Randomized Trial to Evaluate the Effectiveness of Nurse Case Management

Not Applicable

Completed

• Conditions: Gestational Diabetes; Type 2 Diabetes; Hypertension; Preterm Delivery

• Registration Number: NCT00295256
• Lead Sponsor: 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

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 Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-02-22
• Study First Submitted QC: 2006-02-22
• Study First Posted: 2006-02-23
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-05
• Last Update Posted: 2017-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Outcomes measures are mean fasting glucose levels, mean systolic pressure and mean diastolic pressure

Trial Locations

Locations (1)

Johns Hopkins Medical Institutions; 🇺🇸 Baltimore, Maryland, United States