Robust Evaluation to Measure Improvements in Nonadherence From Low-cost Devices
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer, Depression, Depression, Parkinsons Disease, Peripheral Vascular Disease, Neurology, Orthopedic, Psychiatric, Urology, Epilepsy |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Nephrology / Urology, Neurology, Oncology, Psychiatry / Psychology, Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - 64 |
| Updated: | 4/21/2016 |
| Start Date: | March 2014 |
| End Date: | February 2015 |
Assessing the Impact of Low-Touch Devices on Medication Adherence
The aim of this study is to determine whether adherence to oral maintenance medications
differs for patients randomized to receive a RxTimerCap, a Take-N-Slide, a standard pillbox,
or none of these devices, with the hypothesis that low-touch devices improve adherence over
control and that the increase in adherence is agnostic across devices.
differs for patients randomized to receive a RxTimerCap, a Take-N-Slide, a standard pillbox,
or none of these devices, with the hypothesis that low-touch devices improve adherence over
control and that the increase in adherence is agnostic across devices.
Prior to randomization, all patients meeting the inclusion criteria stratified into two
strata and two blocks within each strata. The first stratum will consist of all patients on
1 to 3 medications for cardiovascular or other non-depression chronic conditions who are
suboptimally adherent to these therapies. The second stratum will include all patients whose
only targeted medications are for depression and who are suboptimally adherent to this
therapy. Given that the Take-N-Slide device only has a Yes/No toggle for each day of the
week and can therefore only be used once per day, each stratum will be further stratified
into two separate blocks based on the frequency with which the study participants'
medications are (or could possibly be) taken. Patients who are on a medication that is used
more than once daily will be randomized in a 2:1 ratio to receive the RxTimerCap, pillbox,
or to continue with usual care. Patients for whom all medications are dosed once daily will
be randomized in a 2:1 ratio to receive the Take-N-Slide, RxTimerCap, pillbox, or to
continue with usual care.
strata and two blocks within each strata. The first stratum will consist of all patients on
1 to 3 medications for cardiovascular or other non-depression chronic conditions who are
suboptimally adherent to these therapies. The second stratum will include all patients whose
only targeted medications are for depression and who are suboptimally adherent to this
therapy. Given that the Take-N-Slide device only has a Yes/No toggle for each day of the
week and can therefore only be used once per day, each stratum will be further stratified
into two separate blocks based on the frequency with which the study participants'
medications are (or could possibly be) taken. Patients who are on a medication that is used
more than once daily will be randomized in a 2:1 ratio to receive the RxTimerCap, pillbox,
or to continue with usual care. Patients for whom all medications are dosed once daily will
be randomized in a 2:1 ratio to receive the Take-N-Slide, RxTimerCap, pillbox, or to
continue with usual care.
Inclusion Criteria:
- Have 1 to 3 oral maintenance medications for chronic disease in the 12-month period
prior to study eligibility evaluation
- Cardiovascular disease (defined as hypertension, hyperlipidemia, coronary artery
disease, congestive heart failure, or diabetes); OR
- Another non-depression chronic condition (defined as breast cancer, benign
prostatic hypertrophy, schizophrenia, bipolar disorder, anxiety, arrythmia;
Parkinson's disease, seizure, and epilepsy); OR
- Depression
- Be suboptimally adherent to their qualifying medications, defined as a Medication
Possession Ratio between 30% and 80% during the 12 months preceding identification of
study eligibility
- Eligible for pharmacy benefits during the 12 months prior to being identified as
being eligible for the study and expected to be eligible for pharmacy benefits
through the end of the evaluation period.
Exclusion Criteria:
- Enrolled in Ready Fill at Mail (a pharmacy benefit program whereby members elect to
have medications shipped automatically to them at the time of refill due date or
prescription renewal).
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