Trial Outcomes & Findings for Improving Detection and Evidence-based Care of NAFLD in Latinx and Black Patients With Type 2 Diabetes (NCT NCT05844137)

Results Overview

The Investigator will assess recruitment rates: Patients eligible and sent letter of message / Patients enrolled

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

3 months

Results posted on

2024-12-27

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

9 participants were on non-insulin medications and only 1 participant was on insulin.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Evidence-based Care of NAFLD in T2D n=10 Participants 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
Age, Continuous	51.1 years STANDARD_DEVIATION 9.6 • n=10 Participants
Sex: Female, Male Female	5 Participants n=10 Participants
Sex: Female, Male Male	5 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=10 Participants
Race (NIH/OMB) Asian	1 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	4 Participants n=10 Participants
Race (NIH/OMB) White	3 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=10 Participants
Region of Enrollment United States	10 participants n=10 Participants
Non-adherence to diabetes medications Non-insulin medications	2 Participants n=9 Participants • 9 participants were on non-insulin medications and only 1 participant was on insulin.
Non-adherence to diabetes medications Insulin	1 Participants n=1 Participants • 9 participants were on non-insulin medications and only 1 participant was on insulin.

PRIMARY outcome

Timeframe: 3 months

Population: This outcome includes all patients that were approached for recruitment either by cold call or MyChart messages.

The Investigator will assess recruitment rates: Patients eligible and sent letter of message / Patients enrolled

Outcome measures

Outcome measures
Measure	Evidence-based Care of NAFLD in T2D n=51 Participants 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
Feasibility as Measured by Recruitment Rate Recruitment by Cold Call	8 Participants
Feasibility as Measured by Recruitment Rate Recruitment by MyChart	2 Participants

PRIMARY outcome

Timeframe: 3months

The team will assess retention rates: Patients enrolled / Patients completing study

Outcome measures

Outcome measures
Measure	Evidence-based Care of NAFLD in T2D n=10 Participants 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
Feasibility as Measured by Retention Rate	10 Participants

PRIMARY outcome

Timeframe: 3months

Population: There were 3 study visits per participant so 30 total study visits.

The Investigator assess visit completion rates: Total study visits completed / Total study visits scheduled

Outcome measures

Outcome measures
Measure	Evidence-based Care of NAFLD in T2D n=30 Number of Visits Scheduled 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
Feasibility as Measured by Visit Completion Rate	30 number of study visits

PRIMARY outcome

Timeframe: Baseline

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Evidence-based Care of NAFLD in T2D n=184 Participants 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
Feasibility of System-level NAFLD Detection Approach	122 patient charts reviewed

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Evidence-based Care of NAFLD in T2D n=10 Participants 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
Acceptability of Intervention by Participants	3.98 score on a scale Standard Deviation 0.13

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Evidence-based Care of NAFLD in T2D n=10 Participants 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
Change in Self-Efficacy Measured by the Managing Chronic Diseases (SEMCD) Score	0.4 score on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Evidence-based Care of NAFLD in T2D n=10 Participants 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
Change in Autonomy Support Measured by the Modified Health Care Climate Questionnaire (HCCQ)	-0.1 score on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Evidence-based Care of NAFLD in T2D n=10 Participants 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
Change in Physical Health Quality of Living as Measured by the 12-Item Short Form Health Survey (SF-12)	3.0 score on a scale Standard Deviation 3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Evidence-based Care of NAFLD in T2D n=10 Participants 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
Change in Mental Health Quality of Living as Measured by the SF-12	0.5 score on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: Baseline, 3months

Population: Due to budget constraints, data were not collected.

Change of \>/= 0.5% will be deemed clinically significant

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 3months

Population: Due to budget constraints, data were not collected.

Change of \>/= 5 IU/mL will be deemed clinically significant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline, 3 months

Outcome measures

Outcome measures
Measure	Evidence-based Care of NAFLD in T2D n=10 Participants 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
Number of Participants With Changes to Medications During the Study Period Measured by Chart Review	5 Participants

SECONDARY outcome

Timeframe: baseline, 3 months

Outcome measures

Outcome measures
Measure	Evidence-based Care of NAFLD in T2D n=10 Participants 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
Number of Participants in Whom Clinically-indicated Tests Were Ordered (e.g. Labs, Referral, Imaging). Labs Ordered	7 Participants
Number of Participants in Whom Clinically-indicated Tests Were Ordered (e.g. Labs, Referral, Imaging). Imaging Ordered	2 Participants
Number of Participants in Whom Clinically-indicated Tests Were Ordered (e.g. Labs, Referral, Imaging). Hepatology referral placed	1 Participants

Adverse Events

Evidence-based Care of NAFLD in T2D

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anastasia Alexopoulos

Duke University

Phone: 1 919 684 4005

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place