Clinical trial NCT04924400: Complete Health Improvement Program for Geisinger Health Plan Members With Type 2 Diabetes
Official title: Complete Health Improvement Program to Improve Glycemic Control and Reduce Cost of Care for Geisinger Health Plan Members With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in HbA1c
timeFrame: 6 months
measure: Percentage of Patients Who Completed Biomarkers
timeFrame: 3 and 6 months
measure: Percentage of Patients Who Completed Biometrics
timeFrame: 3 and 6 months
measure: Percentage of Patients Contacted Who Agreed to Participate
timeFrame: Baseline
Secondary outcomes:
measure: HbA1c Control at 3 Months
timeFrame: 3 months
measure: LDL-C at 3 Months
timeFrame: 3 months
measure: Change in Weight at 3 Months
timeFrame: 3months
measure: Change in Weight at 6 Months
timeFrame: 6 months
measure: Health Behaviors, as Measured by CHIP Participation
timeFrame: 6 months
measure: Number of Diabetes Medications Prescribed at 6 Months
timeFrame: 6 months
measure: Change in LDL-C at 6 Months
timeFrame: 6 months
measure: Systolic Blood Pressure After 3 Months
timeFrame: 3 months
measure: Systolic Blood Pressure at 6 Months
timeFrame: 6 months
measure: Diastolic Blood Pressure at 6 Months
timeFrame: 6 months
measure: Diastolic Blood Pressure After 3 Months
timeFrame: 3 months
measure: Change in Total Cost of Care, Versus Same 6 Months Year Prior
timeFrame: 6 months of participation compared to same period one year prior
measure: Change in Total Cost of Care Versus 6 Months Leading to Intervention
timeFrame: 6 months beginning with first day of intervention versus 6 months leading up to that day
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Thomas B Morland, MD
role: PRINCIPAL_INVESTIGATOR
References: