Hepatitis CWTCNCT02472925
Way to Cure HCV Adherence
A study testing MedSignals Pill Box in people with Hepatitis C, run by University of Pennsylvania at 2 sites in United States.
Trial summary
This is a 3-arm, multi-center, patient-randomized, field evaluation of the "Way to Cure" behavioral interventions on medication adherence in HCV. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- MedSignals Pill Box
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2015to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Corporal Michael J. Crescenz VA Medical Center
Philadelphia, Pennsylvania, 19104
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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.
- Conditions
- Hepatitis C
- Being tested
- MedSignals Pill Box
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedSignals Pill BoxBehavioural
Pill box will provide feedback to the study team regarding subjects' compliance and provide reminders depending on Arm.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Control | Other | 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. Receives: Behavioral: MedSignals Pill Box |
| Arm 2: Reminders/Feedback | Experimental | 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). Receives: Behavioral: MedSignals Pill Box |
| Arm 3: Reminders/Feedback/Incentives | Experimental | 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. Receives: Behavioral: MedSignals Pill Box |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pill bottle measured adherence
Measured: 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2017
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Corporal Michael J. Crescenz VA Medical Center, Northwestern University
- Responsible party
- Sponsor
- Investigators
- Peter Reese, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02472925
- Sponsor's protocol ID
- P30AG034546
- Acronym
- WTC
- Status last verified
- Feb 2022
- First submitted
- 19 Mar 2015
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Way to Cure: Developing Effective Strategies to Promote Adherence to Hepatitis C Therapy Among Older Adults
- ClinicalTrials.gov ID
- NCT02472925
- Acronym / sponsor ID
- WTC / P30AG034546
- Conditions
- Hepatitis C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Corporal Michael J. Crescenz VA Medical Center, Northwestern University
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 16 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 3-arm, multi-center, patient-randomized, field evaluation of the "Way to Cure" behavioral interventions on medication adherence in HCV.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Control | Other | Behavioral: MedSignals Pill BoxMedSignals 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. |
| Arm 2: Reminders/Feedback | Experimental | Behavioral: MedSignals Pill BoxMedSignals 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). |
| Arm 3: Reminders/Feedback/Incentives | Experimental | Behavioral: MedSignals Pill BoxMedSignals 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MedSignals Pill BoxPill box will provide feedback to the study team regarding subjects' compliance and provide reminders depending on Arm. | Behavioural | Arm 1: Control, Arm 2: Reminders/Feedback, Arm 3: Reminders/Feedback/Incentives |
Primary outcome
Pill bottle measured adherence
Time frame: 12 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Reese, MD principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MedSignals Pill Box in people with Hepatitis C, run by University of Pennsylvania at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pill bottle measured adherence (time frame: 12 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022; AzTrials last refreshed its copy on 29 Oct 2026.