We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Randomized Trial to Evaluate the Effectiveness of Nurse Case Management

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00295256
First Posted: February 23, 2006
Last Update Posted: December 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Johns Hopkins University
  Purpose

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


Condition Intervention
Type 2 Diabetes Gestational Diabetes Hypertension Preterm Delivery Behavioral: nurse case manager

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial to Evaluate the Effectiveness of Nurse Case Management on High-Risk Pregnancy Outcomes

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Outcomes measures are mean fasting glucose levels, mean systolic pressure and mean diastolic pressure

Estimated Enrollment: 100
Study Start Date: February 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes, gestational diabetes, preterm labor, hypertensive disease

Exclusion Criteria:

  • No telephone; ability to provide consent; english-speaking
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00295256


Locations
United States, Maryland
Johns Hopkins Medical Institutions
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Robert Wood Johnson Foundation
Investigators
Principal Investigator: Wanda Nicholson, MD Johns Hopkins University
  More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00295256     History of Changes
Other Study ID Numbers: M630-430-2029
IRB number 05-01-28-03
First Submitted: February 22, 2006
First Posted: February 23, 2006
Last Update Posted: December 7, 2017
Last Verified: December 2017

Keywords provided by Johns Hopkins University:
randomized trial
diabetes
pregnancy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Premature Birth
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications