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

Type 2 Diabetes Clinical Trial

— CHIP-RCT  

Official title:

Complete Health Improvement Program to Improve Glycemic Control and Reduce Cost of Care for Geisinger Health Plan Members With Type 2 Diabetes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04924400
• Other study ID #: 2020-0438
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2022
• Est. completion date: December 2022

Study information

• Verified date: March 2022
• Source: Geisinger Clinic
• Contact: Thomas B Morland, MD
• Phone: 570-214-5025
• Email: tmorland[@]geisinger.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• CHIP Program
GHP members randomized to the intervention arm will participate in the following activities: Attend 2 group meetings per week over 6 weeks, followed by one group meeting per week for 6 weeks (12 weeks total); each meeting will last about one hour. CHIP classes for weeks 1-4 and week 12 require in-person attendance, while week 5-11 classes can be attended either virtually or in-person. Receive a copy of The Optimal Diet, The Official CHIP Cookbook. The following data will be collected at weeks 1,12 and 26: Biometrics: weight, BMI, waist circumference, systolic and diastolic blood pressure Biomarkers (blood tests): HbA1c, LDL-C Psychometrics: Wellbeing360 survey
• Usual Care
GHP members assigned to the control arm will receive the routine standard of care for GHP members. Members will receive a summary of diabetes-related benefits available to members with type 2 diabetes. The following data will be collected at weeks 1,12 and 26: Biometrics: Weight, BMI, waist circumference, systolic and diastolic blood pressure Biomarkers (blood tests): HbA1c, LDL-C Psychometrics: Wellbeing360 survey

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Morland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	Change in HbA1c percentage at 6 months compared to baseline	6 months
Primary	Percentage of patients who complete the study	What percentage of individuals contacted agree to participate; what percentage of individuals contacted are excluded from the study based on lack of access to transportation or Internet; what percentage of participants enrolled complete the intervention?	6 months
Secondary	HbA1c control at 3 months	Change in HbA1c percentage at 3 months compared to at baseline	3 months
Secondary	LDL-C at 3 and 6 months	Change in LDL-C levels at 3 and 6 months compared to baseline	3 and 6 months
Secondary	Biometrics at 3 and 6 months	Change in weight, body mass index, blood pressure at 3 and 6 months compared to baseline	3 and 6 months
Secondary	Psychosocial/behavioral at 3 and 6 months	Change in Wellbeing360 survey at 3 and 6 months compared to baseline	3 and 6 months
Secondary	Health behaviors, as measured by CHIP participation	Overall program completion, attendance stratified by in-person versus online, proportion of required in-person attended	6 months
Secondary	Number of diabetes medications prescribed at 3 and 6 months	Change in number of diabetes medications at 3 and 6 months compared to baseline	3 and 6 months
Secondary	Total cost of care over 6 months.	Change in total cost of care at 6 months compared to baseline	6 months