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

Primary Purpose

Cardiovascular Disease, Diabetes, Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RxTimerCap
Take-N-Slide
Pillbox
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cardiovascular Disease focused on measuring Quality improvement, Randomized controlled trial, Medication adherence, RxTimer Cap, PillMinder, Take-N-Slide, Low-touch devices, Medication management

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • CVS Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm Type

Experimental

Experimental

Experimental

No Intervention

Experimental

Experimental

No Intervention

Experimental

Experimental

Experimental

No Intervention

Experimental

Experimental

No Intervention

Arm Label

All meds but depression, 1x daily use, RxTimerCap

All meds but depression, 1x daily use, Take-N-Slide

All meds but depression, 1x daily use, pillbox

All meds but depression, 1x daily use, control

All meds but depression, ≥1 med >1 daily use, RxTimerCap

All meds but depression, ≥1 med >1 daily use, pillbox

All meds but depression, ≥1 med >1 daily use, control

Only depression meds, 1x daily use, RxTimerCap

Only depression meds, 1x daily use, Take-N-Slide

Only depression meds, 1x daily use, pillbox

Only depression meds, 1x daily use, control

Only depression meds, ≥1 med >1 daily use, RxTimerCap

Only depression meds, ≥1 med >1 daily use, pillbox

Only depression meds, ≥1 med >1 daily use, control

Arm Description

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Optimal medication adherence to all cardiovascular or non-depression chronic disease medications
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
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
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
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

Full Information

First Posted
December 13, 2013
Last Updated
January 7, 2016
Sponsor
Brigham and Women's Hospital
Collaborators
CVS Caremark
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1. Study Identification

Unique Protocol Identification Number
NCT02015806
Brief Title
Robust Evaluation to Measure Improvements in Nonadherence From Low-cost Devices
Acronym
REMIND
Official Title
Assessing the Impact of Low-Touch Devices on Medication Adherence
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
CVS Caremark

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Diabetes, Breast Cancer, Depression, Mental Health Disorder, Prostatic Hypertrophy, Benign, Parkinson's Disease, Epilepsy
Keywords
Quality improvement, Randomized controlled trial, Medication adherence, RxTimer Cap, PillMinder, Take-N-Slide, Low-touch devices, Medication management

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53480 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All meds but depression, 1x daily use, RxTimerCap
Arm Type
Experimental
Arm Description
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.
Arm Title
All meds but depression, 1x daily use, Take-N-Slide
Arm Type
Experimental
Arm Description
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.
Arm Title
All meds but depression, 1x daily use, pillbox
Arm Type
Experimental
Arm Description
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.
Arm Title
All meds but depression, 1x daily use, control
Arm Type
No Intervention
Arm Description
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.
Arm Title
All meds but depression, ≥1 med >1 daily use, RxTimerCap
Arm Type
Experimental
Arm Description
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.
Arm Title
All meds but depression, ≥1 med >1 daily use, pillbox
Arm Type
Experimental
Arm Description
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.
Arm Title
All meds but depression, ≥1 med >1 daily use, control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Only depression meds, 1x daily use, RxTimerCap
Arm Type
Experimental
Arm Description
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.
Arm Title
Only depression meds, 1x daily use, Take-N-Slide
Arm Type
Experimental
Arm Description
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.
Arm Title
Only depression meds, 1x daily use, pillbox
Arm Type
Experimental
Arm Description
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.
Arm Title
Only depression meds, 1x daily use, control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Only depression meds, ≥1 med >1 daily use, RxTimerCap
Arm Type
Experimental
Arm Description
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.
Arm Title
Only depression meds, ≥1 med >1 daily use, pillbox
Arm Type
Experimental
Arm Description
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.
Arm Title
Only depression meds, ≥1 med >1 daily use, control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
RxTimerCap
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Take-N-Slide
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pillbox
Intervention Description
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.
Primary Outcome Measure Information:
Title
Optimal medication adherence to all cardiovascular or non-depression chronic disease medications
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Optimal adherence to antidepressants
Description
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
Time Frame
12 months
Title
Optimal adherence to the targeted therapies in each randomization block independently
Description
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
Time Frame
12 months
Title
Optimal adherence to cardiovascular medications among subjects who are suboptimally adherent to these medications at time of randomization
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niteesh K Choudhry, MD, PhD
Organizational Affiliation
Brigham and Women's Hospital/Harvard Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
CVS Health
City
Woonsocket
State/Province
Rhode Island
ZIP/Postal Code
02895
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33089492
Citation
Al-Aqeel S, Gershuni O, Al-Sabhan J, Hiligsmann M. Strategies for improving adherence to antiepileptic drug treatment in people with epilepsy. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD008312. doi: 10.1002/14651858.CD008312.pub4.
Results Reference
derived
PubMed Identifier
28241271
Citation
Choudhry NK, Krumme AA, Ercole PM, Girdish C, Tong AY, Khan NF, Brennan TA, Matlin OS, Shrank WH, Franklin JM. Effect of Reminder Devices on Medication Adherence: The REMIND Randomized Clinical Trial. JAMA Intern Med. 2017 May 1;177(5):624-631. doi: 10.1001/jamainternmed.2016.9627.
Results Reference
derived

Learn more about this trial

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

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