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CompletedNCT00295256Updated Dec 7, 2017

Randomized Trial to Evaluate the Effectiveness of Nurse Case Management

An interventional study of nurse case manager in Type 2 Diabetes, Gestational Diabetes and Hypertension, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to female participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2017-12-07.

Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
15 Years and older
Sex
Female
01

Study 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

Read the 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.

02

Conditions studied

  • Type 2 Diabetes
  • Gestational Diabetes
  • Hypertension
  • Preterm Delivery

Keywords

  • randomized trial
  • diabetes
  • pregnancy
03

In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.

This study's planned enrollment of 100 is close to the median of 110 across 550 interventional studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.

Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • No telephone; ability to provide consent; english-speaking
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Interventions

  • Behavioralnurse case manager
06

What researchers measure

Primary outcomes

  1. Outcomes measures are mean fasting glucose levels, mean systolic pressure and mean diastolic pressure

07

Study locations

1 site
  • Johns Hopkins Medical Institutions
    Baltimore, Maryland 21287, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00295256
Lead sponsor
Johns Hopkins University
Collaborators
Robert Wood Johnson Foundation
Responsible party
Sponsor
First posted
Feb 23, 2006
Start date
Feb 2006
Primary completion
Oct 2007
Completion
Oct 2007
Last update
Dec 7, 2017

Study contacts

Wanda Nicholson, MD
principal investigator · Johns Hopkins University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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