Improving Detection and Evidence-based Care of NAFLD in Latinx and Black Patients With Type 2 Diabetes (NAFLD-DM): A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Feasibility as Measured by Recruitment Rate
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •People who identify as either: Latino/Latina/Hispanic ethnicity and/or Black or African American race
- •People with type 2 diabetes (T2D), as defined by ICD-10 codes E11.xx.
- •Patients with elevated serum alanine aminotransferase (ALT) within Duke University Healthcare System (DUHS). Elevated ALT will be defined as having at least two ALT ≥40 IU/mL in males or ≥31 IU/mL in females in the preceding 12 months
Exclusion Criteria
- •People with hepatitis B or C infection
- •People with known alcohol overuse
- •People with current use of chemotherapy or other drugs known to affect liver function
- •People who have not been seen by a DUHS Primary Care Physician (PCP) or Endocrinologist in the preceding year.
Arms & Interventions
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
Intervention: NAFLD Education (Behavioral)
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
Intervention: diet/lifestyle support (Behavioral)
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
Intervention: T2D medication management (Drug)
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
Intervention: clinically-indicated liver testing and care (Diagnostic Test)
Outcomes
Primary Outcomes
Feasibility as Measured by Recruitment Rate
Time Frame: 3 months
The Investigator will assess recruitment rates: Patients eligible and sent letter of message / Patients enrolled
Feasibility as Measured by Retention Rate
Time Frame: 3months
The team will assess retention rates: Patients enrolled / Patients completing study
Feasibility as Measured by Visit Completion Rate
Time Frame: 3months
The Investigator assess visit completion rates: Total study visits completed / Total study visits scheduled
Feasibility of System-level NAFLD Detection Approach
Time Frame: Baseline
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.
Acceptability of Intervention by Participants
Time Frame: 3months
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.
Secondary Outcomes
- Change in Self-Efficacy Measured by the Managing Chronic Diseases (SEMCD) Score(Baseline, 3months)
- Change in Autonomy Support Measured by the Modified Health Care Climate Questionnaire (HCCQ)(Baseline, 3months)
- Change in Physical Health Quality of Living as Measured by the 12-Item Short Form Health Survey (SF-12)(Baseline, 3months)
- Change in Mental Health Quality of Living as Measured by the SF-12(Baseline, 3months)
- Change in Mean Hemoglobin A1c (HbA1c)(Baseline, 3months)
- Change in Mean Alanine Aminotransferase (ALT) Level(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)