Way to Cure HCV Adherence
Status: | Active, not recruiting |
---|---|
Conditions: | Hepatitis, Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 50 - Any |
Updated: | 3/8/2019 |
Start Date: | June 2015 |
End Date: | July 2019 |
Way to Cure: Developing Effective Strategies to Promote Adherence to Hepatitis C Therapy Among Older Adults
This is a 3-arm, multi-center, patient-randomized, field evaluation of the "Way to Cure"
behavioral interventions on medication adherence in HCV.
behavioral interventions on medication adherence in HCV.
This 3-arm trial will field test the efficacy of "Way to Cure" intervention on medication
adherence in Hepatitis C for 12 weeks. As part of routine clinical care all patients will
receive medication counseling regarding proper use and side effects by trained nurses or
pharmacists depending on the clinical site.
Arm 1: Control (n=20) - Monitoring pill box will be set into "quiet mode". This mode sends
daily adherence data to the Way to Health platform each time the participant opens the pill
bottle, however, does not remind the participant to take the medication. In the event no
electronic signal is received by the platform for 96 hours, the RA will call the participant
to assess any usability or connectivity issues.
Arm 2: Intervention - Reminders/Feedback (n=20) - Patients will receive tailored text message
reminders to take the medication if in case the interval from last box opening is >30 hours
(greater than 6 hours overdue). Patients will receive weekly text messages with summary
cumulative adherence scores.
Arm 3: Intervention - Reminders/Feedback and Financial Incentives (n=20) - In addition to
reminders with missed doses and weekly adherence feedback, patients in this arm will be
eligible to receive a financial incentive each week they demonstrate perfect >85% adherence.
The weekly adherence feedback message will also alert patients whether they earned the
incentive for the past week.
adherence in Hepatitis C for 12 weeks. As part of routine clinical care all patients will
receive medication counseling regarding proper use and side effects by trained nurses or
pharmacists depending on the clinical site.
Arm 1: Control (n=20) - Monitoring pill box will be set into "quiet mode". This mode sends
daily adherence data to the Way to Health platform each time the participant opens the pill
bottle, however, does not remind the participant to take the medication. In the event no
electronic signal is received by the platform for 96 hours, the RA will call the participant
to assess any usability or connectivity issues.
Arm 2: Intervention - Reminders/Feedback (n=20) - Patients will receive tailored text message
reminders to take the medication if in case the interval from last box opening is >30 hours
(greater than 6 hours overdue). Patients will receive weekly text messages with summary
cumulative adherence scores.
Arm 3: Intervention - Reminders/Feedback and Financial Incentives (n=20) - In addition to
reminders with missed doses and weekly adherence feedback, patients in this arm will be
eligible to receive a financial incentive each week they demonstrate perfect >85% adherence.
The weekly adherence feedback message will also alert patients whether they earned the
incentive for the past week.
Inclusion Criteria:
a) age 50 older, b) prescribed a fixed dose combination HCV regimen containing
sofosbuvir/ledipasvir for 12 weeks, and 3) willing to receive text message communications.
Exclusion Criteria:
a) non-English speaking, b) have severe vision, hearing impairment precluding study
participation, c) no text messaging capability, d) decompensated cirrhosis requiring
hospitalization in the past 30 days, e) medication primarily given by a caregiver/facility
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