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NCT02056431 · ClinicalTrials.gov registry record · NA
Balancing Treatment Outcomes and Medication Burden Among Patients With Symptomatic Diabetic Peripheral Neuropathy
A NA study, sponsored by Kaiser Permanente.
- Completed
- Registry status
- NA
- Development phase
- 1,270
- Enrollment target
NCT02056431 is a NA study that has completed, run by Kaiser Permanente. The registered enrollment target is 1,270 participants.
The verdict
NCT02056431, a NA study, has completed, sponsored by Kaiser Permanente.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,270 participants
- Enrollment target
Study Summary
Painful diabetic peripheral neuropathy (DPN) affects more than 5.5 million people with diabetes. People with painful DPN have trouble sleeping, participating in social events, and conducting daily activities such as going to the store. Several prescription medications are available for the treatment of DPN symptoms, but none work perfectly and all have side effects that may be difficult for some patients. When patients report their symptoms and side effects to their doctor, they provide the doctor with important information to help them make adjustments to treatment that will help with symptoms and that the patient can tolerate in terms of side effects. In some cases, doctors may encourage patients to make these changes on their own at home based on their experience with therapy. However, patients may have a long time between visits to their doctor and may have trouble describing their symptoms to their doctor during a brief 10 to 15 minute visit. This clinical trial explores the possibility of computerized telephone calls to patients (Interactive Voice Response, IVR, technology) to gather information about treatment experiences that can then be reported to the doctor or used to guide patients to make changes in how they take the medication. It addresses the following question: Can routinely asking patients about their experiences with medications and using that information to encourage clinically appropriate titration improve patient quality of life? The investigators hypothesize that systematic collection and feedback of information about DPN treatment preferences and experience from newly treated patients to their primary care physician will facilitate treatment changes that improve patient outcomes
Interventions
- BEHAVIORAL IVR Intervention Group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,270 participants |
| Start Date | 2014-10 |
| Est. Completion | 2016-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02056431
The ClinicalTrials.gov registry entry for NCT02056431 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1,270 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kaiser Permanente, which has 294 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which IVR Intervention Group is the first listed.
NCT02056431 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02056431 about?
NCT02056431 is a clinical study titled "Balancing Treatment Outcomes and Medication Burden Among Patients With Symptomatic Diabetic Peripheral Neuropathy". Painful diabetic peripheral neuropathy (DPN) affects more than 5.5 million people with diabetes. People with painful DPN have trouble sleeping, participating in social events, and conducting daily activities such as going to the store. Several prescription medications are available for the treatment...
What is the current status of trial NCT02056431?
This trial is currently completed. It is a NA study. The enrollment target is 1,270 participants. The study started on 2014-10. Estimated completion is 2016-09.
What interventions are being tested in trial NCT02056431?
The interventions under investigation include: IVR Intervention Group (BEHAVIORAL).
Who is sponsoring clinical trial NCT02056431?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
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