Randomized Trial to Evaluate the Effectiveness of Nurse Case Management

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. Identifier: NCT00295256
Recruitment Status : Completed
First Posted : February 23, 2006
Last Update Posted : December 7, 2017
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Johns Hopkins University

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

Condition or disease Intervention/treatment
Type 2 Diabetes Gestational Diabetes Hypertension Preterm Delivery Behavioral: nurse case manager

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Study Start Date : February 2006
Primary Completion Date : October 2007
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Information from the National Library of Medicine

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

Inclusion Criteria:

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

Exclusion Criteria:

  • No telephone; ability to provide consent; english-speaking

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 identifier (NCT number): NCT00295256

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

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

Keywords provided by Johns Hopkins University:
randomized trial

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