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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Kaiser Permanente
Sponsor:
Collaborator:
Patient Centered Outcome Research Institute
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT02056431
First received: January 31, 2014
Last updated: November 18, 2014
Last verified: November 2014
  Purpose

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


Condition Intervention
Diabetic Peripheral Neuropathy
Behavioral: IVR Intervention Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Balancing Treatment Outcomes and Medication Burden Among Patients With Symptomatic Diabetic Peripheral Neuropathy

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Change from Baseline in Patient Quality of Life at 7 months [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient and physician initiated changes in medication in the treatment regimen (e.g. discontinuation). [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 2124
Study Start Date: May 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IVR Intervention Group
1,062 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.
Behavioral: IVR Intervention Group
1,062 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.
No Intervention: IVR Control Group
1,062 participants will receive 3 non-interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) containing general messages regarding diabetic education.

Detailed Description:

Among newly-treated Diabetic Peripheral Neuropathy (DPN) patients, the investigators will compare the systematic collection and feedback of information about patients' treatment experiences on changes in quality of life (intervention group) to newly treated DPN patients in usual care who will receive generic educational messages by phone but no active data collection and feedback (comparator group). The investigators have chosen usual care as the control to evaluate the potential for the intervention to enhance current practice.

Aim 1: Refine and pilot test instruments for collecting the patient-reported data most important for guiding changes in treatment.

Aim 2: Implement a seven-month cluster randomized trial to improve quality of life among patients newly treated for DPN symptoms by collecting data on patient treatment experiences and facilitating evidence-based patient and provider-initiated treatment titration.

Aim 3: Examine patient and physician initiated treatment changes as secondary outcomes in order to inform the development of this type of rapid feedback process for guiding decision making about initial treatment selection among patients with DPN.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02056431

Contacts
Contact: Rosa M. Hippler, MA 510-891-3721 Rosa.M.Hippler@kp.org

Locations
United States, California
Division of Research Kaiser Permanente Recruiting
Oakland, California, United States, 94612
Contact: Andrea Altschuller, PhD    510-891-3560    Andrea.Altschuler@kp.org   
Sponsors and Collaborators
Kaiser Permanente
Patient Centered Outcome Research Institute
Investigators
Principal Investigator: Alyce S. Adams, PhD Kaiser Permanente Northern California
  More Information

No publications provided

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT02056431     History of Changes
Other Study ID Numbers: CE-1304-7250
Study First Received: January 31, 2014
Last Updated: November 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
Diabetes
Neuropathy
Patient-Reported Outcomes

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on November 27, 2014