CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,270 enrolled
Drug / intervention
IVR Intervention Groupbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02056431
NCT02056431N/ACompleted

Balancing Treatment Outcomes and Medication Burden Among Patients With Symptomatic Diabetic Peripheral Neuropathy

Kaiser Permanente·interventional·Posted Feb 6, 2014·Updated Jun 28, 2018

In Brief

A clinical study evaluating IVR Intervention Group for Diabetic Peripheral Neuropathy. Completed, enrolled 1,270 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 6, 2014
Enrollment StartOct 1, 2014
Primary CompletionJul 1, 2016
Study CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.4 years ago

Interventions

IVR Intervention Groupbehavioral

Participants will receive 3 interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) to collect information on medication use, side effects, rating of side effects, and pain symptoms to be fed back to their physicians.