NCT01867476

Brief Summary

The purpose of this study is to determine the feasibility and accuracy of an automated adherence monitoring system, and to compare the variance between urine and oral fluid riboflavin levels when specimens are obtained 'as usual' and after a one-hour inter specimen interval.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2013

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 4, 2013

Completed
Last Updated

June 4, 2013

Status Verified

May 1, 2013

Enrollment Period

1 month

First QC Date

January 29, 2013

Last Update Submit

May 29, 2013

Conditions

Medication Adherence

Outcome Measures

Primary Outcomes (1)

  • Variance between urine and oral fluid riboflavin levels when specimens are obtained 'as usual' and after a one-hour inter specimen interval

    + 1, 2, 3, 4, 6 hours post dose

Study Arms (1)

Healthy Normals

Other: Automated Adherence Monitoring System

Interventions

Automated Adherence Monitoring SystemOTHER
Healthy Normals

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy Normals

You may qualify if:

  • Male or female, aged 18 to 60
  • Ability to give informed consent.
  • Be willing and able to use the study-provided phone for taking and transmitting capsule photos.

You may not qualify if:

  • Unwilling or unable to use a cell phone.
  • Any medical, psychiatric, or other condition that, in the opinion of the investigator, would preclude safe, consistent, or useful participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Addiction & Pharmacology Research Lab, St. Luke's Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • John Mendelson, MD

    California Pacific Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

January 29, 2013

First Posted

June 4, 2013

Study Start

January 1, 2013

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

June 4, 2013

Record last verified: 2013-05

Locations

US(1)