Complete Health Improvement Program to Improve Glycemic Control and Reduce Cost of Care for Geisinger Health Plan Members With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change in HbA1c
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Change in HbA1c
时间窗: 6 months
Change in HbA1c after 6 months compared to baseline
Percentage of Patients Who Completed Biomarkers
时间窗: 3 and 6 months
What percentage of individuals completed biomarkers
Percentage of Patients Who Completed Biometrics
时间窗: 3 and 6 months
What percentage of individuals completed biometrics
Percentage of Patients Contacted Who Agreed to Participate
时间窗: Baseline
What percentage of individuals contacted who agreed to participate in the study
次要结局
- Number of Diabetes Medications Prescribed at 6 Months(6 months)
- Change in LDL-C at 6 Months(6 months)
- Systolic Blood Pressure at 6 Months(6 months)
- Systolic Blood Pressure After 3 Months(3 months)
- Diastolic Blood Pressure at 6 Months(6 months)
- Diastolic Blood Pressure After 3 Months(3 months)
- Change in Total Cost of Care, Versus Same 6 Months Year Prior(6 months of participation compared to same period one year prior)
- 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)
- HbA1c Control at 3 Months(3 months)
- LDL-C at 3 Months(3 months)
- Change in Weight at 3 Months(3months)
- Change in Weight at 6 Months(6 months)
- Health Behaviors, as Measured by CHIP Participation(6 months)
研究者
Thomas Morland
Sponsor-Investigator
Geisinger Clinic