Type 2 DiabetesNCT00295256
Randomized Trial to Evaluate the Effectiveness of Nurse Case Management
A study testing nurse case manager in people with Type 2 Diabetes and Gestational Diabetes, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Type 2 Diabetes, Gestational Diabetes, Hypertension
- What is being tested?
- nurse case manager
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Oct 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Type 2 diabetes, gestational diabetes, preterm labor, hypertensive disease
Who cannot join
- No telephone; ability to provide consent; english-speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Medical Institutions
Baltimore, Maryland, 21287
About this study
Official title: Randomized Trial to Evaluate the Effectiveness of Nurse Case Management on High-Risk Pregnancy Outcomes
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.
- Conditions
- Type 2 Diabetes, Gestational Diabetes, Hypertension, Preterm Delivery
- Being tested
- nurse case manager
- Keywords
- randomized trial, diabetes, pregnancy
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes, Gestational, Hypertension, Premature Birth, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nurse case managerBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcomes measures are mean fasting glucose levels, mean systolic pressure and mean diastolic pressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Sponsor
- Investigators
- Wanda Nicholson, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00295256
- Sponsor's protocol ID
- M630-430-2029
- Other IDs
- IRB number 05-01-28-03
- Status last verified
- Dec 2017
- First submitted
- 22 Feb 2006
- Last updated
- 7 Dec 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial to Evaluate the Effectiveness of Nurse Case Management on High-Risk Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT00295256
- Acronym / sponsor ID
- M630-430-2029
- Conditions
- Type 2 Diabetes, Gestational Diabetes, Hypertension, Preterm Delivery
- Keywords
- randomized trial, diabetes, pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- Feb 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 23 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 diabetes, gestational diabetes, preterm labor, hypertensive disease
Key exclusion criteria (1 listed)
- No telephone; ability to provide consent; english-speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nurse case manager | Behavioural | – |
Primary outcome
Outcomes measures are mean fasting glucose levels, mean systolic pressure and mean diastolic pressure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wanda Nicholson, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nurse case manager in people with Type 2 Diabetes and Gestational Diabetes, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcomes measures are mean fasting glucose levels, mean systolic pressure and mean diastolic pressure. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2017.