personalized, data-driven adherence support, with the long-term goal of providing new and improved personalized support and increase medication adherence for people with AUD and ALD.
The primary objective is to develop and examine the feasibility and acceptability of AcamproSync, an adherence intervention that combines a digital pill system (DPS) technology with personalized adherence feedback and support.
This intervention aims to improve acamprosate adherence in patients with alcohol use disorder and alcohol-associated liver disease. A pilot randomized control trial of AcamproSync compared to treatment as usual will be conducted to assess the feasibility and acceptability of the adherence intervention paired with DPS (AcamproSync). Secondarily, change in adherence, number of days drinking, and number of days abstinent will be explored. The study will take place at Yale New Haven Hospital, among people with alcohol use disorder and alcohol-associated liver disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AcamproSync | Experimental | Participants will 1.) use the AcamproSync system which directly measures acamprosate adherence, 2) receive a personalized, adherence intervention grounded in the empiric LifeSteps Cognitive Behavioral Therapy framework and 3) self-management and introspection into alcohol use patterns through ecological momentary assessments (EMA) of drinking and alcohol craving. |
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| Control (Treatment as Usual) | No Intervention | Participants will receive treatment as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcamproSync | Device | AcamproSync, is an innovative behavioral intervention to support acamprosate adherence in individuals with ALD. It comprises three components: 1) a digital pill system that directly measures acamprosate adherence, 2) a personalized, adherence intervention grounded in the empiric LifeSteps Cognitive Behavioral Therapy framework and 3) self-management and introspection into alcohol use patterns through ecological momentary assessments (EMA) of drinking and alcohol craving. |
| Measure | Description | Time Frame |
|---|---|---|
| Ability to enroll participants- Feasibility | Number of participants enrolled out of all screened. | Baseline and 30 days |
| Retention- Feasibility | Number of participants enrolled that complete the 30 day follow-up. | Baseline and 30 days |
| Feasibility of Intervention Measure (FIM)- Feasibility | Feasibility of intervention measured using Feasibility of Intervention Measure (FIM)- a 4-item instrument to assess perceived intervention feasibility. Total score 1-5 with higher scores indicating greater feasibility. | Baseline and 30 days |
| Acceptability of Intervention (AIM)- Acceptability | Treatment Acceptability will be measured using the Acceptability of Intervention Measure (AIM), a 4-item measure of perceived intervention acceptability. Total score 1-5 with higher scores indicating greater acceptability. | Baseline and 30 days |
| Mean score Post-Study System Usability Questionnaire (PSSUQ)- Acceptability | PSSUQ a 16-item standardized questionnaire. Total scores ranging from 1 to 7, where lower scores indicate better user satisfaction and usability. | Baseline and 30 days |
| Mean score Health Information Technology Usability Evaluation Scale (Health-ITUES) - Acceptability | Health-ITUES is a 20-item scale that measures technology usability. Total score range 1-5 with higher scores indicating better usability | Baseline and 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| DPS Accuracy | Correlation coefficient between DPS recorded adherence and pill counts. | Baseline and 30 days |
| Heavy drinking frequency | Mean days heavy drinking in the last thirty days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charlotte Goldfine, MD | Contact | 203-785-2353 | charlotte.goldfine@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Charlotte Goldfine | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale | New Haven | Connecticut | 06520 | United States |
Raw data will be de-identified by removing protected identifiers. This will be clearly explained to participants as part of the human subjects consent process. The data generated through this project will be deposited into Yale Dataverse data repository and the NIAAA Data Archive (NIAAADA). Yale Dataverse is an open-access, online data repository available to investigators at Yale University. The NIAAADA a data repository hosted and managed by the National Institute of Mental Health (NIMH) Data Archive (NDA) for de-identified individual-level data that can be made available to the general research community.
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Participants with alcohol use disorder and alcohol-associated liver disease
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| Mean System Usability Scale (SUS) score- Usability |
SUS is a reliable, 10-item questionnaire used to measure the subjective usability of products, websites, or software, producing a score from 0 to 100. Higher scores indicate more usability. |
| Baseline and 30 days |
| Baseline and 30 days |
| Abstinence frequency | Mean days drinking abstinence in the last thirty days | Baseline and 30 days |
| Linkage to AUD treatment | Binary yes/no indicating if an individual was linked to further treatment post-inpatient treatment | Baseline and 30 days |
| Mean score Alcohol Craving Questionnaire Short Form Revised (ACQ-SF-R) | Mean score from 1 to 7 with higher scores indicating more severe alcohol craving. | Baseline and 30 days |
| Acamprosate adherence by self report | Self report pill counts at the 30 day visit | Day 30 |
| DPS Acamprosate adherence | DPS report pill counts at the 30 day visit | Day 30 |
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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