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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The purpose of this study is to to culturally tailor a technology-based individualized adherence intervention for Black and Latino patients with uncontrolled HTN or T2DM, who are non-adherent to their medications, and determine its acceptability.
Using a randomized controlled trial design, this study will compare the efficacy of a tailored adherence intervention (TAI) to a single patient education (PE) session, on medication adherence among 40 high-risk Black and Latino patients with uncontrolled hypertension (HTN) who are non-adherent to their prescribed antihypertensive medications. Patients randomized to the PE group will receive a single tablet delivered patient education session at the baseline visit. Patients randomized to the TAI group will complete a tailoring survey at the baseline visit to identify the most salient adherence barriers to the individual, which will be used to create an individualized adherence profile. Following completion of the tailoring survey, patients will collaborate with the RA to identify the most suitable mix of intervention strategies for improving medication adherence (i.e., reminder aids, motivational interviewing, case management) that are matched to the barriers outlined on patients' individualized adherence profiles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Attention Control | Active Comparator | Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes |
|
| Tailored Adherence Intervention | Experimental | Tablet-based tailored adherence intervention matched to patients' most salient adherence barriers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adherence Intervention | Behavioral | Patients randomized to the TAI group will complete a tailoring survey at the baseline visit to identify the most salient adherence barriers to the individual, which will be used to create an individualized adherence profile. Following completion of the tailoring survey, patients will collaborate with the RA to identify the most suitable mix of intervention strategies for improving medication adherence (i.e., reminder aids, motivational interviewing, case management) that are matched to the barriers outlined on patients' individualized adherence profiles. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Retaining Study Participants Through the 3 Month Trial | Feasibility is assessed as the absolute number of patients that are retained in the study once they are consented and enrolled at baseline. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Systolic and Diastolic Blood Pressure at 3 Months | Change in mean systolic and diastolic blood pressure readings from baseline to 3 months. Systolic and diastolic blood pressure are measured in mmHg using a validated automated blood pressure monitor. The average of three readings was used as the blood pressure measurements for the baseline and 3 month study visit. | baseline and 3 months |
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Inclusion Criteria:
Exclusion Criteria:
Vulnerable populations including adults unable to provide informed consent, pregnant women, and prisoners will be excluded from this study.
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| Name | Affiliation | Role |
|---|---|---|
| Antoinette Schoenthaler, EdD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Health Center | New York | New York | 10001 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32965230 | Derived | Schoenthaler A, Leon M, Butler M, Steinhaeuser K, Wardzinski W. Development and Evaluation of a Tailored Mobile Health Intervention to Improve Medication Adherence in Black Patients With Uncontrolled Hypertension and Type 2 Diabetes: Pilot Randomized Feasibility Trial. JMIR Mhealth Uhealth. 2020 Sep 23;8(9):e17135. doi: 10.2196/17135. | |
| 26134837 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Attention Control | Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes Attention Control: Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes |
| FG001 | Tailored Adherence Intervention | Tablet-based tailored adherence intervention matched to patients' most salient adherence barriers Adherence Intervention: Patients randomized to the TAI group will complete a tailoring survey at the baseline visit to identify the most salient adherence barriers to the individual, which will be used to create an individualized adherence profile. Following completion of the tailoring survey, patients will collaborate with the RA to identify the most suitable mix of intervention strategies for improving medication adherence (i.e., reminder aids, motivational interviewing, case management) that are matched to the barriers outlined on patients' individualized adherence profiles. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Attention Control | Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes Attention Control: Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes |
| BG001 | Tailored Adherence Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Feasibility of Retaining Study Participants Through the 3 Month Trial | Feasibility is assessed as the absolute number of patients that are retained in the study once they are consented and enrolled at baseline. | The number of participants that were retained in the study from baseline to 3 months. | Posted | Count of Participants | Participants | 3 months |
|
3 months
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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 | Attention Control | Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes Attention Control: Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Antoinette Schoenthaler | NYU School of Medicine | 212-263-4205 | antoinette.schoenthaler@nyumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 2, 2016 | May 10, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 10, 2018 | Aug 2, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
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|
| Attention Control | Other | Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes |
|
| Change From Baseline in HbA1c at 3 Months | Change in HbA1c from baseline to 3 months using a validated point-of-care device (Afinion AS100 Analyzer) at baseline and 3 months. | baseline and 3 months |
| Change From Baseline in Self-reported Medication Adherence at 3 Months | Medication adherence will be assessed by self-report using the validated 8-item Morisky Medication Adherence Scale. Scores range from 0-8, with higher scores indicative of better medication adherence. | Baseline and 3 months |
| Schoenthaler A, De La Calle F, Barrios-Barrios M, Garcia A, Pitaro M, Lum A, Rosal M. A practice-based randomized controlled trial to improve medication adherence among Latinos with hypertension: study protocol for a randomized controlled trial. Trials. 2015 Jul 2;16:290. doi: 10.1186/s13063-015-0815-x. |
Tablet-based tailored adherence intervention matched to patients' most salient adherence barriers Adherence Intervention: Patients randomized to the TAI group will complete a tailoring survey at the baseline visit to identify the most salient adherence barriers to the individual, which will be used to create an individualized adherence profile. Following completion of the tailoring survey, patients will collaborate with the RA to identify the most suitable mix of intervention strategies for improving medication adherence (i.e., reminder aids, motivational interviewing, case management) that are matched to the barriers outlined on patients' individualized adherence profiles. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Educational Status | Count of Participants | Participants |
|
| Unemployed | Count of Participants | Participants |
|
| Annual income less than $40,000 | Count of Participants | Participants |
|
Tablet-based tailored adherence intervention matched to patients' most salient adherence barriers
Adherence Intervention: Patients randomized to the TAI group will complete a tailoring survey at the baseline visit to identify the most salient adherence barriers to the individual, which will be used to create an individualized adherence profile. Following completion of the tailoring survey, patients will collaborate with the RA to identify the most suitable mix of intervention strategies for improving medication adherence (i.e., reminder aids, motivational interviewing, case management) that are matched to the barriers outlined on patients' individualized adherence profiles.
|
|
| Secondary | Change From Baseline in Mean Systolic and Diastolic Blood Pressure at 3 Months | Change in mean systolic and diastolic blood pressure readings from baseline to 3 months. Systolic and diastolic blood pressure are measured in mmHg using a validated automated blood pressure monitor. The average of three readings was used as the blood pressure measurements for the baseline and 3 month study visit. | Posted | Mean | Standard Error | mmHg | baseline and 3 months |
|
|
|
| Secondary | Change From Baseline in HbA1c at 3 Months | Change in HbA1c from baseline to 3 months using a validated point-of-care device (Afinion AS100 Analyzer) at baseline and 3 months. | Posted | Mean | Standard Error | percentage of A1c | baseline and 3 months |
|
|
|
| Secondary | Change From Baseline in Self-reported Medication Adherence at 3 Months | Medication adherence will be assessed by self-report using the validated 8-item Morisky Medication Adherence Scale. Scores range from 0-8, with higher scores indicative of better medication adherence. | Posted | Mean | Standard Error | score on a scale | Baseline and 3 months |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Tailored Adherence Intervention | Tablet-based tailored adherence intervention matched to patients' most salient adherence barriers Adherence Intervention: Patients randomized to the TAI group will complete a tailoring survey at the baseline visit to identify the most salient adherence barriers to the individual, which will be used to create an individualized adherence profile. Following completion of the tailoring survey, patients will collaborate with the RA to identify the most suitable mix of intervention strategies for improving medication adherence (i.e., reminder aids, motivational interviewing, case management) that are matched to the barriers outlined on patients' individualized adherence profiles. | 0 | 21 | 0 | 21 | 0 | 21 |
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| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |