Diabetes Mellitus, NAFLD
Conditions
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.
Interventions
BEHAVIORALNAFLD Education
NAFLD Education
BEHAVIORALdiet/lifestyle support
diet/lifestyle support
DRUGT2D medication management
T2D medication management
DIAGNOSTIC_TESTclinically-indicated liver testing and care
clinically-indicated liver testing and care
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Alanine Aminotransferase (ALT) Level | Baseline, 3months | Change of \>/= 5 IU/mL will be deemed clinically significant. |
| 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. |
| Number of Participants in Whom Clinically-indicated Tests Were Ordered (e.g. Labs, Referral, Imaging). | baseline, 3 months | — |
| Number of Participants With Changes to Medications During the Study Period Measured by Chart Review | baseline, 3 months | — |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Evidence-based Care of NAFLD in T2D |
|---|---|
| Age, Continuous | 51.1 years STANDARD_DEVIATION 9.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Non-adherence to diabetes medications Insulin | 1 Participants |
| Non-adherence to diabetes medications Non-insulin medications | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
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.
Time frame: 3months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Evidence-based Care of NAFLD in T2D | Acceptability of Intervention by Participants | 3.98 score on a scale | Standard Deviation 0.13 |
Primary
Feasibility as Measured by Recruitment Rate
The Investigator will assess recruitment rates: Patients eligible and sent letter of message / Patients enrolled
Time frame: 3 months
Population: This outcome includes all patients that were approached for recruitment either by cold call or MyChart messages.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Evidence-based Care of NAFLD in T2D | Feasibility as Measured by Recruitment Rate | Recruitment by Cold Call | 8 Participants |
| Evidence-based Care of NAFLD in T2D | Feasibility as Measured by Recruitment Rate | Recruitment by MyChart | 2 Participants |
Primary
Feasibility as Measured by Retention Rate
The team will assess retention rates: Patients enrolled / Patients completing study
Time frame: 3months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Evidence-based Care of NAFLD in T2D | Feasibility as Measured by Retention Rate | 10 Participants |
Primary
Feasibility as Measured by Visit Completion Rate
The Investigator assess visit completion rates: Total study visits completed / Total study visits scheduled
Time frame: 3months
Population: There were 3 study visits per participant so 30 total study visits.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Evidence-based Care of NAFLD in T2D | Feasibility as Measured by Visit Completion Rate | 30 number of study visits |
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Evidence-based Care of NAFLD in T2D | Feasibility of System-level NAFLD Detection Approach | 122 patient charts reviewed |
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.
Time frame: Baseline, 3months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Evidence-based Care of NAFLD in T2D | Change in Autonomy Support Measured by the Modified Health Care Climate Questionnaire (HCCQ) | -0.1 score on a scale | Standard Deviation 0.7 |
Secondary
Change in Mean Alanine Aminotransferase (ALT) Level
Change of \>/= 5 IU/mL will be deemed clinically significant.
Time frame: Baseline, 3months
Population: Due to budget constraints, data were not collected.
Secondary
Change in Mean Hemoglobin A1c (HbA1c)
Change of \>/= 0.5% will be deemed clinically significant
Time frame: Baseline, 3months
Population: Due to budget constraints, data were not collected.
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.
Time frame: Baseline, 3months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Evidence-based Care of NAFLD in T2D | Change in Mental Health Quality of Living as Measured by the SF-12 | 0.5 score on a scale | Standard Deviation 2.7 |
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.
Time frame: Baseline, 3months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Evidence-based Care of NAFLD in T2D | 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
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.
Time frame: Baseline, 3months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Evidence-based Care of NAFLD in T2D | Change in Self-Efficacy Measured by the Managing Chronic Diseases (SEMCD) Score | 0.4 score on a scale | Standard Deviation 1.1 |
Secondary
Number of Participants in Whom Clinically-indicated Tests Were Ordered (e.g. Labs, Referral, Imaging).
Time frame: baseline, 3 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Evidence-based Care of NAFLD in T2D | Number of Participants in Whom Clinically-indicated Tests Were Ordered (e.g. Labs, Referral, Imaging). | Labs Ordered | 7 Participants |
| Evidence-based Care of NAFLD in T2D | Number of Participants in Whom Clinically-indicated Tests Were Ordered (e.g. Labs, Referral, Imaging). | Imaging Ordered | 2 Participants |
| Evidence-based Care of NAFLD in T2D | Number of Participants in Whom Clinically-indicated Tests Were Ordered (e.g. Labs, Referral, Imaging). | Hepatology referral placed | 1 Participants |
Secondary
Number of Participants With Changes to Medications During the Study Period Measured by Chart Review
Time frame: baseline, 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Evidence-based Care of NAFLD in T2D | Number of Participants With Changes to Medications During the Study Period Measured by Chart Review | 5 Participants |