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Unobtrusive Sensing of Medication Intake ("USE-MI") (USE-MI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03571022
Recruitment Status : Recruiting
First Posted : June 27, 2018
Last Update Posted : January 14, 2020
Sponsor:
Collaborators:
University of Massachusetts, Amherst
University of Washington
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Swedish Medical Center

Brief Summary:
The purpose of this study is to test the USE-MI system hardware and software to see if it can accurately measure when subjects take their HIV-related medications and help them remember to take these medications. With the use of a smartwatch and smartphone "app", investigators hope to be able to monitor medication adherence in real-time and send subjects electronic reminders when they may have forgotten to take their medication.

Condition or disease Intervention/treatment Phase
Medication Adherence Behavioral: USE-MI System Not Applicable

Detailed Description:

Human immunodeficiency virus (HIV) treatment is most likely to be successful when patients are committed to taking their medications as prescribed (medication adherence). For maximum benefit, researchers found that patients receiving antiretroviral therapy (ART) to treat HIV infection and pre-exposure prophylaxis (PrEP) to prevent HIV infection have need consistent, high levels of adherence for maximum benefit. However, some patients struggle to take their HIV-related medications regularly and that can lead to losing on the benefits the medication can provide - either suppressing the HIV infection so people do not get sick from it or transmit it, or failing to prevent infection when someone is exposed.

Objectives: Conduct an evaluation of USE-MI to assess accuracy, robustness, acceptability of the system.

All subjects will continue to take their ART or PrEP medication as prescribed by their regular doctor. The USE-MI system is being developed as a behavioral intervention to enhance medication adherence. In the pilot phase, the investigators plan to enroll 10 subjects to use the USE-MI system for 1 month to get initial feedback about the system. In the second phase, up to 50 subjects will begin using the USE-MI for up to 6 months to assess accuracy, robustness and acceptability of the system.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Unobtrusive Sensing of Medication Intake ("USE-MI")
Actual Study Start Date : January 8, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: USE-MI System
Immediate use of the USE-MI smartwatch and smartphone app.
Behavioral: USE-MI System

Pilot Phase: 10 subjects will continue with their ART or PrEP medication and begin using the USE-MI system. Subjects will wear a smartwatch every day to monitor their pill taking activity for 1 month and receive weekly phone calls to obtain feedback on the system. During the first call, subjects will respond to 2 questionnaires about how they are taking their daily ART or PrEP pill(s).

Second Phase: Up to 50 subjects will continue with their ART or PrEP medication and begin using the USE-MI system. Subjects will wear a smartwatch every day to monitor their pill taking activity for up to 6 months. During their first month, subjects will receive weekly phone calls to obtain feedback on the system. During the first call, subjects will respond to 2 questionnaires about how they are taking their daily ART or PrEP pill(s). Subjects will come to the research office every month to complete a brief questionnaire about how they are taking their daily ART or PrEP pill(s).





Primary Outcome Measures :
  1. System Acceptability [ Time Frame: 6 Months ]
    Evaluate the use of the USE-MI system after 6 months of follow-up. At each monthly visit, subjects will complete a questionnaire about their medication-taking habits, plus the study staff will perform a manual count of their pills. Subjects will be asked for feedback about improving the system, whether they found it helpful, and whether they would be willing to continue to use such a system


Secondary Outcome Measures :
  1. Accuracy of Capture of Pill-Taking by USE-MI [ Time Frame: 6 Months ]
    Compare the pill count using the USE-MI system versus the study staff manually counting at each monthly visit.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Either a) have an HIV infection and are taking ART, or b) risk factors for contracting HIV infection and are taking PrEP
  • Taking their medications from pill bottles, or other containers that the USE-MI system can monitor properly
  • Reasonable proficiency in English
  • Able to come to the research office for monthly follow-up visits

Exclusion Criteria:

  • Not responsible for taking their own HIV medications (e.g. residing in a supervised setting where their medications are administered to them)
  • Taking medications using a method that the USE-MI system cannot monitor properly
  • Lacking proficiency in English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03571022


Contacts
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Contact: Julie Wallick 206-215-3986 julie.wallick@swedish.org

Locations
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United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122
Contact: Julie Wallick    206-215-3986    julie.wallick@swedish.org   
Sponsors and Collaborators
Swedish Medical Center
University of Massachusetts, Amherst
University of Washington
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Barry Saver, MD Swedish Medical Center
Principal Investigator: Jenna Marquard, PhD University of Massachusetts, Amherst

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Responsible Party: Swedish Medical Center
ClinicalTrials.gov Identifier: NCT03571022    
Other Study ID Numbers: SWD5984S-16
5R01MH109319 ( U.S. NIH Grant/Contract )
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No