Diabetic Peripheral Neuropathy
Conditions
Keywords
Diabetes, Neuropathy, Patient-Reported Outcomes
Brief 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
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.
Interventions
BEHAVIORALIVR 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.
Sponsors
Patient-Centered Outcomes Research Institute
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Quality of Life at Baseline and 8 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Minimally Effective Dose in 12 Months | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
IVR Intervention Group: 595 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. | 604 |
| 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. | 666 |
| Total | 1,270 |
Baseline characteristics
| Characteristic | IVR Intervention Group | IVR Control Group | Total |
|---|---|---|---|
| Age, Continuous | 67.1 years STANDARD_DEVIATION 12 | 67.0 years STANDARD_DEVIATION 11.5 | 67.0 years STANDARD_DEVIATION 11.8 |
| Race/Ethnicity, Customized American Indian/Alaskan Native | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 54 Participants | 50 Participants | 104 Participants |
| Race/Ethnicity, Customized Black or African American | 79 Participants | 88 Participants | 167 Participants |
| Race/Ethnicity, Customized Hispanic | 115 Participants | 133 Participants | 248 Participants |
| Race/Ethnicity, Customized More than One Race | 3 Participants | 4 Participants | 7 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 2 Participants | 7 Participants | 9 Participants |
| Race/Ethnicity, Customized Unknown | 7 Participants | 8 Participants | 15 Participants |
| Race/Ethnicity, Customized White | 343 Participants | 375 Participants | 718 Participants |
| Region of Enrollment United States | 604 Participants | 666 Participants | 1270 Participants |
| Sex: Female, Male Female | 329 Participants | 349 Participants | 678 Participants |
| Sex: Female, Male Male | 275 Participants | 317 Participants | 592 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 604 | 0 / 666 |
| serious Total, serious adverse events | 138 / 604 | 149 / 666 |
Outcome results
Primary
Change in Patient Quality of Life at 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.
Time frame: Baseline and 8 months
Population: 1179 patients completed the close out survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IVR Intervention Group | Change in Patient Quality of Life at Baseline and 8 Months | Baseline time-point | 0.66 units on a scale | Standard Deviation 0.1 |
| IVR Intervention Group | Change in Patient Quality of Life at Baseline and 8 Months | 8 Month time-point | 0.68 units on a scale | Standard Deviation 0.1 |
| IVR Control Group | Change in Patient Quality of Life at Baseline and 8 Months | Baseline time-point | 0.65 units on a scale | Standard Deviation 0.1 |
| IVR Control Group | Change in Patient Quality of Life at Baseline and 8 Months | 8 Month time-point | 0.68 units on a scale | Standard Deviation 0.1 |
Secondary
Number of Participants With Minimally Effective Dose in 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).
Time frame: 12 months
Population: 1179 Patient completed the close out survey
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IVR Intervention Group | Number of Participants With Minimally Effective Dose in 12 Months | 299 Participants |
| IVR Control Group | Number of Participants With Minimally Effective Dose in 12 Months | 290 Participants |