Complete Health Improvement Program for Geisinger Health Plan Members With Type 2 Diabetes (CHIP-RCT)
Primary Purpose
Type 2 Diabetes
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CHIP Program
Usual Care
Sponsored by
About this trial
This is an interventional other trial for Type 2 Diabetes focused on measuring Type 2 Diabetes
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
CHIP Program
Usual Diabetes Care
Arm Description
GHP members randomized to the intervention arm will participate in the CHIP Program.
GHP members assigned to the control arm will receive the routine standard of care for GHP members.
Outcomes
Primary Outcome Measures
Change in HbA1c
Change in HbA1c percentage at 6 months compared to baseline
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?
Secondary Outcome Measures
HbA1c control at 3 months
Change in HbA1c percentage at 3 months compared to at baseline
LDL-C at 3 and 6 months
Change in LDL-C levels at 3 and 6 months compared to baseline
Biometrics at 3 and 6 months
Change in weight, body mass index, blood pressure at 3 and 6 months compared to baseline
Psychosocial/behavioral at 3 and 6 months
Change in Wellbeing360 survey at 3 and 6 months compared to baseline
Health behaviors, as measured by CHIP participation
Overall program completion, attendance stratified by in-person versus online, proportion of required in-person attended
Number of diabetes medications prescribed at 3 and 6 months
Change in number of diabetes medications at 3 and 6 months compared to baseline
Total cost of care over 6 months.
Change in total cost of care at 6 months compared to baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04924400
Brief Title
Complete Health Improvement Program for Geisinger Health Plan Members With Type 2 Diabetes
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2022 (Anticipated)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thomas Morland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 Diabetes
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CHIP Program
Arm Type
Active Comparator
Arm Description
GHP members randomized to the intervention arm will participate in the CHIP Program.
Arm Title
Usual Diabetes Care
Arm Type
Active Comparator
Arm Description
GHP members assigned to the control arm will receive the routine standard of care for GHP members.
Intervention Type
Behavioral
Intervention Name(s)
CHIP Program
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in HbA1c
Description
Change in HbA1c percentage at 6 months compared to baseline
Time Frame
6 months
Title
Percentage of patients who complete the study
Description
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?
Time Frame
6 months
Secondary Outcome Measure Information:
Title
HbA1c control at 3 months
Description
Change in HbA1c percentage at 3 months compared to at baseline
Time Frame
3 months
Title
LDL-C at 3 and 6 months
Description
Change in LDL-C levels at 3 and 6 months compared to baseline
Time Frame
3 and 6 months
Title
Biometrics at 3 and 6 months
Description
Change in weight, body mass index, blood pressure at 3 and 6 months compared to baseline
Time Frame
3 and 6 months
Title
Psychosocial/behavioral at 3 and 6 months
Description
Change in Wellbeing360 survey at 3 and 6 months compared to baseline
Time Frame
3 and 6 months
Title
Health behaviors, as measured by CHIP participation
Description
Overall program completion, attendance stratified by in-person versus online, proportion of required in-person attended
Time Frame
6 months
Title
Number of diabetes medications prescribed at 3 and 6 months
Description
Change in number of diabetes medications at 3 and 6 months compared to baseline
Time Frame
3 and 6 months
Title
Total cost of care over 6 months.
Description
Change in total cost of care at 6 months compared to baseline
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas B Morland, MD
Phone
570-214-5025
Email
tmorland@geisinger.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Avery M Schulze, MPH
Phone
570-214-4215
Email
amschulze@geisinger.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas B Morland, MD
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Complete Health Improvement Program for Geisinger Health Plan Members With Type 2 Diabetes
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