Improving Detection and Evidence-based Care of NAFLD in Latinx and Black Patients With Type 2 Diabetes

Not Applicable

Completed

Conditions: NAFLD
Diabetes Mellitus

Interventions: Behavioral: NAFLD Education
Behavioral: diet/lifestyle support
Drug: T2D medication management
Diagnostic Test: clinically-indicated liver testing and care

Registration Number: NCT05844137

Lead Sponsor: Duke University

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 10

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Evidence-based care of NAFLD in T2D	NAFLD Education	Intervention content will include: 1) NAFLD education; 2) diet/lifestyle support; 3) T2D medication management; and 4) clinically-indicated liver testing and care
Evidence-based care of NAFLD in T2D	diet/lifestyle support	Intervention content will include: 1) NAFLD education; 2) diet/lifestyle support; 3) T2D medication management; and 4) clinically-indicated liver testing and care
Evidence-based care of NAFLD in T2D	T2D medication management	Intervention content will include: 1) NAFLD education; 2) diet/lifestyle support; 3) T2D medication management; and 4) clinically-indicated liver testing and care
Evidence-based care of NAFLD in T2D	clinically-indicated liver testing and care	Intervention content will include: 1) NAFLD education; 2) diet/lifestyle support; 3) T2D medication management; and 4) clinically-indicated liver testing and care

Primary Outcome Measures

Name	Time	Method
Feasibility as Measured by Recruitment Rate	3 months	The Investigator will assess recruitment rates: Patients eligible and sent letter of message / Patients enrolled
Feasibility as Measured by Retention Rate	3months	The team will assess retention rates: Patients enrolled / Patients completing study
Feasibility as Measured by Visit Completion Rate	3months	The Investigator assess visit completion rates: Total study visits completed / Total study visits scheduled
Feasibility of System-level NAFLD Detection Approach	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	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 Outcome Measures

Name	Time	Method
Change in Self-Efficacy Measured by the Managing Chronic Diseases (SEMCD) Score	Baseline, 3months	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.
Change in Autonomy Support Measured by the Modified Health Care Climate Questionnaire (HCCQ)	Baseline, 3months	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.
Change in Physical Health Quality of Living as Measured by the 12-Item Short Form Health Survey (SF-12)	Baseline, 3months	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.
Change in Mental Health Quality of Living as Measured by the SF-12	Baseline, 3months	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.
Change in Mean Hemoglobin A1c (HbA1c)	Baseline, 3months	Change of \>/= 0.5% will be deemed clinically significant
Change in Mean Alanine Aminotransferase (ALT) Level	Baseline, 3months	Change of \>/= 5 IU/mL will be deemed clinically significant.
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