Balancing Treatment Outcomes and Medication Burden Among Patients With Symptomatic Diabetic Peripheral Neuropathy
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| ClinicalTrials.gov Identifier: NCT02056431 |
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Recruitment Status :
Completed
First Posted : February 6, 2014
Results First Posted : February 12, 2018
Last Update Posted : June 28, 2018
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetic Peripheral Neuropathy | Behavioral: IVR Intervention Group | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1270 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Supportive Care |
| Official Title: | Balancing Treatment Outcomes and Medication Burden Among Patients With Symptomatic Diabetic Peripheral Neuropathy |
| Study Start Date : | October 2014 |
| Actual Primary Completion Date : | July 2016 |
| Actual Study Completion Date : | September 2016 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: IVR Intervention Group
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.
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Behavioral: IVR Intervention Group
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. |
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No Intervention: IVR Control Group
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.
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- Change in Patient Quality of Life at Baseline and 8 Months [ Time Frame: Baseline and 8 months ]The primary outcome measure is change in quality of life from baseline at eight months following study entry. We calculated the EuroQOL (EQ-5D) from the Global Health Scale, a 10-item Patient-Reported Outcomes Measurement Information System measure developed and validated in patients with neuropathy as part of the Quality of Life in Neurological Disorders Measures. The range for EQ-5D is 0-1, with "0" being the worst and "1" being the best.
- Number of Participants With Minimally Effective Dose in 12 Months [ Time Frame: 12 months ]Count of patients who ever received a minimally effective dose of the medications they started on during the 12 months following treatment start (measured post only).
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056431
| United States, California | |
| Division of Research Kaiser Permanente | |
| Oakland, California, United States, 94612 | |
| Principal Investigator: | Alyce S. Adams, PhD | Kaiser Permanente |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Kaiser Permanente |
| ClinicalTrials.gov Identifier: | NCT02056431 |
| Other Study ID Numbers: |
CE-1304-7250 |
| First Posted: | February 6, 2014 Key Record Dates |
| Results First Posted: | February 12, 2018 |
| Last Update Posted: | June 28, 2018 |
| Last Verified: | May 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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Diabetes Neuropathy Patient-Reported Outcomes |
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Peripheral Nervous System Diseases Diabetic Neuropathies Neuromuscular Diseases Nervous System Diseases |
Diabetes Complications Diabetes Mellitus Endocrine System Diseases |