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Randomized Trial to Evaluate the Effectiveness of Nurse Case Management

Randomized Trial to Evaluate the Effectiveness of Nurse Case Management on High-Risk Pregnancy Outcomes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00295256
Enrollment
100
Registered
2006-02-23
Start date
2006-02-28
Completion date
2007-10-31
Last updated
2017-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes, Hypertension, Preterm Delivery, Type 2 Diabetes

Keywords

randomized trial, diabetes, pregnancy

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.

Interventions

BEHAVIORALnurse case manager

Sponsors

Robert Wood Johnson Foundation
CollaboratorOTHER
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Outcomes measures are mean fasting glucose levels, mean systolic pressure and mean diastolic pressure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026