Trial Outcomes & Findings for Assessing the Effectiveness and Safety of the ID-Cap System for Medication Monitoring and Adherence (NCT NCT02344251)

NCT ID: NCT02344251

Last Updated: 2018-06-01

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: 40 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2018-06-01

Participant Flow

Participant milestones

Measure	MEMS Track Cap Compliance measured by MEMS Cap, riboflavin and self-report. MEMS Cap: MEMS Track Cap records when the medication bottle is opened and closed Riboflavin: 50 mg	ID Cap Tag Compliance measured by riboflavin, self-report, and ID-Cap technology. ID-Cap: ID-Cap Tag is an ingestible medical device for detecting the presence of an ingested capsule inside the gastrointestinal (GI) tract. Riboflavin: 50 mg
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

Assessing the Effectiveness and Safety of the ID-Cap System for Medication Monitoring and Adherence

Baseline characteristics by cohort

Measure	MEMS Track Cap n=20 Participants Compliance measured by MEMS Cap MEMS Cap: MEMS Track Cap records when the medication bottle is opened and closed	ID Cap Tag n=20 Participants Compliance measured by ID-Cap technology ID-Cap: ID-Cap Tag is an ingestible medical device for detecting the presence of an ingested capsule inside the gastrointestinal (GI) tract.	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	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

The primary outcome will be medication adherence as measured by percentage of doses taken among groups.

Outcome measures

Measure	MEMS Track Cap n=20 Participants Adherence measured by MEMS Cap MEMS Cap: MEMS Track Cap records when the medication bottle is opened and closed	ID Cap n=20 Participants Adherence measured by ID-Cap technology. ID-Capsule: ID-Capsule is an ingestible medical device for detecting the presence of an ingested capsule inside the gastrointestinal (GI) tract.
Medication Adherence	94.8 percentage of doses taken Interval 92.2 to 97.3	82.8 percentage of doses taken Interval 76.4 to 89.3

SECONDARY outcome

Timeframe: 30 days

A secondary outcome will be safety assessment as measured by the percentage of participants reporting adverse events.

Outcome measures

Measure	MEMS Track Cap n=20 Participants Adherence measured by MEMS Cap MEMS Cap: MEMS Track Cap records when the medication bottle is opened and closed	ID Cap n=20 Participants Adherence measured by ID-Cap technology. ID-Capsule: ID-Capsule is an ingestible medical device for detecting the presence of an ingested capsule inside the gastrointestinal (GI) tract.
Safety Assessment: Rates of Adverse Events Reported	25 percentage of participants reporting AEs	15 percentage of participants reporting AEs

Adverse Events

MEMS Track Cap

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

ID Cap Tag

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	MEMS Track Cap n=20 participants at risk Compliance measured by MEMS Cap MEMS Cap: MEMS Track Cap records when the medication bottle is opened and closed	ID Cap Tag n=20 participants at risk Compliance measured by ID-Cap technology. ID-Cap: ID-Cap Tag is an ingestible medical device for detecting the presence of an ingested capsule inside the gastrointestinal (GI) tract.
Nervous system disorders Headache	5.0% 1/20 • Number of events 1 • 4 week medication period	5.0% 1/20 • Number of events 1 • 4 week medication period
Respiratory, thoracic and mediastinal disorders Cold	5.0% 1/20 • Number of events 1 • 4 week medication period	10.0% 2/20 • Number of events 2 • 4 week medication period
Gastrointestinal disorders Food poisoning	5.0% 1/20 • Number of events 1 • 4 week medication period	0.00% 0/20 • 4 week medication period
Infections and infestations Ringworm	5.0% 1/20 • Number of events 1 • 4 week medication period	0.00% 0/20 • 4 week medication period
Renal and urinary disorders Increased urination	5.0% 1/20 • Number of events 1 • 4 week medication period	0.00% 0/20 • 4 week medication period
General disorders weight gain	5.0% 1/20 • Number of events 1 • 4 week medication period	0.00% 0/20 • 4 week medication period

Additional Information

Dr. Aimee McRae-Clark

MUSC

Email: mcraeal@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place