跳至主要内容
临床试验/NCT05541120
NCT05541120撤回不适用

Effect of Remote Patient Monitoring and Patient Education on Patient Activation and Glycemic Control in Individuals With Type 2 Diabetes

Tracy Jalbuena MD2 个研究点 分布在 1 个国家开始时间: 2022年10月18日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Mean change in HbA1c%

研究概览

简要总结

This is a randomized controlled trial of the use of Remote Patient Monitoring (RPM) compared to usual care among rural patients with poorly controlled type 2 diabetes. Usual care is defined as participation in Living Well with Diabetes/Virtual Diabetes Self-Management Program and Primary Care Provider evaluation and management at the providers' discretion, including medication adjustment or interventions, and other types of interventions depending on clinical judgement.

详细描述

Effect of Remote Patient Monitoring and Patient Education on Patient Activation and Glycemic Control in Individuals with Type 2 Diabetes

Summary

ABSTRACT

In 2021, the MaineHealth Telehealth team was awarded a five-year, $1.7 million "Evidence-Based Telehealth Network Program" grant (EB TNPG) from Health Resources and Services Administration (HRSA). This grant is aimed at improving patient access to educational and management services for patients with type 2 diabetes in the rural Maine primary care setting by implementing RPM. The RPM devices will be used to transmit a participant's home point-of-care blood glucose values directly into MaineHealth's electronic medical record in real time. While there is strong evidence for diabetes self-management programs such as Living Well with Diabetes, the importance of patient engagement in clinical outcomes, the validity of the Patient Activation Measure (PAM-13®) survey to measure patient activation, and the overall efficacy of remote patient monitoring, there have been no randomized controlled trials looking at patient activation in remote patient monitoring in this important patient group. The investigators aim to address this in this study by conducting a randomized controlled trial of the use of RPM among rural patients with poorly controlled type 2 diabetes. The control group will have usual primary care provider care, including patient self-management tools, while the intervention group will have usual care + RPM.

The investigators hypothesize that participation in RPM will be associated with decreases in HbA1c, increases in patient activation as measured by PAM-13® survey, and that increases in patient activation will be associated with decreases in HbA1c.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

入选标准

  • Be enrolled in Living Well with Diabetes education program
  • Have an HbA1c% ≥ 8 in the prior 6 months
  • Be capable of providing consent
  • Be adults (age 18 or over)

排除标准

  • Primarily managed by endocrinology for their diabetes (> 1 visit with endocrinology in the previous 12 months)
  • Incarcerated
  • PCP not at one of the 30 primary care practices listed (see attachment List of PCP Practices)
  • Diagnosed with type 1 diabetes
  • Candidate for continuous glucose monitoring, as defined by Centers for Medicare and Medicaid Services as using at least three insulin injections per day, any combination of types of insulins
  • Have previously participated in the Living Well with Diabetes/Virtual Diabetes Self-Management Program
  • Have previously used a remote patient monitoring device for diabetes management
  • Have a diagnosis of dementia or other clinical diagnosis that would impair participation capacity
  • Currently participating in any other clinical trial regarding diabetes care or management
  • Currently enrolled in hospice
  • Currently residing in a long term care or rehabilitation facility

结局指标

主要结局

Mean change in HbA1c%

时间窗: 9 months after enrollment

Average change in percentage of HbA1c from baseline to 9 months after enrollment

Percentage of participants in each group who have HbA1c < 7%

时间窗: 9 months after enrollment

Percentage of participants in each group with HbA1c \< 7%

Mean HbA1c%

时间窗: 9 months after enrollment

Average glycated hemoglobin

次要结局

  • Mean change in PAM-13 at 6 months(6 months after enrollment)
  • PAM-13 at 6 months after enrollment(6 months after enrollment)
  • PAM-13 at 9 months after enrollment(9 months after enrollment)
  • Mean change in PAM-13 at 9 months(9 months after enrollment)

研究者

发起方
Tracy Jalbuena MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Tracy Jalbuena MD

Clinical Lead for Telehealth

MaineHealth

研究点 (2)

Loading locations...

相似试验

Effect of Remote Patient Monitoring and Patient... | 临床试验