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The primary objective of this pilot study is to assess the feasibility and acceptability of an intervention for improved detection and evidence-based care of NAFLD in Latinx and Black patients with type 2 diabetes (T2D) in Duke University Healthcare system (DUHS). We will enroll 10-15 Latinx and 10-15 Black patients with T2D and NAFLD, based on having mildly elevated liver enzymes (ALT >/= 40 IU/mL in males, ALT >/= 31 IU/mL in females) and exclusion of other liver diseases (e.g., viral hepatitis, alcohol abuse).
Intervention content will include: 1) NAFLD education; 2)diet/lifestyle support; 3) T2D medication management; and 4) clinically-indicated liver testing and care.
Intervention feasibility will be evaluated by examining recruitment rates, retention rates, and study visit completion rates. Acceptability will be assessed by survey and through qualitative interviews. The project objectives and intervention are minimal risk. The expected risks will not exceed those of usual care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evidence-based care of NAFLD in T2D | Experimental | Intervention content will include: 1) NAFLD education; 2) diet/lifestyle support; 3) T2D medication management; and 4) clinically-indicated liver testing and care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NAFLD Education | Behavioral | NAFLD Education |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility as Measured by Recruitment Rate | The Investigator will assess recruitment rates: Patients eligible and sent letter of message / Patients enrolled | 3 months |
| Feasibility as Measured by Retention Rate | The team will assess retention rates: Patients enrolled / Patients completing study | 3months |
| Feasibility as Measured by Visit Completion Rate | The Investigator assess visit completion rates: Total study visits completed / Total study visits scheduled | 3months |
| Feasibility of System-level NAFLD Detection Approach | Measure by the number of patients who met criteria for NAFLD after chart review / total number of potentially-eligible patients based on our EHR criteria. | Baseline |
| Acceptability of Intervention by Participants | The Investigator will calculate the mean and standard deviation of the Treatment Acceptability and Preferences (TAP);Minimum value = 0; Maximum value = 4; Higher score is a better outcome (ie more acceptable). The Investigator define acceptable score as mean TAP ≥ 3. | 3months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-Efficacy Measured by the Managing Chronic Diseases (SEMCD) Score | The SEMCD is a 6-item scale with a total minimum value = 1; a total maximum value = 10; Higher score is a better outcome (ie greater self-efficacy). Will be measured by a change of >/=1. | Baseline, 3months |
| Change in Autonomy Support Measured by the Modified Health Care Climate Questionnaire (HCCQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anastasia-Stefania Alexopoulos, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Healthcare System | Durham | North Carolina | 27710 | United States |
NA- IPD will not be made available to other researchers
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| ID | Title | Description |
|---|---|---|
| FG000 | Evidence-based Care of NAFLD in T2D | Intervention content will include: 1) NAFLD education; 2) diet/lifestyle support; 3) T2D medication management; and 4) clinically-indicated liver testing and care NAFLD Education: NAFLD Education diet/lifestyle support: diet/lifestyle support T2D medication management: T2D medication management clinically-indicated liver testing and care: clinically-indicated liver testing and care |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | May 31, 2024 | Sep 11, 2024 |
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| diet/lifestyle support |
| Behavioral |
diet/lifestyle support |
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| T2D medication management | Drug | T2D medication management |
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| clinically-indicated liver testing and care | Diagnostic Test | clinically-indicated liver testing and care |
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The HCCQ is a 5-item scale with a total minimum value = 1; a total maximum value = 5; Higher score is a better outcome (ie greater self-management) Will be measured by a change of >/=1 as being clinically significant. |
| Baseline, 3months |
| Change in Physical Health Quality of Living as Measured by the 12-Item Short Form Health Survey (SF-12) | The SF-12 is a 5-item scale with a total minimum value = 0; a total maximum value = 100; Higher score is a better outcome (ie greater quality of life) Will be measured by a change of >/=10 as being clinically significant. | Baseline, 3months |
| Change in Mental Health Quality of Living as Measured by the SF-12 | The SF-12 is a 5-item scale with a total minimum value = 0; a total maximum value = 100; Higher score is a better outcome (ie greater quality of life) Will be measured by a change of >/=10 as being clinically significant. | Baseline, 3months |
| Change in Mean Hemoglobin A1c (HbA1c) | Change of >/= 0.5% will be deemed clinically significant | Baseline, 3months |
| Change in Mean Alanine Aminotransferase (ALT) Level | Change of >/= 5 IU/mL will be deemed clinically significant. | Baseline, 3months |
| Number of Participants With Changes to Medications During the Study Period Measured by Chart Review | baseline, 3 months |
| Number of Participants in Whom Clinically-indicated Tests Were Ordered (e.g. Labs, Referral, Imaging). | baseline, 3 months |
| COMPLETED |
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| NOT COMPLETED |
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There were fewer participants than initially anticipated due to budget/resource constraints
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| ID | Title | Description |
|---|---|---|
| BG000 | Evidence-based Care of NAFLD in T2D | Intervention content will include: 1) NAFLD education; 2) diet/lifestyle support; 3) T2D medication management; and 4) clinically-indicated liver testing and care NAFLD Education: NAFLD Education diet/lifestyle support: diet/lifestyle support T2D medication management: T2D medication management clinically-indicated liver testing and care: clinically-indicated liver testing and care |
| 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 | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Number | participants |
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| Non-adherence to diabetes medications | 9 participants were on non-insulin medications and only 1 participant was on insulin. | Count of Participants | Participants |
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| 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 as Measured by Recruitment Rate | The Investigator will assess recruitment rates: Patients eligible and sent letter of message / Patients enrolled | This outcome includes all patients that were approached for recruitment either by cold call or MyChart messages. | Posted | Count of Participants | Participants | 3 months |
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| Primary | Feasibility as Measured by Retention Rate | The team will assess retention rates: Patients enrolled / Patients completing study | Posted | Count of Participants | Participants | 3months |
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| Primary | Feasibility as Measured by Visit Completion Rate | The Investigator assess visit completion rates: Total study visits completed / Total study visits scheduled | There were 3 study visits per participant so 30 total study visits. | Posted | Number | number of study visits | 3months | Number of Visits Scheduled | Number of Visits Scheduled |
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| Primary | Feasibility of System-level NAFLD Detection Approach | Measure by the number of patients who met criteria for NAFLD after chart review / total number of potentially-eligible patients based on our EHR criteria. | This outcome includes potentially eligible participants identified prior to enrollment. The charts of 184 patients were reviewed and 122 patients were ultimately found to be eligible. | Posted | Number | patient charts reviewed | Baseline |
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| Primary | Acceptability of Intervention by Participants | The Investigator will calculate the mean and standard deviation of the Treatment Acceptability and Preferences (TAP);Minimum value = 0; Maximum value = 4; Higher score is a better outcome (ie more acceptable). The Investigator define acceptable score as mean TAP ≥ 3. | Posted | Mean | Standard Deviation | score on a scale | 3months |
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| Secondary | Change in Self-Efficacy Measured by the Managing Chronic Diseases (SEMCD) Score | The SEMCD is a 6-item scale with a total minimum value = 1; a total maximum value = 10; Higher score is a better outcome (ie greater self-efficacy). Will be measured by a change of >/=1. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3months |
|
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| Secondary | Change in Autonomy Support Measured by the Modified Health Care Climate Questionnaire (HCCQ) | The HCCQ is a 5-item scale with a total minimum value = 1; a total maximum value = 5; Higher score is a better outcome (ie greater self-management) Will be measured by a change of >/=1 as being clinically significant. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3months |
|
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| Secondary | Change in Physical Health Quality of Living as Measured by the 12-Item Short Form Health Survey (SF-12) | The SF-12 is a 5-item scale with a total minimum value = 0; a total maximum value = 100; Higher score is a better outcome (ie greater quality of life) Will be measured by a change of >/=10 as being clinically significant. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3months |
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Mental Health Quality of Living as Measured by the SF-12 | The SF-12 is a 5-item scale with a total minimum value = 0; a total maximum value = 100; Higher score is a better outcome (ie greater quality of life) Will be measured by a change of >/=10 as being clinically significant. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3months |
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| Secondary | Change in Mean Hemoglobin A1c (HbA1c) | Change of >/= 0.5% will be deemed clinically significant | Due to budget constraints, data were not collected. | Posted | Baseline, 3months |
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| Secondary | Change in Mean Alanine Aminotransferase (ALT) Level | Change of >/= 5 IU/mL will be deemed clinically significant. | Due to budget constraints, data were not collected. | Posted | Baseline, 3months |
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| Secondary | Number of Participants With Changes to Medications During the Study Period Measured by Chart Review | Posted | Count of Participants | Participants | baseline, 3 months |
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| Secondary | Number of Participants in Whom Clinically-indicated Tests Were Ordered (e.g. Labs, Referral, Imaging). | Posted | Count of Participants | Participants | baseline, 3 months |
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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 | Evidence-based Care of NAFLD in T2D | Intervention content will include: 1) NAFLD education; 2) diet/lifestyle support; 3) T2D medication management; and 4) clinically-indicated liver testing and care NAFLD Education: NAFLD Education diet/lifestyle support: diet/lifestyle support T2D medication management: T2D medication management clinically-indicated liver testing and care: clinically-indicated liver testing and care | 0 | 10 | 0 | 10 | 0 | 10 |
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Due to resources constraints, we did not achieve our target number of participants. We did not conduct effect size calculations or inferential statistics due to the small sample size and pilot nature of this study. Further, larger studies will be necessary to examine the effectiveness of this approach - across broader racial and ethnic identities - and to determine the effectiveness of this intervention (versus usual care) on clinically-relevant outcomes.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anastasia Alexopoulos | Duke University | 1 919 684 4005 | anastasia.alexopoulos@duke.edu |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 31, 2024 | Sep 11, 2024 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 18, 2023 | Dec 5, 2023 | ICF_000.pdf |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Insulin |
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| Number of Visits Scheduled |
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