Evaluation of a Telehealth Personal Health Planning Program for Patients With Uncontrolled Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Hemoglobin A1c
研究概览
简要总结
The primary objective of the study is to evaluate implementation and determine the effectiveness of a telehealth personal health planning program for individuals with uncontrolled Type 2 Diabetes Mellitus. For this study, participants will be randomized into either the Telehealth Program or the standard of care group. The personal health planning (PHP) Type 2 Diabetes program is a virtual, 8 session/16- week behavioral health program. The program includes development of a personal health plan supported by a patient-provider health risk assessment; group session structure supplemented by educational, on-demand video sessions; lessons, discussions, and activities based on understanding behavioral modification, health engagement, and diabetes distress; goal progress tracking; social support; mindful awareness practices; 3 and 6-month post program sessions and qualitative health evaluations via surveys and a one-on-one consultation with a personal health coach. Those in the control group will receive usual care by the participants personal care team. All participants will come to the Duke Research at Pickett Road facility for a pre and post-program fasting A1C and lipid panel blood draw (if required).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Type 2 Diabetes diagnosis
- •18 and over
- •2 A1C results in last 18 months
- •A1C of 8-12
- •Access to a electronic device with internet
- •Duke Patient
排除标准
- •Type 1 Diabetes
- •Cognitive Impairment
研究组 & 干预措施
Personalized Health Planning Program Participant with Type 2 Diabetes
A novel virtual group visit care model for individuals with T2D for long-term health improvements and disease management. This intervention group will receive a 16-week virtual, Personal Health Planning (PHP) T2D Program emphasizing behavioral engagement, utilizing a mixed methods research design. Outcomes include cardiometabolic labs and surveys.
干预措施: Personalized Health Planning Program Administration (Other)
Usual Care (Type 2 DM)
The control group will receive usual care. They will be asked to have laboratory tests and answer survey questions regarding diabetes distress and diabetes empowerment.
干预措施: Usual Care (Other)
结局指标
主要结局
Hemoglobin A1c
时间窗: Day 1 (Preintervention) and Month 5 (Postintervention)
Blood test to determine average blood sugar
次要结局
- Systolic Blood Pressure(Day 1 (Preintervention) and Month 5 (Postintervention))
- Attendance at Personalized Health Program Group Meetings(16 weeks)
- Triglycerides(Day 1 (Preintervention) and Month 5 (Postintervention))
- Body Mass Index (BMI)(Day 1 (Preintervention) and Month 5 (Postintervention))
- Diastolic Blood Pressure(Day 1 (Preintervention) and Month 5 (Postintervention))
- Hemoglobin A1c(Month 17)
- Patient Goals Progress(Sessions 3-8 during the intervention)
- Fasting Plasma Glucose(Day1 (preintervention), Month 5 (post intervention), Month 17 (1 year post intervention))
- Diabetes Empowerment Scale(Day 1 (Preintervention) and Month 5 (Postintervention))
- Diabetes Distress(Day 1 (Preintervention) and Month 5 (Postintervention))
- HDL Cholesterol(Day 1 (Preintervention) and Month 5 (Postintervention))
- LDL Cholesterol(Day 1 (Preintervention) and Month 5 (Postintervention))
- Total Cholesterol(Day 1 (Preintervention) and Month 5 (Postintervention))