Randomized Trial to Evaluate the Effectiveness of Nurse Case Management
Sponsor
Johns Hopkins University (Other)
Overall Status
Completed
CT.gov ID
NCT00295256
Collaborator
Robert Wood Johnson Foundation (Other)
100
1
19.9
5
Study Details
Study Description
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 | Phase |
|---|---|---|
|
N/A |
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 Design
Study Type:
Interventional
Anticipated 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
:
Feb 1, 2006
Actual Primary Completion Date
:
Oct 1, 2007
Actual Study Completion Date
:
Oct 1, 2007
Outcome Measures
Primary Outcome Measures
- Outcomes measures are mean fasting glucose levels, mean systolic pressure and mean diastolic pressure []
Eligibility Criteria
Criteria
Ages Eligible for Study:
15 Years
and Older
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00295256
Other Study ID Numbers:
- M630-430-2029
- IRB number 05-01-28-03
First Posted:
Feb 23, 2006
Last Update Posted:
Dec 7, 2017
Last Verified:
Dec 1, 2017
Keywords provided by Johns Hopkins University
Additional relevant MeSH terms: