Trial Outcomes & Findings for Balancing Treatment Outcomes and Medication Burden Among Patients With Symptomatic Diabetic Peripheral Neuropathy (NCT NCT02056431)
NCT ID: NCT02056431
Last Updated: 2018-06-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1270 participants
Primary outcome timeframe
Baseline and 8 months
Results posted on
2018-06-28
Participant Flow
Participant milestones
| Measure |
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 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.
|
|---|---|---|
|
Overall Study
STARTED
|
604
|
666
|
|
Overall Study
COMPLETED
|
560
|
619
|
|
Overall Study
NOT COMPLETED
|
44
|
47
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Balancing Treatment Outcomes and Medication Burden Among Patients With Symptomatic Diabetic Peripheral Neuropathy
Baseline characteristics by cohort
| Measure |
IVR Intervention Group
n=604 Participants
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.
|
IVR Control Group
n=666 Participants
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.
|
Total
n=1270 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.1 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
67.0 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
67.0 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
329 Participants
n=5 Participants
|
349 Participants
n=7 Participants
|
678 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
275 Participants
n=5 Participants
|
317 Participants
n=7 Participants
|
592 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
54 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
79 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
343 Participants
n=5 Participants
|
375 Participants
n=7 Participants
|
718 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than One Race
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
115 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
248 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
604 Participants
n=5 Participants
|
666 Participants
n=7 Participants
|
1270 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 8 monthsPopulation: 1179 patients completed the close out survey
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.
Outcome measures
| Measure |
IVR Intervention Group
n=561 Participants
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 Control Group
n=618 Participants
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.
|
|---|---|---|
|
Change in Patient Quality of Life at Baseline and 8 Months
8 Month time-point
|
0.68 units on a scale
Standard Deviation 0.10
|
0.68 units on a scale
Standard Deviation 0.10
|
|
Change in Patient Quality of Life at Baseline and 8 Months
Baseline time-point
|
0.66 units on a scale
Standard Deviation 0.10
|
0.65 units on a scale
Standard Deviation 0.10
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 1179 Patient completed the close out survey
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).
Outcome measures
| Measure |
IVR Intervention Group
n=618 Participants
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 Control Group
n=561 Participants
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.
|
|---|---|---|
|
Number of Participants With Minimally Effective Dose in 12 Months
|
299 Participants
|
290 Participants
|
Adverse Events
IVR Intervention Group
Serious events: 138 serious events
Other events: 0 other events
Deaths: 0 deaths
IVR Control Group
Serious events: 149 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IVR Intervention Group
n=604 participants at risk
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: 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 Control Group
n=666 participants at risk
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.
|
|---|---|---|
|
General disorders
Death
|
3.3%
20/604 • Number of events 20 • Adverse event data were collected for each participant from the time of enrollment through 8 months.
Given that this is a low risk study, we do not anticipate that any of the adverse events are associated with the intervention itself. We created an algorithm to extract information on deaths among participants from the electronic medical record every 6 months and reported these to the independent safety monitor.
|
3.6%
24/666 • Number of events 24 • Adverse event data were collected for each participant from the time of enrollment through 8 months.
Given that this is a low risk study, we do not anticipate that any of the adverse events are associated with the intervention itself. We created an algorithm to extract information on deaths among participants from the electronic medical record every 6 months and reported these to the independent safety monitor.
|
|
General disorders
Any Hospitalizations Occurring During the Study Period
|
19.5%
118/604 • Number of events 118 • Adverse event data were collected for each participant from the time of enrollment through 8 months.
Given that this is a low risk study, we do not anticipate that any of the adverse events are associated with the intervention itself. We created an algorithm to extract information on deaths among participants from the electronic medical record every 6 months and reported these to the independent safety monitor.
|
18.8%
125/666 • Number of events 125 • Adverse event data were collected for each participant from the time of enrollment through 8 months.
Given that this is a low risk study, we do not anticipate that any of the adverse events are associated with the intervention itself. We created an algorithm to extract information on deaths among participants from the electronic medical record every 6 months and reported these to the independent safety monitor.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Alyce S. Adams
Kaiser Permanente Division of Research
Phone: 510-891-5921
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place