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Randomized Trial to Evaluate the Effectiveness of Nurse Case Management

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2006 by Johns Hopkins University.
Recruitment status was:  Recruiting
Robert Wood Johnson Foundation
Information provided by:
Johns Hopkins University Identifier:
First received: February 22, 2006
Last updated: September 13, 2006
Last verified: September 2006

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

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
Estimated Study Completion Date: October 2007
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.

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
  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 identifier: NCT00295256

Contact: Wanda Nicholson, MD 443-287-6942
Contact: Payal Ghosh, BA 443-287-6942

United States, Maryland
Johns Hopkins Medical Institutions Recruiting
Baltimore, Maryland, United States, 21287
Principal Investigator: Wanda Nicholson, Md         
Sponsors and Collaborators
Johns Hopkins University
Robert Wood Johnson Foundation
Principal Investigator: Wanda Nicholson, MD Johns Hopkins University
  More Information Identifier: NCT00295256     History of Changes
Other Study ID Numbers: M630-430-2029
IRB number 05-01-28-03
Study First Received: February 22, 2006
Last Updated: September 13, 2006

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 processed this record on September 21, 2017