跳至主要内容
临床试验/NCT01495975
NCT01495975已完成不适用

Impact of a Web-based Diabetes Transitions Tool Kit on Post-Hospitalization Glycemic Control

Deborah Wexler, MD1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2011年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
29
试验地点
1
主要终点
Glycemic Control

研究概览

简要总结

The goal of this research is to evaluate the impact and feasibility of using web-based patient-provider communication and a remote glucose monitoring tool to improve post-hospitalization glycemic control and patient self-care. The investigators hypothesize that providing patients this web-based tool over a 4-week period after discharge to home will result in more effective glycemic control compared to usual care, and that patients with access to the "tool kit" will have a trend towards improved diabetes self-management and less diabetes-related distress.

详细描述

Diabetes affects 12-25% of all hospitalized adult patients, and 30% of hospitalized diabetes patients have one or more readmissions within one year. While glycemic control is rarely the primary reason for admission, poor glycemic control has been associated with increased rates of hospitalization and worse clinical outcomes, including infections, poor wound healing, and death. Hospitalization has been proposed as a "teachable moment" for patients with diabetes, as they have intensive contact with a full range of expert clinicians, but the effects of changes implemented during hospitalization after discharge are poorly studied.

The objective of this study is to conduct a randomized controlled trial to test a novel approach to diabetes management in the transition from inpatient to outpatient care. We will assign 40 hospitalized adult patients with type 2 diabetes to usual care or access to a web-based patient-provider communication and remote glucose monitoring tool ("Diabetes Transitions Tool Kit"). Our aims are to evaluate feasibility of implementation of the tool as well as impact on post-discharge glycemic control, diabetes-related self-care and distress. We hypothesize that providing patients this web-based tool over a 4-week period after discharge to home will result in more effective glycemic control compared to usual care, and that patients with access to the "tool kit" will have a trend towards improved diabetes self-management and less diabetes-related distress. Feasibility and preliminary data from this pilot study will be the foundation for larger-scale interventions that may ultimately improve the delivery of diabetes care in the transition from hospital to home.

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
否

入选标准

  • •Age 18 years or older
  • •English speaking and able to read English
  • •Diagnosis of type 2 diabetes (new and pre-existing)
  • •Hospital admission with endocrinology or inpatient diabetes management consult
  • •On insulin during hospitalization with plan for continuation upon discharge.
  • •Discharge planned for home.
  • •Access to the internet and an active email account throughout the 6-week study period.

排除标准

  • •Inability to connect to, navigate, and utilize the web-based system, or designate someone who is capable of using the system.
  • •No identifiable outpatient healthcare provider.
  • •Pregnancy, ruled out by urine hCG test after consent is obtained in all women who continue to have menstrual cycles.
  • •End-stage liver disease with prothrombin time >15 seconds and albumin <3 mg/dL.
  • •Hypoglycemia unawareness: patient lacks sensation of common signs of blood glucose <60 mg/dL (tachycardia, diaphoresis, hunger, confusion, fatigue).
  • •Projected survival <1 year.

研究组 & 干预措施

Usual Care

No Intervention

Usual care for diabetes in the 1 month after discharge.

Diabetes Transitions Tool Kit

Experimental

Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge.

干预措施: Diabetes Transitions Tool Kit (Other)

结局指标

主要结局

Glycemic Control

时间窗: 1 month from discharge

Mean patient-day weighted glucose (from glucometer downloads) over the 30 days after discharge

次要结局

  • Unplanned Readmission or ED Visit(1 month after discharge)
  • Diabetes Self-Management(1 month from discharge)
  • Diabetes Distress(1 month from discharge)

研究者

发起方
Deborah Wexler, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Deborah Wexler, MD

Principal Investigator

Massachusetts General Hospital

研究点 (1)

Loading locations...

相似试验