Randomized Trial to Evaluate the Effectiveness of Nurse Case Management

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by Johns Hopkins University.
Recruitment status was  Recruiting
Robert Wood Johnson Foundation
Information provided by:
Johns Hopkins University
ClinicalTrials.gov 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
Preterm Delivery
Behavioral: nurse case manager

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
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
Genders 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 ClinicalTrials.gov identifier: NCT00295256

Contact: Wanda Nicholson, MD 443-287-6942 wnichol@jhmi.edu
Contact: Payal Ghosh, BA 443-287-6942 pghos2@jhmi.edu

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

ClinicalTrials.gov 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
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
randomized trial

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

ClinicalTrials.gov processed this record on May 30, 2016