Trial Outcomes & Findings for Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady) (NCT NCT01643707)
NCT ID: NCT01643707
Last Updated: 2021-09-17
Results Overview
The absolute change in the proportion of subjects diagnosed with SND before and after intervention
Recruitment status
COMPLETED
Target enrollment
1342 participants
Primary outcome timeframe
Up to 1 year post enrollment
Results posted on
2021-09-17
Participant Flow
Phase I served as a control period during which physicians assessed and treated subjects per their site's standard care practice. In Phase 2, investigators completed an educational workshop, were given access to the IMPROVE Brady toolkit and encouraged to adapt tools from this kit to create a practice-specific process improvement implementation.
Participant milestones
| Measure |
Phase I
Phase I served as a control period during which physicians assessed and treated subjects per their site's standard care practice.
|
Phase II
In Phase 2, investigators completed an educational workshop, were given access to the IMPROVE Brady toolkit and encouraged to adapt tools from this kit to create a practice-specific process improvement implementation.
|
|---|---|---|
|
Overall Study
STARTED
|
858
|
484
|
|
Overall Study
COMPLETED
|
823
|
470
|
|
Overall Study
NOT COMPLETED
|
35
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Registry to Improve the Adoption of Consensus Treatment Guidelines (IMPROVE Brady)
Baseline characteristics by cohort
| Measure |
Phase I
n=823 Participants
Phase I served as a control period during which physicians assessed and treated subjects per their site's standard care practice. Phase I of the study was to understand the current pathways at hospital for SND patient screening \& management.
|
Phase II
n=470 Participants
In Phase II, investigators completed an educational workshop, were given access to the IMPROVE Brady toolkit and encouraged to adapt tools from this kit to create a practice-specific process improvement implementation. The toolkit included: a physician training seminar, a diagnostic algorithm, patient education materials, a list of available therapy options, and/or information regarding the benefits and risks associated with the therapy options.
|
Total
n=1293 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.0 years
STANDARD_DEVIATION 16.0 • n=99 Participants
|
57.9 years
STANDARD_DEVIATION 14.9 • n=107 Participants
|
59.3 years
STANDARD_DEVIATION 15.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
277 Participants
n=99 Participants
|
128 Participants
n=107 Participants
|
405 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
546 Participants
n=99 Participants
|
342 Participants
n=107 Participants
|
888 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnic Origin · Subject/Physician Chose not to provide information
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnic Origin · Not reportable per local laws or regulations
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnic Origin · American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnic Origin · Asian
|
59 Participants
n=99 Participants
|
106 Participants
n=107 Participants
|
165 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnic Origin · Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnic Origin · Hispanic or Latino
|
163 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
163 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnic Origin · Native Hawaiian or Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnic Origin · White or Caucasian
|
142 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
142 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnic Origin · Indian
|
444 Participants
n=99 Participants
|
345 Participants
n=107 Participants
|
789 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnic Origin · Two or More Races
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnic Origin · Other
|
10 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnic Origin · Unknown/Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 1 year post enrollmentPopulation: Only sites in South Asia participated in both Phase 1 and Phase 2, as such those subjects were included for objective analysis.
The absolute change in the proportion of subjects diagnosed with SND before and after intervention
Outcome measures
| Measure |
Phase 1
n=508 Participants
Control subjects in the South Asia Region.
|
Phase 2
n=470 Participants
Treatment subjects in the South Asia Region
|
|---|---|---|
|
The Absolute Change in the Proportion of Subjects Diagnosed With SND Before and After Intervention
|
368 Participants
|
409 Participants
|
PRIMARY outcome
Timeframe: Up to 6 months post diagnosisPopulation: Subjects with an SND diagnosis
Outcome measure applies to subjects that receive a SND diagnosis
Outcome measures
| Measure |
Phase 1
n=368 Participants
Control subjects in the South Asia Region.
|
Phase 2
n=409 Participants
Treatment subjects in the South Asia Region
|
|---|---|---|
|
The Absolute Change in the Proportion of Subjects Receiving Indicated Therapy Before and After Intervention
|
63 Participants
|
130 Participants
|
SECONDARY outcome
Timeframe: SND diagnosis assessed at 6 and 12 months of follow-up from enrollment until resulting IPG therapyPopulation: Only subjects diagnosed in each phase with SND.
Enrolled subjects only with an SND diagnosis were reassessed at 6 and 12 months post enrollment were reassessed for IPG therapy.
Outcome measures
| Measure |
Phase 1
n=368 Participants
Control subjects in the South Asia Region.
|
Phase 2
n=409 Participants
Treatment subjects in the South Asia Region
|
|---|---|---|
|
The Proportion of Phase I Subjects Diagnosed With SND and the Number of Diagnoses That Result in Indicated Therapy
Subjects Diagnosed
|
368 Participants
|
409 Participants
|
|
The Proportion of Phase I Subjects Diagnosed With SND and the Number of Diagnoses That Result in Indicated Therapy
Subjects Implanted
|
63 Participants
|
130 Participants
|
SECONDARY outcome
Timeframe: From date of enrollment until date of SND diagnosis, assessed up to 60 monthsTime to diagnosis days (date of diagnosis - date of enrollment)
Outcome measures
| Measure |
Phase 1
n=368 Participants
Control subjects in the South Asia Region.
|
Phase 2
n=409 Participants
Treatment subjects in the South Asia Region
|
|---|---|---|
|
Change in Time to Diagnosis of SND Before and After Intervention
4-5 Months
|
2 Participants
|
3 Participants
|
|
Change in Time to Diagnosis of SND Before and After Intervention
5-6 Months
|
2 Participants
|
2 Participants
|
|
Change in Time to Diagnosis of SND Before and After Intervention
Greater than 6 Months
|
47 Participants
|
4 Participants
|
|
Change in Time to Diagnosis of SND Before and After Intervention
0 Months (or Prior to Enrollment)
|
126 Participants
|
232 Participants
|
|
Change in Time to Diagnosis of SND Before and After Intervention
Prior to 1 Month
|
168 Participants
|
156 Participants
|
|
Change in Time to Diagnosis of SND Before and After Intervention
1-2 Months
|
10 Participants
|
7 Participants
|
|
Change in Time to Diagnosis of SND Before and After Intervention
2-3 Months
|
7 Participants
|
4 Participants
|
|
Change in Time to Diagnosis of SND Before and After Intervention
3-4 Months
|
6 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From date of SND diagnosis until date of therapy, assessed up to 6 monthsTime to implant in days (date of implant - date of diagnosis)
Outcome measures
| Measure |
Phase 1
n=63 Participants
Control subjects in the South Asia Region.
|
Phase 2
n=130 Participants
Treatment subjects in the South Asia Region
|
|---|---|---|
|
Change in Time to Receiving an Indicated IPG Device for Subjects Diagnosed With SND Before and After Intervention
0 Months or Prior to Implant
|
22 Participants
|
52 Participants
|
|
Change in Time to Receiving an Indicated IPG Device for Subjects Diagnosed With SND Before and After Intervention
1-2 Months
|
1 Participants
|
0 Participants
|
|
Change in Time to Receiving an Indicated IPG Device for Subjects Diagnosed With SND Before and After Intervention
2-3 Months
|
0 Participants
|
2 Participants
|
|
Change in Time to Receiving an Indicated IPG Device for Subjects Diagnosed With SND Before and After Intervention
Prior to 1 Month
|
37 Participants
|
74 Participants
|
|
Change in Time to Receiving an Indicated IPG Device for Subjects Diagnosed With SND Before and After Intervention
Greater than 3 Months
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: between implant visit and 6 months post-implantPopulation: Only subjects receiving a Medtronic device with both Implant and 6 Month data were included
The difference in quality of life was assessed using the SF-12 survey, with higher numbers indicating a better quality of life for the patient. The possible physical score ranges are between 24.0 and 56.6. The possible mental score ranges are between 19.1 and 60.8. Only the difference over time was reported.
Outcome measures
| Measure |
Phase 1
n=69 Participants
Control subjects in the South Asia Region.
|
Phase 2
Treatment subjects in the South Asia Region
|
|---|---|---|
|
Difference in QoL Between Implant Visit and 6 Months Post-implant
SF-12 Physical Component
|
11.7 difference of score on the SF-12 scale
Standard Deviation 8.1
|
—
|
|
Difference in QoL Between Implant Visit and 6 Months Post-implant
SF-12 Mental Component
|
10.2 difference of score on the SF-12 scale
Standard Deviation 10.6
|
—
|
SECONDARY outcome
Timeframe: between implant visit and 6 months post-implantPopulation: Only subjects receiving a Medtronic device with both Implant and 6 Month data were included
The difference in caregiver burden was assessed using a Zarit survey, with lower numbers indicating a decreased burden or a better outcome for the caregiver. The possible range of scores was between 0 and 88. Only the difference in scores over time were reported.
Outcome measures
| Measure |
Phase 1
n=69 Participants
Control subjects in the South Asia Region.
|
Phase 2
Treatment subjects in the South Asia Region
|
|---|---|---|
|
Change in Zarit Quality of Life (QOL) Between Implant Visit and 6 Months Post-implant
|
-14.7 change in score on Zarit QoL scale
Standard Deviation 15.7
|
—
|
Adverse Events
Phase I
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Phase II
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60