Trial Outcomes & Findings for Multivitamin Adherence Following Bariatric Surgery (NCT NCT02124889)
NCT ID: NCT02124889
Last Updated: 2019-05-31
Results Overview
Percent of anticipated number of doses the patient has taken, as recorded by a Medication Event Monitoring System (MEMS) cap.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
50 days
Results posted on
2019-05-31
Participant Flow
Participant milestones
| Measure |
Weekly Surveys
Subjects will take the multivitamin, and will also receive weekly Internet surveys asking them questions about the multivitamin treatment.
Weekly Internet surveys: Subjects in this arm will receive weekly Internet surveys asking them how their treatment is working, how often they took the medication, and how easy it was to use the medication.
|
No Survey
Group will only get multivitamin - no weekly survey
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Weekly Surveys
n=12 Participants
Subjects will take the multivitamin, and will also receive weekly Internet surveys asking them questions about the multivitamin treatment.
Weekly Internet surveys: Subjects in this arm will receive weekly Internet surveys asking them how their treatment is working, how often they took the medication, and how easy it was to use the medication.
|
No Survey - Control
n=12 Participants
Subjects will take the multivitamin but will not receive surveys.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
24 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=12 Participants
|
9 Participants
n=12 Participants
|
19 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
5 Participants
n=24 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
12 participants
n=12 Participants
|
12 participants
n=12 Participants
|
24 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 50 daysPercent of anticipated number of doses the patient has taken, as recorded by a Medication Event Monitoring System (MEMS) cap.
Outcome measures
| Measure |
Weekly Surveys
n=12 Participants
Subjects will take the multivitamin, and will also receive weekly Internet surveys asking them questions about the multivitamin treatment.
Weekly Internet surveys: Subjects in this arm will receive weekly Internet surveys asking them how their treatment is working, how often they took the medication, and how easy it was to use the medication.
|
No Survey
n=12 Participants
Subjects will take the multivitamin.
|
|---|---|---|
|
Adherence to Multivitamin
|
32.9 percentage of doses taken
Standard Error 5.93
|
34.9 percentage of doses taken
Standard Error 5.91
|
Adverse Events
Weekly Surveys
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Survey - Control
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