Balancing Treatment Outcomes and Medication Burden Among Patients With Symptomatic Diabetic Peripheral Neuropathy
Completed · Not applicable
Conditions studied: Diabetic Peripheral Neuropathy
In brief
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
Key facts
- Study ID
- NCT02056431
- Run by
- Kaiser Permanente
- People needed
- 1270
- Starts
- 2014-10-01
- Expected to finish
- 2016-09-01
- Last updated by the study team
- 2018-06-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All patients newly prescribed medication to treat diabetic peripheral neuropathy symptoms.
You may not qualify if…
- Patients with any evidence of use of diabetic peripheral neuropathy study medications.
- Patients with evidence of gestational diabetes (ICD-9: 648.8) due to variation in treatment and monitoring for women who are pregnant.
- Patients who simultaneously received a new diagnosis for depression or seizure conditions
Where it is running
- Division of Research Kaiser Permanente — Oakland, California, United States
Full record on ClinicalTrials.gov
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