Trial Outcomes & Findings for An Evidence Based Delivery Model of Care for Newly Implanted Adult CI Recipients (NCT NCT03904420)
NCT ID: NCT03904420
Last Updated: 2020-10-29
Results Overview
Change in the overall number of minutes of cochlear implant appointments over the first 6 months post activation in the new model (Group A) compared to the traditional model (Group B).
TERMINATED
NA
4 participants
6 months post activation
2020-10-29
Participant Flow
Participant milestones
| Measure |
Group A - New Model
Standardized programming and testing method
Clinical Education and Treatment Model: Patients will have self directed equipment education and standardized programming approaches
|
Group B - Traditional Model
Traditional clinical model which is not standardized across clinical sites
Traditional Model: Standard clinical practice and education
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Group A - New Model
Standardized programming and testing method
Clinical Education and Treatment Model: Patients will have self directed equipment education and standardized programming approaches
|
Group B - Traditional Model
Traditional clinical model which is not standardized across clinical sites
Traditional Model: Standard clinical practice and education
|
|---|---|---|
|
Overall Study
Study terminated
|
2
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group A - New Model
n=2 Participants
Standardized programming and testing method
Clinical Education and Treatment Model: Patients will have self directed equipment education and standardized programming approaches
|
Group B - Traditional Model
n=2 Participants
Traditional clinical model which is not standardized across clinical sites
Traditional Model: Standard clinical practice and education
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=4 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
2 participants
n=2 Participants
|
2 participants
n=2 Participants
|
4 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 months post activationPopulation: No subjects completed all required visits and data for primary endpoints were not collected due to study termination shortly after execution commenced.
Change in the overall number of minutes of cochlear implant appointments over the first 6 months post activation in the new model (Group A) compared to the traditional model (Group B).
Outcome measures
Outcome data not reported
Adverse Events
Group A - New Model
Group B - Traditional Model
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 The disclosure restriction on the PIs, no data was to be published prior to sponsor publishing. However, an agreement was in place with one site to provide presentation at upcoming conference for a poster presentation.
- Publication restrictions are in place
Restriction type: OTHER