Enhancing mHealth Technology in the PCMH Environment to Activate Chronic Care Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 229
- 试验地点
- 4
- 主要终点
- Patient Activation Measure (PAM)
研究概览
简要总结
Multi-site feasibility study designed to assist type-2 diabetes patients in self-care activities. The study includes Bluetooth-enabled medical devices (i.e. scales, blood pressure cuffs, glucometers, and activity monitors) for both intervention and control groups. Those in the intervention group will have the devices linked too a mobile health care environment that provides key benefits that include: device data trending, reinforcing tailored behavioral messages, and enhanced communication with the clinic.
详细描述
Multi-site phased study, conducted within the Military Health System that includes a user-centered design phase and a patient centered medical home (PCMH)-based feasibility trial.
In Phase I the investigators will assess both patient and clinician preferences and usability regarding the enhancement of the enabling technology capabilities for Type 2 diabetes chronic self-care management. The data from the experience will be coded and analyzed by the research team and the technology will be adapted accordingly before Phase II.
Phase II research is a single-blinded 12-month feasibility study that seeks to include the enabling technology to support diabetes self-care management with tailored behavioral messaging aimed at reinforcing and encouraging self-care behavior based on patients' readiness. We have included safety thresholds that alert patients and clinical team under certain conditions.
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
- Single (Participant)
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
- •Men and women age 18 years or older,
- •Ability to understand and read English,
- •Be empanelled to one of the target PCMH sites, and
- •Diagnosed with type 2 diabetes.
排除标准
- •pregnant women,
- •non-English speaking patients,
- •receiving hospice care,
- •active cancer and treatment with chemotherapy or radiation therapy,
- •taking Coumadin,
- •recipient of gastric bypass or similar procedure,
- •diagnosis of uncontrolled hypothyroidism,
- •known Cushing's syndrome,
- •being treated with oral steroids,
- •known liver disease,
- •current diagnosis of cognitive impairments which would interfere with use of technology,
- •congestive heart failure New York Heart Association class 3 or 4,
- •inability to use a mobile device due to cognitive or physical impairments, and
- •PAM® score = 4 during initial screening.
结局指标
主要结局
Patient Activation Measure (PAM)
时间窗: Every 3 months during the 12-month trial
PAM is a validated survey measure of patient activation
次要结局
- Blood pressure(Every 4 months plus patient self-measurement during 12 -month trial)
- Glycosylated hemoglobin (HbA1C)(Every 4 months during 12-month trial)
- Low-density Lipoprotein (LDL)(Every 4 months during 12-month trial)
- Abdominal circumference(Every 4 months during 12-month trial)
- High-density Lipoprotein (HDL)(Every 4 months during 12-month trial)
- Summary of Diabetes Self-Care Activities (SDSCA)(Every 2 weeks during 12-month trial)