Trial Outcomes & Findings for Portal-724 MEMS for Medication Adherence Patients Taking HCV Medications (NCT NCT02858050)
NCT ID: NCT02858050
Last Updated: 2023-04-13
Results Overview
Number of Participants with Compliance to Regimen 95% of the Time Due to Portal724-MEMS Service
Recruitment status
COMPLETED
Target enrollment
40 participants
Primary outcome timeframe
1 year
Results posted on
2023-04-13
Participant Flow
Participant milestones
| Measure |
Portal-724 MEMs Cap Real-Time Monitoring
Group 1 will consist of patient taking hepatitis C medicaitons and will have Portal-724 MEMs cap place in their medication bottle and will transmit data in real-time
Portal-724 MEMs Cap
|
Portal-724 MEMs Cap Without Real-Time Monitoring
Group 2 will consist of patient taking hepatitis C medicaitons and will have Portal-724 MEMs cap place in their medication bottle and data will be downloaded at each study visit while taking hepatitis C medications
Portal-724 MEMs Cap
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Portal-724 MEMS for Medication Adherence Patients Taking HCV Medications
Baseline characteristics by cohort
| Measure |
Portal-724 MEMs Cap Real-Time Monitoring
n=20 Participants
Group 1 will consist of patient taking hepatitis C medicaitons and will have Portal-724 MEMs cap place in their medication bottle and will transmit data in real-time
Portal-724 MEMs Cap
|
Portal-724 MEMs Cap Without Real-Time Monitoring
n=20 Participants
Group 2 will consist of patient taking hepatitis C medicaitons and will have Portal-724 MEMs cap place in their medication bottle and data will be downloaded at each study visit while taking hepatitis C medications
Portal-724 MEMs Cap
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Non-Caucasion
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Treatment Naive
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearNumber of Participants with Compliance to Regimen 95% of the Time Due to Portal724-MEMS Service
Outcome measures
| Measure |
Portal-724 MEMs Cap Real-Time Monitoring
n=20 Participants
Group 1 will consist of patient taking hepatitis C medicaitons and will have Portal-724 MEMs cap place in their medication bottle and will transmit data in real-time
Portal-724 MEMs Cap
|
Portal-724 MEMs Cap Without Real-Time Monitoring
n=20 Participants
Group 2 will consist of patient taking hepatitis C medicaitons and will have Portal-724 MEMs cap place in their medication bottle and data will be downloaded at each study visit while taking hepatitis C medications
Portal-724 MEMs Cap
|
|---|---|---|
|
Use of Portal724-MEMS Service on Medication Adherence in the Treatment of Hepatitis C in Patients, Defined as Compliance to Regimen 95% of the Time.
|
19 Participants
|
18 Participants
|
Adverse Events
Portal-724 MEMs Cap Real-Time Monitoring
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Portal-724 MEMs Cap Without Real-Time Monitoring
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 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