Complete Health Improvement Program for Geisinger Health Plan Members With Type 2 Diabetes

Not Applicable

Completed

Conditions: Type 2 Diabetes

Interventions: Behavioral: CHIP Program
Behavioral: Usual Care

Registration Number: NCT04924400

Lead Sponsor: Thomas Morland

Brief Summary: The Complete Health Improvement Program (CHIP) is a lifestyle improvement program intended to prevent and/or manage cardiovascular disease, diabetes, and other health conditions. This is a pilot-scale randomized-controlled trial comparing the clinical, utilization, and financial outcomes of adult health plan members with type 2 diabetes mellitus (T2DM) offered CHIP versus those only offered standard health plan coverage. We hypothesize that Geisinger Health Plan (GHP) members with T2DM offered CHIP in addition to standard insurance coverage will have improvement in HbA1c and improvements in other biometrics, biomarkers, psychometrics and utilization/financial outcomes, including LDL-C, systolic blood pressure, body mass index, waist circumference, number of diabetes medications prescribed, Wellbeing360 survey, and total cost of healthcare.

Detailed Description: This is a pilot prospective randomized-controlled trial of 60 patients randomized to either the intervention group; in which patients enroll in the CHIP program, or the control group, in which patients follow their usual diabetes care. We hypothesize that Geisinger Health Plan members with T2DM offered CHIP in addition to standard insurance coverage will have improvement in HbA1c and improvements in other biometrics, biomarkers, psychometrics and utilization/financial outcomes, including LDL-C, systolic blood pressure, body mass index, waist circumference, number of diabetes medications prescribed, Wellbeing360 survey, and total cost of healthcare.

The intervention group will attend 18 classes covering topics such as diet, sleep, exercise instruction, stress management, and toxic substance avoidance. Biometrics (weight, BMI, waist circumference, systolic/diastolic blood pressure), biomarkers (HbA1c, LDL-C) and psychometrics (Wellbeing 360 survey) will be collected on all participants at baseline, 3-months and 6-months.

The CHIP curriculum will be administered during twice weekly 1-hour classes over a 6-week period, followed by weekly 1-hour classes for an additional 6 weeks. The protocol will begin with a 1-month in-person period, with participants subsequently offered the choice between in-person and online attendance for the remaining sessions.

The primary aim is to compare change in HbA1c, LDL-C, systolic blood pressure, body mass index, and waist circumference for GHP members offered CHIP versus members offered standard insurance coverage at 3- and 6-months.

Through this pilot study, we hope to gain insight into whether and how such an application of CHIP could be a cost-effective tool for health plans such as GHP to achieve clinical and financial goals for adult members with T2DM.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 38

Inclusion Criteria

Geisinger Health Plan member for a full year prior to enrollment in the study, with plans to remain covered for a full year after the first study visit
HbA1c resulted within a year of enrollment in the study
≥ 18 years
Current type 2 diabetes diagnosis
Living in the five-county region served by the Miller Center (Lycoming, Montour, Northumberland, Snyder and Union) with the ability to arrange their own transportation to the Miller Center in Lewisburg at least 10 times in a 3-month period
Access to computer, phone, or tablet with sufficient internet to complete program activities.

Exclusion Criteria

Presence of medical condition requiring specific diet (e.g., Celiac disease, phenylketonuria)
Presence of medical condition contraindicating participation in CHIP, as determined by the Principal Investigator (e.g. cancer on active treatment)
Pregnancy or plan to become pregnant within one year
Inability to give informed consent due to mental or psychiatric impairment
Participation in the Fresh Food Farmacy program

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHIP Program	CHIP Program	GHP members randomized to the intervention arm will participate in the CHIP Program.
Usual Diabetes Care	Usual Care	GHP members assigned to the control arm will receive the routine standard of care for GHP members.

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	6 months	Change in HbA1c after 6 months compared to baseline
Percentage of Patients Who Completed Biomarkers	3 and 6 months	What percentage of individuals completed biomarkers
Percentage of Patients Who Completed Biometrics	3 and 6 months	What percentage of individuals completed biometrics
Percentage of Patients Contacted Who Agreed to Participate	Baseline	What percentage of individuals contacted who agreed to participate in the study

Secondary Outcome Measures

Name	Time	Method
Number of Diabetes Medications Prescribed at 6 Months	6 months	Change in number of diabetes medications at 6 months compared to baseline. Number of diabetes medications, by medication class, were collected for each responding patient at 3 and 6 months. Due to small sample size and lack of reversing changes between 3 and 6 months (i.e. all changes made by 3 months were continued at 6-month mark, whereas some additional changes were made between 3 and 6 months), changes between months 1-3 and 4-6 were pooled into a single report of cumulative change between baseline and the 6-month mark).
Change in LDL-C at 6 Months	6 months	Change in LDL-C at 6 months compared to baseline
Systolic Blood Pressure After 3 Months	3 months	Change in systolic blood pressure at 3 months compared to baseline
Systolic Blood Pressure at 6 Months	6 months	Change in systolic blood pressure at 6 months compared to baseline
Diastolic Blood Pressure at 6 Months	6 months	Change in diastolic blood pressure at 6 months compared to baseline
Diastolic Blood Pressure After 3 Months	3 months	Change in diastolic blood pressure at 3 months compared to baseline
Change in Total Cost of Care, Versus Same 6 Months Year Prior	6 months of participation compared to same period one year prior	This outcome evaluates cost of care in the 6 months beginning to the first day of the CHIP program versus the same 6 months as patient's participation in the study one year prior to enrollment
Change in Total Cost of Care Versus 6 Months Leading to Intervention	6 months beginning with first day of intervention versus 6 months leading up to that day	This outcome evaluates cost of care in the 6 months beginning to the first day of the CHIP program versus the 6 months leading up to that date
HbA1c Control at 3 Months	3 months	Change in HbA1c percentage at 3 months compared to at baseline
LDL-C at 3 Months	3 months	Change in LDL-C levels at 3 compared to baseline
Change in Weight at 3 Months	3months	Change in weight at 3 months compared to baseline
Change in Weight at 6 Months	6 months	Change in weight at 6 months compared to baseline
Health Behaviors, as Measured by CHIP Participation	6 months	Overall program completion, defined as completing the majority of study activities