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NCT00935441 · ClinicalTrials.gov registry record · NA
Effect of Case-Management Using Home Monitoring on Diabetes and Blood Pressure Outcomes
A NA study of Diabetes Mellitus, sponsored by Minneapolis Veterans Affairs Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 460
- Enrollment target
- 1
- Study location
NCT00935441 is a NA study of Diabetes Mellitus that has completed, run by Minneapolis Veterans Affairs Medical Center. The registered enrollment target is 460 participants, below the 1,865-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00935441, a NA study of Diabetes Mellitus, has completed, sponsored by Minneapolis Veterans Affairs Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 460 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized trial designed to determine if adoption of the chronic care model in conjunction with nurse case management, home telemonitoring, and home HbA1c monitoring can improve glycemic control compared to patients receiving usual case management. We hypothesize that nurse case management, with home telemonitoring of blood sugars and home HbA1c measurement will result in additional improvements in glycemic control compared to isolated nurse case management. Specifically, the telemonitoring group will have an HbA1c 0.5% lower compared to usual nurse case management. Secondary aims include an additional 5 mmHg improvement in systolic blood pressure (among patients with hypertension at the time of enrollment), improved patient satisfaction with treatment, improved medication adherence, reduced incidence of hypoglycemia, and reduced case manager time in the telemonitoring/home HbA1c group compared with usual caes management. The study will enroll 460 diabetic patients with HbA1c values greater than 8.5%, age 75 years or younger, who have a active land-line for telephone communication. Patients will be enrolled and actively case managed for 9 months.
Conditions Studied
Interventions
- BEHAVIORAL case management with telemonitoring
- BEHAVIORAL usual case management
Study Locations (1)
Minnesota
- Minneapolis VAMC - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 460 participants |
| Start Date | 2009-06 |
| Est. Completion | 2011-09 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00935441
The ClinicalTrials.gov registry entry for NCT00935441 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 460 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,865-participant average among 208 other Diabetes Mellitus trials with a reported enrollment target (75% lower). The listed sponsor is Minneapolis Veterans Affairs Medical Center, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which case management with telemonitoring is the first listed.
NCT00935441 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT00935441 about?
NCT00935441 is a clinical study titled "Effect of Case-Management Using Home Monitoring on Diabetes and Blood Pressure Outcomes". This is a randomized trial designed to determine if adoption of the chronic care model in conjunction with nurse case management, home telemonitoring, and home HbA1c monitoring can improve glycemic control compared to patients receiving usual case management. We hypothesize that nurse case managemen...
What is the current status of trial NCT00935441?
This trial is currently completed. It is a NA study. The enrollment target is 460 participants. The study started on 2009-06. Estimated completion is 2011-09.
What conditions does trial NCT00935441 study?
This clinical trial studies the following conditions: Diabetes Mellitus.
What interventions are being tested in trial NCT00935441?
The interventions under investigation include: case management with telemonitoring (BEHAVIORAL), usual case management (BEHAVIORAL).
Who is sponsoring clinical trial NCT00935441?
This trial is sponsored by Minneapolis Veterans Affairs Medical Center, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00935441 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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