Back to resultsRandomized Trial to Evaluate the Effectiveness of Nurse Case Management
Primary Purpose
Type 2 Diabetes, Gestational Diabetes, Hypertension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
nurse case manager
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring randomized trial, diabetes, pregnancy
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes, gestational diabetes, preterm labor, hypertensive disease Exclusion Criteria: No telephone; ability to provide consent; english-speaking
Sites / Locations
- Johns Hopkins Medical Institutions
Outcomes
Primary Outcome Measures
Outcomes measures are mean fasting glucose levels, mean systolic pressure and mean diastolic pressure
Secondary Outcome Measures
Full Information
NCT ID
NCT00295256
First Posted
February 22, 2006
Last Updated
December 5, 2017
Sponsor
Johns Hopkins University
Collaborators
Robert Wood Johnson Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00295256
Brief Title
Randomized Trial to Evaluate the Effectiveness of Nurse Case Management
Official Title
Randomized Trial to Evaluate the Effectiveness of Nurse Case Management on High-Risk Pregnancy Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Robert Wood Johnson Foundation
4. Oversight
5. Study Description
Brief Summary
The management of high-risk pregnancies require substantial use of medical resources. Our goal is to determine the effectiveness of a nurse case management program in which case managers are assigned to patients with high-risk conditions.
Our hypothesis is that women with diabetes in pregnancy or hypertension who are assigned a nurse case manager will have lower glucose levels and lower blood pressure levels
Detailed Description
We will recruit 50 women for each arm of the study. We we conduct a stratified randomization (by disease) in which women are randomized to a nurse case manager who provides on-going face-to-face contact compared to women who are assigned to a case manager with telephone contact only.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Gestational Diabetes, Hypertension, Preterm Delivery
Keywords
randomized trial, diabetes, pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
nurse case manager
Primary Outcome Measure Information:
Title
Outcomes measures are mean fasting glucose levels, mean systolic pressure and mean diastolic pressure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 diabetes, gestational diabetes, preterm labor, hypertensive disease
Exclusion Criteria:
No telephone; ability to provide consent; english-speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wanda Nicholson, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Medical Institutions
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Randomized Trial to Evaluate the Effectiveness of Nurse Case Management
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