Impact of a Diabetes Transitions Tool Kit on Post-Hospitalization Glycemic Control (DTTK)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Massachusetts General Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Deborah Wexler, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01495975
First received: December 14, 2011
Last updated: April 18, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Other: Diabetes Transitions Tool Kit

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of a Web-based Diabetes Transitions Tool Kit on Post-Hospitalization Glycemic Control

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Glycemic Control [ Time Frame: 1 month from discharge ] [ Designated as safety issue: No ]
    Mean glucose (from glucometer downloads) over the 30 days after discharge, and change in glycated albumin from hospitalization to 30 days after discharge.


Secondary Outcome Measures:
  • Diabetes Distress [ Time Frame: 1 month from discharge ] [ Designated as safety issue: No ]
    Measured by the Problem Areas in Diabetes (PAID) Questionnaire

  • Diabetes Self-Management [ Time Frame: 1 month from discharge ] [ Designated as safety issue: No ]
  • Unplanned Readmission or ED visit [ Time Frame: 1 month after discharge ] [ Designated as safety issue: No ]
    Unplanned readmission to any hospital within 30 days of discharge. Emergency department admission to any hospital within 30 days of discharge.


Estimated Enrollment: 40
Study Start Date: December 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01495975

Contacts
Contact: Nancy J Wei, MD 617-724-7597 ncwei@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Sub-Investigator: Nancy J Wei, MD         
Principal Investigator: Deborah J Wexler, MD         
Sponsors and Collaborators
Deborah Wexler, MD
Investigators
Principal Investigator: Nancy J Wei, MD Massachusetts General Hospital
Principal Investigator: Deborah J Wexler, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Deborah Wexler, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01495975     History of Changes
Other Study ID Numbers: 2011p-001573, 5K23DK080228-05
Study First Received: December 14, 2011
Last Updated: April 18, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Massachusetts General Hospital:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hospitalization
Patient Discharge

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 16, 2014