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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00295256
Other study ID # M630-430-2029
Secondary ID IRB number 05-01
Status Completed
Phase N/A
First received February 22, 2006
Last updated December 5, 2017
Start date February 2006
Est. completion date October 2007

Study information

Verified date December 2017
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date October 2007
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender Female
Age group 15 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design


Intervention

Behavioral:
nurse case manager


Locations

Country Name City State
United States Johns Hopkins Medical Institutions Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Johns Hopkins University Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Outcomes measures are mean fasting glucose levels, mean systolic pressure and mean diastolic pressure
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