Evaluation of a Telehealth DPP With Medicare Patients at the University of Mississippi Medical Center

NCT04822480 | Active Not Recruiting DMC

• 1 other identifier: 2020V0327
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The National Diabetes Prevention Program (DPP) is an evidence-based, 12-month lifestyle change program to prevent or delay the onset of type 2 diabetes mellitus (herein referred to as 'diabetes') among adults with prediabetes. The Department of Preventive Medicine, University of Mississippi Medical Center (UMMC), in partnership with the American Medical Association, is collaborating to develop and implement the DPP as a clinical service for UMMC patients beginning in September 2020. We aim to recruit 245 patients per year over 3 years. Because this is the first attempt to develop and implement the DPP as a clinical service at the UMMC, we are proposing to conduct a comprehensive process, outcome, impact and return on investment evaluation. An effectiveness-implementation hybrid research design will be used to (1) evaluate a multifaceted implementation strategy and the effectiveness and impact of the DPP delivered using telehealth by UMMC's Department of Preventive Medicine; (2) conduct an analysis on medical expenditures among those who participate in a DPP to measure net savings and return on investment (ROI) relative to non-participants; (3) conduct a longitudinal cohort analysis to assess incidence of diabetes and changes in body composition, biomarkers, and psycho-social behavioral constructs among those who participate in a DPP relative to those who do not. The findings from this comprehensive research evaluation will be used to (1) improve clinical operations and implementation; (2) demonstrate the cost benefit of the DPP as a clinical service for patients with diabetes risk; and (3) provide empirical support for delivering the DPP via different modalities including telehealth to reduce risk and improve health outcomes among patients.

Conditions

PreDiabetes; Prediabetic State

Keywords

diabetes prevention

Outcome Measures

Primary Outcomes (36)

• Type 2 diabetes mellitus diagnosis

  Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249

  Change diabetes diagnosis from baseline to 6-months in DPP compared with non-DPP patients

• Type 2 diabetes mellitus diagnosis

  Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249

  Change diabetes diagnosis from baseline to 12-months in DPP compared with non-DPP patients

• Type 2 diabetes mellitus diagnosis

  Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249

  Change diabetes diagnosis from baseline to 18-months in DPP compared with non-DPP patients

• Type 2 diabetes mellitus diagnosis

  Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249

  Change diabetes diagnosis from baseline to 24-months in DPP compared with non-DPP patients

• Type 2 diabetes mellitus diagnosis

  Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249

  Change diabetes diagnosis from baseline to 30-months in DPP compared with non-DPP patients

• Type 2 diabetes mellitus diagnosis

  Diabetes diagnosis extracted via electronic health record; all codes with prefix of 250 and 249

  Change diabetes diagnosis from baseline to 36-months in DPP compared with non-DPP patients

• Hemoglobin A1c

  Lab values extracted from electronic health record

  Change in HbA1c from baseline to 6-months in DPP compared with non-DPP patients

• Hemoglobin A1c

  Lab values extracted from electronic health record

  Change in HbA1c from baseline to 12-months in DPP compared with non-DPP patients

• Hemoglobin A1c

  Lab values extracted from electronic health record

  Change in HbA1c from baseline to 18-months in DPP compared with non-DPP patients

• Hemoglobin A1c

  Lab values extracted from electronic health record

  Change in HbA1c from baseline to 24-months in DPP compared with non-DPP patients

• Hemoglobin A1c

  Lab values extracted from electronic health record

  Change in HbA1c from baseline to 30-months in DPP compared with non-DPP patients

• Hemoglobin A1c

  Lab values extracted from electronic health record

  Change in HbA1c from baseline to 36-months in DPP compared with non-DPP patients

• Fasting plasma glucose

  Lab values extracted from electronic health record

  Change in fasting plasma glucose from baseline to 6-months in DPP compared with non-DPP patients

• Fasting plasma glucose

  Lab values extracted from electronic health record

  Change in fasting plasma glucose from baseline to 12-months in DPP compared with non-DPP patients

• Fasting plasma glucose

  Lab values extracted from electronic health record

  Change in fasting plasma glucose from baseline to 18-months in DPP compared with non-DPP patients

• Fasting plasma glucose

  Lab values extracted from electronic health record

  Change in fasting plasma glucose from baseline to 24-months in DPP compared with non-DPP patients

• Fasting plasma glucose

  Lab values extracted from electronic health record

  Change in fasting plasma glucose from baseline to 30-months in DPP compared with non-DPP patients

• Fasting plasma glucose

  Lab values extracted from electronic health record

  Change in fasting plasma glucose from baseline to 36-months in DPP compared with non-DPP patients

• 2-hour plasma glucose

  Lab values extracted from electronic health record

  Change in 2-hour plasma glucose from baseline to 6-months in DPP compared with non-DPP patients

• 2-hour plasma glucose

  Lab values extracted from electronic health record

  Change in 2-hour plasma glucose from baseline to 12-months in DPP compared with non-DPP patients

• 2-hour plasma glucose

  Lab values extracted from electronic health record

  Change in 2-hour plasma glucose from baseline to 18-months in DPP compared with non-DPP patients

• 2-hour plasma glucose

  Lab values extracted from electronic health record

  Change in 2-hour plasma glucose from baseline to 24-months in DPP compared with non-DPP patients

• 2-hour plasma glucose

  Lab values extracted from electronic health record

  Change in 2-hour plasma glucose from baseline to 30-months in DPP compared with non-DPP patients

• 2-hour plasma glucose

  Lab values extracted from electronic health record

  Change in 2-hour plasma glucose from baseline to 36-months in DPP compared with non-DPP patients

• Medical encounters

  Extracted from electronic health record

  Number of medical encounters between baseline and 6-months in DPP compared with non-DPP patients

• Medical encounters

  Extracted from electronic health record

  Number of medical encounters between baseline and 12-months in DPP compared with non-DPP patients

• Medical encounters

  Extracted from electronic health record

  Number of medical encounters between baseline and 18-months in DPP compared with non-DPP patients

• Medical encounters

  Extracted from electronic health record

  Number of medical encounters between baseline and 24-months in DPP compared with non-DPP patients

• Medical encounters

  Extracted from electronic health record

  Number of medical encounters between baseline and 30-months in DPP compared with non-DPP patients

• Medical encounters

  Extracted from electronic health record

  Number of medical encounters between baseline and 36-months in DPP compared with non-DPP patients

• Medical expenditures

  Total dollar amount billed per encounter extracted from electronic health record

  Medical expenditures from baseline to 6-months in DPP compared with non-DPP patients

• Medical expenditures

  Total dollar amount billed per encounter extracted from electronic health record

  Medical expenditures from baseline to 12-months in DPP compared with non-DPP patients

• Medical expenditures

  Total dollar amount billed per encounter extracted from electronic health record

  Medical expenditures from baseline to 18-months in DPP compared with non-DPP patients

• Medical expenditures

  Total dollar amount billed per encounter extracted from electronic health record

  Medical expenditures from baseline to 24-months in DPP compared with non-DPP patients

• Medical expenditures

  Total dollar amount billed per encounter extracted from electronic health record

  Medical expenditures from baseline to 30-months in DPP compared with non-DPP patients

• Medical expenditures

  Total dollar amount billed per encounter extracted from electronic health record

  Medical expenditures from baseline to 36-months in DPP compared with non-DPP patients

Secondary Outcomes (104)

• Body weight

  Change in body weight from baseline to 6-months

• Body weight

  Change in body weight from baseline to 12-months

• Body weight

  Change in body weight from baseline to 24-months

• Body weight

  Change in body weight from baseline to 36-months

• Fat mass

  Change in fat mass from baseline to 6-months

Other Outcomes (61)

• Eligible DPP patients (reach)

  Baseline to 3-months

• Eligible DPP patients (reach)

  Baseline to 6-months

• Eligible DPP patients (reach)

  Baseline to 9-months

Study Arms (2)

DPP Patients

UMMC Patients with prediabetes or risk for diabetes based on risk parameters referred to and enrolled in the DPP.

Behavioral: Diabetes Prevention Program (DPP)

Non-DPP Patients

Control matched UMMC patients with prediabetes or risk for diabetes based on risk parameters not enrolled in the DPP.

Interventions

Diabetes Prevention Program (DPP) BEHAVIORAL

Individuals with prediabetes can mitigate the risks and costs of diabetes by taking preventative action, such as participation in a National Diabetes Prevention Program (DPP). The DPP began as a multisite randomized controlled trial demonstrating the effectiveness and cost-benefit of a 12-month intensive lifestyle intervention over pharmaceutical treatment for preventing or delaying diabetes among prediabetic participants. In 2010, Congress authorized the Centers for Disease Control and Prevention to lead the dissemination of the DPP as a targeted approach (high risk populations) and population-based strategy to reduce the incidence of diabetes and diabetes-related healthcare costs. The goal is to achieve modest weight loss (7%) by developing and implementing behavior change skills resulting in lifestyle modifications such as physical activity (150 minutes per week) and dietary and nutritional practices.

DPP Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Mississippi consistently has among the highest rates of diabetes (14.3%) and prediabetes (36.5%) nationally and is the only state where every county (82 counties) are represented in the Diabetes Belt, a geographic region of the U.S. where the prevalence of diagnosed diabetes is highest. Mississippi has the fourth largest rural population (51.2%) and the highest state percent Black (37.8%) population in the U.S., and has persistently high rates of poverty (20.8%).

You may qualify if:

• UMMC patient within the previous 3-years (at least one UMMC clinical visit within the previous 3-years)
• ≥ 18 years AND
• Clinical diagnosis for prediabetes (R73.03)
• OR any of the following combinations:
• BMI ≥25 (non-Asian) OR
• BMI ≥23 (Asian) AND
• HbA1c 5.7 - 6.4 percent within the past 12-months OR
• Fasting plasma glucose 110 - 125 mg/dL within the past 12-months OR
• hour plasma glucose 140 - 199 mg/dL within the past 12-months

You may not qualify if:

• Pregnant or planning to become pregnant within the next 12 months
• \<18 years
• Primary or secondary diagnosis of diabetes mellitus (all codes with prefix of 250 and 249) and other conditions associated with diabetes (357.2, all codes with prefix 362, 366.41, and all codes with prefix 648).
• End stage renal disease

Sponsors & Collaborators

• University of Mississippi Medical Center: lead
• American Medical Association: collaborator
• Mississippi State Department of Health: collaborator

Study Sites (1)

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (1)

• Gamble A, Khan T, Hughes A, Guo Y, Vasaitis S, Bidwell J, Christman B. Telehealth Diabetes Prevention Program for Adults With Prediabetes in an Academic Medical Center Setting: Protocol for a Hybrid Type III Trial. JMIR Res Protoc. 2023 Nov 13;12:e50183. doi: 10.2196/50183.

  PMID: 37955955 DERIVED

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Abigail Gamble, PhD, MS

  University of Mississippi Medical Center

  PRINCIPAL INVESTIGATOR

• Tamkeen Khan, PhD

  American Medical Association

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Preventive Medicine and Population Health Science

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 30, 2021
• Study Start: February 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)