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
  Purpose

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.


Condition Intervention
Cardiovascular Disease
Diabetes
Breast Cancer
Depression
Mental Health Disorder
Prostatic Hypertrophy, Benign
Parkinson's Disease
Epilepsy
Behavioral: RxTimerCap
Behavioral: Take-N-Slide
Behavioral: Pillbox

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Assessing the Impact of Low-Touch Devices on Medication Adherence

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 53480
Study Start Date: March 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02015806

Locations
United States, Rhode Island
CVS Health
Woonsocket, Rhode Island, United States, 02895
Sponsors and Collaborators
Brigham and Women's Hospital
CVS Health
Investigators
Principal Investigator: Niteesh K Choudhry, MD, PhD Brigham and Women's Hospital/Harvard Medical School
  More Information

No publications provided

Responsible Party: Niteesh K. Choudhry, MD, PhD, Associate Professor, Harvard Medical School, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02015806     History of Changes
Other Study ID Numbers: 2013-P-00009085
Study First Received: December 13, 2013
Last Updated: February 9, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Quality improvement
Randomized controlled trial
Medication adherence
RxTimer Cap
PillMinder
Take-N-Slide
Low-touch devices
Medication management

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertrophy
Mental Disorders
Parkinson Disease
Prostatic Hyperplasia
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Genital Diseases, Male
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Pathological Conditions, Anatomical
Prostatic Diseases

ClinicalTrials.gov processed this record on July 30, 2015