Trial · NCT02056431
Balancing Treatment Outcomes and Medication Burden Among Patients With Symptomatic Diabetic Peripheral Neuropathy
NCT02056431, Not applicable, Completed, Kaiser Permanente; results first posted 2018-02-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Balancing Treatment Outcomes and Medication Burden Among Patients With Symptomatic Diabetic Peripheral Neuropathy. Trials, record NCT02056431. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02056431
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Balancing Treatment Outcomes and Medication Burden Among Patients With Symptomatic Diabetic Peripheral Neuropathy
- NCT number
- NCT02056431
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,270 participants, actual
- Lead sponsor
- Kaiser Permanente
- Conditions
- Diabetic Peripheral Neuropathy
- Interventions
- IVR Intervention Group
- First posted
- 2014-02-06
- Last updated
- 2018-06-28
- Results first posted
- 2018-02-12
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Patient Quality of Life at Baseline and 8 Months | Baseline and 8 months | 1179 patients completed the close out survey | units on a scale | MEAN |
| SECONDARY | Number of Participants With Minimally Effective Dose in 12 Months | 12 months | 1179 Patient completed the close out survey | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Patient Quality of Life at Baseline and 8 Months | IVR Intervention Group | Baseline time-point | 0.66 | Standard Deviation 0.10 | units on a scale |
| Change in Patient Quality of Life at Baseline and 8 Months | IVR Control Group | Baseline time-point | 0.65 | Standard Deviation 0.10 | units on a scale |
| Change in Patient Quality of Life at Baseline and 8 Months | IVR Intervention Group | 8 Month time-point | 0.68 | Standard Deviation 0.10 | units on a scale |
| Change in Patient Quality of Life at Baseline and 8 Months | IVR Control Group | 8 Month time-point | 0.68 | Standard Deviation 0.10 | units on a scale |
| Number of Participants With Minimally Effective Dose in 12 Months | IVR Control Group | 299 | Participants | ||
| Number of Participants With Minimally Effective Dose in 12 Months | IVR Intervention Group | 290 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IVR Intervention Group | 604 | |
| Overall Study | STARTED | IVR Control Group | 666 | |
| Overall Study | COMPLETED | IVR Intervention Group | 560 | |
| Overall Study | COMPLETED | IVR Control Group | 619 | |
| Overall Study | NOT COMPLETED | IVR Intervention Group | 44 | |
| Overall Study | NOT COMPLETED | IVR Control Group | 47 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Death | General disorders | IVR Intervention Group | 20 | 604 | 20 |
| serious | Death | General disorders | IVR Control Group | 24 | 666 | 24 |
| serious | Any Hospitalizations Occurring During the Study Period | General disorders | IVR Intervention Group | 118 | 604 | 118 |
| serious | Any Hospitalizations Occurring During the Study Period | General disorders | IVR Control Group | 125 | 666 | 125 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IVR Intervention Group | ||
| Total, all-cause mortality | IVR Control Group | ||
| Total, other adverse events | IVR Intervention Group | 0 | 604 |
| Total, other adverse events | IVR Control Group | 0 | 666 |
| Total, serious adverse events | IVR Intervention Group | 138 | 604 |
| Total, serious adverse events | IVR Control Group | 149 | 666 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| IVR Control Group vs IVR Intervention Group: Number of Participants With Minimally Effective Dose in 12 Months | Trial comparisons |
| IVR Intervention Group vs IVR Control Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02056431
GET https://conductscience.org/api/trials/v1/NCT02056431/registered