WTC: Way to Cure HCV Adherence

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT02472925
• Collaborator: Corporal Michael J. Crescenz VA Medical Center (U.S. Fed), Northwestern University (Other)
• Enrollment: 60
• Locations: 2
• Arms: 3
• Actual Duration (Months): 78
• Patients Per Site: 30
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This is a 3-arm, multi-center, patient-randomized, field evaluation of the "Way to Cure" behavioral interventions on medication adherence in HCV.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C	Behavioral: MedSignals Pill Box	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Way to Cure: Developing Effective Strategies to Promote Adherence to Hepatitis C Therapy Among Older Adults
• Actual Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Arm 1: Control MedSignals pill box will be set into "quiet mode" to track patient compliance. This mode sends daily adherence data to the Way to Health platform each time the participant opens the pill box, however, does not remind the participant to take the medication.	Behavioral: MedSignals Pill Box; Pill box will provide feedback to the study team regarding subjects' compliance and provide reminders depending on Arm.
Experimental: Arm 2: Reminders/Feedback MedSignals pill box will track patient compliance and the Way to Health platform will allow participants to receive tailored text message reminders to take the medication if in case the interval from last cap opening is >30 hours (greater than 6 hours overdue).	Behavioral: MedSignals Pill Box; Pill box will provide feedback to the study team regarding subjects' compliance and provide reminders depending on Arm.
Experimental: Arm 3: Reminders/Feedback/Incentives MedSignals pill box will track patient compliance and in addition to reminders with missed doses and weekly adherence feedback, patients in this arm will be eligible to receive a small 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.	Behavioral: MedSignals Pill Box; Pill box will provide feedback to the study team regarding subjects' compliance and provide reminders depending on Arm.

Outcome Measures

Primary Outcome Measures

1. Pill bottle measured adherence [12 weeks of treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 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:

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Corporal Michael J. Crescenz VA Medical Center	Philadelphia	Pennsylvania	United States	19104
2	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania
• Corporal Michael J. Crescenz VA Medical Center
• Northwestern University

Investigators

• Principal Investigator: Peter Reese, MD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT02472925
• Other Study ID Numbers: P30AG034546
• First Posted: Jun 16, 2015
• Last Update Posted: Feb 8, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hepatitis C; Hepatitis

Study Results

No Results Posted as of Feb 8, 2022