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N/A N=1,270 Randomized Double-blind Supportive Care

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

Diabetic Peripheral Neuropathy

Enrolled (actual)
1,270
Serious AEs
22.6%
Results posted
Feb 2018
Primary outcome: Primary: Change in Patient Quality of Life at Baseline and 8 Months — 0.66; 0.65; 0.68; 0.68 units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
IVR Intervention Group (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Kaiser Permanente
Primary completion
Jul 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Patient Quality of Life at Baseline and 8 Months
0.66; 0.65; 0.68; 0.68
SECONDARY
Number of Participants With Minimally Effective Dose in 12 Months
299; 290

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

Eligibility Criteria

Inclusion Criteria

  • All patients newly prescribed medication to treat diabetic peripheral neuropathy symptoms.

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02056431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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