Trial Outcomes & Findings for Smart Capsule for Automatic Adherence Monitoring (NCT NCT02344238)
NCT ID: NCT02344238
Last Updated: 2018-11-08
Results Overview
The primary outcome will be medication adherence as measured by percentage of doses taken among groups.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
30 days
Results posted on
2018-11-08
Participant Flow
Participant milestones
| Measure |
Standard Capsules
Compliance measured by self-report and riboflavin measurement.
Riboflavin: 50mg
|
ID Capsules Without Prompts
Compliance measured by self-report, riboflavin measurement, and data collected by the ID Cap.
ID Cap: Capsule-encased computer chip
Riboflavin: 50mg
|
ID Capsules With Prompts
Compliance measured by self-report, riboflavin measurement, and data collected by the ID Cap. This arm will also receive prompts (reminder calls and/or text messages) to ingest the study medication if a signal is not sent to the study team within one hour of the scheduled medication administration time.
ID Cap: Capsule-encased computer chip
Riboflavin: 50mg
Prompts: Reminder calls and/or text messages to ingest the study medication if a signal is not sent to the study team within one hour of the scheduled medication administration time.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Smart Capsule for Automatic Adherence Monitoring
Baseline characteristics by cohort
| Measure |
Standard Capsules
n=20 Participants
Compliance measured by self-report and riboflavin measurement.
Riboflavin: 50mg
|
ID Capsules Without Prompts
n=20 Participants
Compliance measured by self-report, riboflavin measurement, and data collected by the ID Cap.
ID Cap: Capsule-encased computer chip
Riboflavin: 50mg
|
ID Capsules With Prompts
n=20 Participants
Compliance measured by self-report, riboflavin measurement, and data collected by the ID Cap. This arm will also receive prompts (reminder calls and/or text messages) to ingest the study medication if a signal is not sent to the study team within one hour of the scheduled medication administration time.
ID Cap: Capsule-encased computer chip
Riboflavin: 50mg
Prompts: Reminder calls and/or text messages to ingest the study medication if a signal is not sent to the study team within one hour of the scheduled medication administration time.
|
Total
n=60 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
60 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 30 daysThe primary outcome will be medication adherence as measured by percentage of doses taken among groups.
Outcome measures
| Measure |
Standard Capsules
n=20 Participants
Received standard capsules, with adherence measured by self-report, pill count and riboflavin measurement.
Riboflavin: 50mg
|
ID Capsules Without Prompts
n=20 Participants
Received ID capsules, with adherence measured by self-report, pill count, riboflavin measurement, and data collected by the ID Cap.
ID Cap: Capsule containing ingestible sensor
Riboflavin: 50mg
|
ID Capsules With Prompts
n=20 Participants
Received ID capsules, with adherence measured by self-report, pill count, riboflavin measurement, and data collected by the ID Cap. This arm will also receive prompts (reminder calls and/or text messages) to ingest the study medication if a signal is not sent to the study team within one hour of the scheduled medication administration time.
ID Cap: Capsule containing ingestible sensor
Riboflavin: 50mg
Prompts: Reminder calls and/or text messages to ingest the study medication if a signal is not sent to the study team within one hour of the scheduled medication administration time.
|
|---|---|---|---|
|
Medication Adherence
|
88.1 percentage of doses taken (pill count)
Interval 82.4 to 93.7
|
96.6 percentage of doses taken (pill count)
Interval 93.0 to 100.0
|
94.4 percentage of doses taken (pill count)
Interval 89.5 to 99.4
|
SECONDARY outcome
Timeframe: 30 daysA secondary outcome will be safety and tolerability of ingestion of the ID Cap as measured by number of participants reporting adverse events in Group 1 who received standard capsules (no ID technology, study Arm 1) and Group 2 who received ID-Capsules (study Arms 2 and 3).
Outcome measures
| Measure |
Standard Capsules
n=20 Participants
Received standard capsules, with adherence measured by self-report, pill count and riboflavin measurement.
Riboflavin: 50mg
|
ID Capsules Without Prompts
n=40 Participants
Received ID capsules, with adherence measured by self-report, pill count, riboflavin measurement, and data collected by the ID Cap.
ID Cap: Capsule containing ingestible sensor
Riboflavin: 50mg
|
ID Capsules With Prompts
Received ID capsules, with adherence measured by self-report, pill count, riboflavin measurement, and data collected by the ID Cap. This arm will also receive prompts (reminder calls and/or text messages) to ingest the study medication if a signal is not sent to the study team within one hour of the scheduled medication administration time.
ID Cap: Capsule containing ingestible sensor
Riboflavin: 50mg
Prompts: Reminder calls and/or text messages to ingest the study medication if a signal is not sent to the study team within one hour of the scheduled medication administration time.
|
|---|---|---|---|
|
Number of Participants Reporting Adverse Events
|
10 Participants
|
20 Participants
|
—
|
Adverse Events
Standard Capsules
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
ID Capsules
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Capsules
n=20 participants at risk
Compliance measured by self-report, pill count and riboflavin measurement (study Arm 1)
Riboflavin: 50mg
|
ID Capsules
n=40 participants at risk
Compliance measured by self-report, pill count, riboflavin measurement, and data collected by the ID Cap (study Arms 2 and 3).
ID Cap: Capsule-encased computer chip
Riboflavin: 50mg
|
|---|---|---|
|
General disorders
Headache
|
5.0%
1/20 • Number of events 2
|
5.0%
2/40 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cold
|
30.0%
6/20 • Number of events 6
|
27.5%
11/40 • Number of events 12
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20
|
2.5%
1/40 • Number of events 1
|
|
Gastrointestinal disorders
Other GI
|
5.0%
1/20 • Number of events 1
|
5.0%
2/40 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
5.0%
1/20 • Number of events 1
|
2.5%
1/40 • Number of events 1
|
|
General disorders
Allergies
|
10.0%
2/20 • Number of events 2
|
5.0%
2/40 • Number of events 2
|
|
General disorders
Other
|
10.0%
2/20 • Number of events 3
|
15.0%
6/40 • Number of events 7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place