Robust Evaluation to Measure Improvements in Nonadherence From Low-cost Devices (REMIND)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
CVS Health
Information provided by (Responsible Party):
Niteesh K. Choudhry, MD, PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT02015806
First received: December 13, 2013
Last updated: February 9, 2015
Last verified: February 2015

December 13, 2013
February 9, 2015
March 2014
February 2015   (final data collection date for primary outcome measure)
Optimal medication adherence to all cardiovascular or non-depression chronic disease medications [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Optimal adherence to all cardiovascular or non-depression chronic disease medications, defined as a Medication Possession Ratio (MPR) equal to or greater than 80% and assessed using administrative pharmacy claims
Optimal medication adherence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Optimal adherence to medications will be defined as a Medication Possession Ratio (MPR) equal to or greater than 0.80 and assessed using administrative pharmacy claims
Complete list of historical versions of study NCT02015806 on ClinicalTrials.gov Archive Site
  • Optimal adherence to antidepressants [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Optimal adherence to antidepressants among subjects whose only targeted therapy is an antidepressant, calculated using Medication Possession Ratios (MPR) and assessed using administrative pharmacy claims
  • Optimal adherence to the targeted therapies in each randomization block independently [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Optimal adherence to the targeted therapies in each of the randomization blocks independently, calculated using Medication Possession Ratios (MPR) and assessed using administrative pharmacy claims
  • Optimal adherence to cardiovascular medications among subjects who are suboptimally adherent to these medications at time of randomization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Optimal adherence to cardiovascular medications among subjects who are suboptimally adherent to these medications at time of randomization, calculated using Medication Possession Ratios (MPR) and assessed using administrative pharmacy claims
Mean Medication Possession Ratio (MPR) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
A member level MPR will be calculated over the follow-up period for each targeted condition and then averaged
Not Provided
Not Provided
 
Robust Evaluation to Measure Improvements in Nonadherence From Low-cost Devices
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Cardiovascular Disease
  • Diabetes
  • Breast Cancer
  • Depression
  • Mental Health Disorder
  • Prostatic Hypertrophy, Benign
  • Parkinson's Disease
  • Epilepsy
  • Behavioral: RxTimerCap
    The RxTimerCap is a pill bottle cap with a digital timer that shows the time elapsed since the medication was last taken. Patients randomized to receive the RxTimerCap will receive a one-time mailing with one device for each of the maintenance medications they were using at the time of identification for study eligibility; additionally, patients will receive an information card explaining the device's use which includes a telephone number at which they can get additional information.
  • Behavioral: Take-N-Slide
    The Take-N-Slide device is a patented strip with toggles for each day of the week which are meant to be slid after taking a medication. Each Take-N-Slide can be removed and reused for the next prescription bottle. Patients randomized to receive Take-N-Slide will receive a one-time mailing with one device for each of the maintenance medications they were using at the time of identification for study eligibility; additionally, patients will receive an information card explaining the device's use which includes a telephone number at which they can get additional information.
  • Behavioral: Pillbox
    The standard pillbox is a plastic organization box with one compartment for every day of the week. Patients randomized to receive a pillbox will receive a one-time mailing with one device for each of the maintenance medications they were using at the time of identification for study eligibility; additionally, patients will receive an information card explaining the device's use which includes a telephone number at which they can get additional information.
  • Experimental: All meds but depression, 1x daily use, RxTimerCap
    Individuals who are taking 1-3 cardiovascular or other non-depression chronic disease medications and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to receive a RxTimerCap.
    Intervention: Behavioral: RxTimerCap
  • Experimental: All meds but depression, 1x daily use, Take-N-Slide
    Individuals who are taking 1-3 cardiovascular or other non-depression chronic disease medications and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to receive a Take-N-Slide.
    Intervention: Behavioral: Take-N-Slide
  • Experimental: All meds but depression, 1x daily use, pillbox
    Individuals who are taking 1-3 cardiovascular or other non-depression chronic disease medications and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to receive a standard pillbox.
    Intervention: Behavioral: Pillbox
  • No Intervention: All meds but depression, 1x daily use, control
    Individuals who are taking 1-3 cardiovascular or other non-depression chronic disease medications and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to continue with usual care.
  • Experimental: All meds but depression, ≥1 med >1 daily use, RxTimerCap
    Individuals who are taking 1-3 cardiovascular or other non-depression chronic disease medications and who are suboptimally adherent to these therapies, who have at least one medication that is intended for use more than once daily, and who are randomized to receive a RxTimerCap.
    Intervention: Behavioral: RxTimerCap
  • Experimental: All meds but depression, ≥1 med >1 daily use, pillbox
    Individuals who are taking 1-3 cardiovascular or other non-depression chronic disease medications and who are suboptimally adherent to these therapies, who have at least one medication that is intended for use more than once daily, and who are randomized to receive a standard pillbox.
    Intervention: Behavioral: Pillbox
  • No Intervention: All meds but depression, ≥1 med >1 daily use, control
    Individuals who are taking 1-3 cardiovascular or other non-depression chronic disease medications and who are suboptimally adherent to these therapies, who have at least one medication that is intended for use more than once daily, and who are randomized to continue with usual care.
  • Experimental: Only depression meds, 1x daily use, RxTimerCap
    Individuals who are taking only antidepressants and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to receive a RxTimerCap.
    Intervention: Behavioral: RxTimerCap
  • Experimental: Only depression meds, 1x daily use, Take-N-Slide
    Individuals who are taking only antidepressants and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to receive a Take-N-Slide.
    Intervention: Behavioral: Take-N-Slide
  • Experimental: Only depression meds, 1x daily use, pillbox
    Individuals who are taking only antidepressants and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to receive a standard pillbox.
    Intervention: Behavioral: Pillbox
  • No Intervention: Only depression meds, 1x daily use, control
    Individuals who are taking only antidepressants and who are suboptimally adherent to these therapies, whose medications are all intended for once daily use, and who are randomized to continue with usual care.
  • Experimental: Only depression meds, ≥1 med >1 daily use, RxTimerCap
    Individuals who are taking only antidepressants and who are suboptimally adherent to these therapies, who have at least one medication that is intended for use more than once daily, and who are randomized to receive a RxTimerCap.
    Intervention: Behavioral: RxTimerCap
  • Experimental: Only depression meds, ≥1 med >1 daily use, pillbox
    Individuals who are taking only antidepressants and who are suboptimally adherent to these therapies, who have at least one medication that is intended for use more than once daily, and who are randomized to receive a standard pillbox.
    Intervention: Behavioral: Pillbox
  • No Intervention: Only depression meds, ≥1 med >1 daily use, control
    Individuals who are taking only antidepressants and who are suboptimally adherent to these therapies, who have at least one medication that is intended for use more than once daily, and who are randomized to continue with usual care.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
53480
February 2015
February 2015   (final data collection date for primary outcome measure)

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).
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT02015806
2013-P-00009085
Not Provided
Niteesh K. Choudhry, MD, PhD, Brigham and Women's Hospital
Brigham and Women's Hospital
CVS Health
Principal Investigator: Niteesh K Choudhry, MD, PhD Brigham and Women's Hospital/Harvard Medical School
Brigham and Women's Hospital
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP