Impact of a Diabetes Transitions Tool Kit on Post-Hospitalization Glycemic Control (DTTK)
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|ClinicalTrials.gov Identifier: NCT01495975|
Recruitment Status : Completed
First Posted : December 20, 2011
Results First Posted : April 16, 2015
Last Update Posted : October 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Other: Diabetes Transitions Tool Kit||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of a Web-based Diabetes Transitions Tool Kit on Post-Hospitalization Glycemic Control|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||January 2014|
No Intervention: Usual Care
Usual care for diabetes in the 1 month after discharge.
Experimental: Diabetes Transitions Tool Kit
Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge.
Other: Diabetes Transitions Tool Kit
Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge.
- Glycemic Control [ Time Frame: 1 month from discharge ]Mean patient-day weighted glucose (from glucometer downloads) over the 30 days after discharge
- Diabetes Distress [ Time Frame: 1 month from discharge ]Measured by the Problem Areas in Diabetes (PAID) Questionnaire
- Diabetes Self-Management [ Time Frame: 1 month from discharge ]
- Unplanned Readmission or ED Visit [ Time Frame: 1 month after discharge ]Unplanned readmission to any hospital within 30 days of discharge. Emergency department admission to any hospital within 30 days of discharge.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01495975
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Nancy J Wei, MD||Massachusetts General Hospital|
|Principal Investigator:||Deborah J Wexler, MD||Massachusetts General Hospital|