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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Brigham and Women's Hospital
Sponsor:
Collaborator:
CVS Caremark
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: March 5, 2014
Last verified: March 2014
  Purpose

The aim of this study is to determine whether adherence to oral maintenance medications differs for patients randomized to receive a Take-N-Slide, a RxTimerCap, a PillMinder, 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
Breast Cancer
Cardiovascular Disease
Depression
Diabetes
Mental Health Disorder
Behavioral: Rx Timer Cap
Behavioral: PillMinder
Behavioral: Take-N-Slide

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 among patients suboptimally adherent to targeted medications excluding antidepressants [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Optimal adherence to medications is defined as a Medication Possession Ratio (MPR) equal to or greater than 0.80 and assessed using administrative pharmacy claims


Secondary Outcome Measures:
  • Average adherence among patients suboptimally adherent to targeted medications including those intended to treat depression [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Medication adherence will be calculated using Medication Possession Ratios (MPR) for each of the targeted therapies the patient is on, and assessed using administrative pharmacy claims


Other Outcome Measures:
  • Average medication adherence for patients whose only targeted medications are for depression and who are suboptimally adherent to this therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Medication adherence will be calculated using Medication Possession Ratios (MPR) for antidepressants, and assessed using administrative pharmacy claims


Estimated Enrollment: 60000
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 1x daily use, all but depression, Rx Timer Cap
Individuals that are suboptimally adherent to targeted therapies except antidepressants, whose medications are all intended for once daily use and are randomized to receive the Rx Timer Cap
Behavioral: Rx Timer Cap
The RxTimer Cap is a pill bottle with a digital timer on the cap 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 1x daily use, only depression, Rx Timer Cap
Individuals whose only targeted medications are for depression, whose medications are intended for once daily use and are randomized to receive the Rx Timer Cap
Behavioral: Rx Timer Cap
The RxTimer Cap is a pill bottle with a digital timer on the cap 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 1x daily use, all but depression, PillMinder
Individuals that are suboptimally adherent to targeted therapies except antidepressants, whose medications are all intended for once daily use and are randomized to receive the PillMinder
Behavioral: PillMinder
The 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 1x daily use, only depression, PillMinder
Individuals whose only targeted medications are for depression, whose medications are intended for once daily use and are randomized to receive the PillMinder
Behavioral: PillMinder
The 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 1x daily use, all but depression, Take-N-Slide
Individuals that are suboptimally adherent to targeted therapies except antidepressants, whose medications are all intended for once daily use and are randomized to receive the 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 1x daily use, only depression, Take-N-Slide
Individuals whose only targeted medications are for depression, whose medications are intended for once daily use and are randomized to receive the 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.
No Intervention: All meds 1x daily use, all but depression, Control
Individuals that are suboptimally adherent to targeted therapies except antidepressants, whose medications are all intended for once daily use and are randomized to proceed with usual care
No Intervention: All meds 1x daily use, only depression, Control
Individuals whose only targeted medications are for depression, whose medications are intended for once daily use and are randomized to proceed with usual care
Experimental: 1 med ≥2x daily use, all but depression, Rx Timer Cap
Individuals who are suboptimally adherent to targeted therapies except antidepressants, who have at least one medication that is intended for use more than once daily and are randomized to receive the Rx Timer Cap
Behavioral: Rx Timer Cap
The RxTimer Cap is a pill bottle with a digital timer on the cap 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: ≥1 med ≥2x daily use, only depression, Rx Timer Cap
Individuals whose only targeted medications are for depression and who are suboptimally adherent to this therapy, for whom at least one medication is intended for use more than once daily and are randomized to receive the Rx Timer Cap
Behavioral: Rx Timer Cap
The RxTimer Cap is a pill bottle with a digital timer on the cap 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: ≥1 med ≥2x daily use, all but depression, PillMinder
Individuals who are suboptimally adherent to targeted therapies except antidepressants, who have at least one medication that is intended for use more than once daily and are randomized to receive the PillMinder
Behavioral: PillMinder
The 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: ≥1 med ≥2x daily use, only depression, PillMinder
Individuals whose only targeted medications are for depression and who are suboptimally adherent to this therapy, for whom at least one medication is intended for use more than once daily and are randomized to receive the PillMinder
Behavioral: PillMinder
The 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: ≥1 med ≥2x daily use, all but depression, Control
Individuals who are suboptimally adherent to targeted therapies except antidepressants, who have at least one medication that is intended for use more than once daily and are randomized to proceed with usual care
No Intervention: ≥1 med ≥2x daily use, only depression, Control
Individuals whose only targeted medications are for depression and who are suboptimally adherent to this therapy, for whom at least one medication is intended for use more than once daily and are randomized to proceed with usual care

Detailed Description:

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, the study population will be stratified into two separate trials 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 included in Trial 2, which evaluates only the RxTimer Cap and the PillMinder. Within each trial, all patients meeting the inclusion criteria within each trial will be randomized into two blocks, the first of which will consist of all patients suboptimally adherent to all targeted medications excluding antidepressants, and the second of all patients whose only targeted medications are for depression and who are suboptimally adherent to this therapy.

  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 in pill or capsule form and filled via mail order or at a retail pharmacy within 12 months prior to being identified as being eligible for the study, at least one of which must be intended for either:
  • A chronic condition (defined as breast cancer, cardiovascular disease, diabetes or a major mental health condition); OR
  • Depression.
  • Be suboptimally adherent to all of the targeted drug classes, defined as a Medication Possession Ratio (see Outcomes and Analysis section below for definition) of 30% to less than 80% during the 12 months preceding identification of study eligibility, except where noted below;
  • For patients taking antidepressants in addition to other targeted medications, patients need only be suboptimally adherent to their non-antidepressant medications;.
  • 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 Caremark Not yet recruiting
Woonsocket, Rhode Island, United States, 02895
Contact: Charmaine Girdish    480-707-6645    Charmaine.Girdish@caremark.com   
Sponsors and Collaborators
Brigham and Women's Hospital
CVS Caremark
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: March 5, 2014
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:
Mental Disorders
Breast Neoplasms
Cardiovascular Diseases
Depression
Depressive Disorder
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on July 20, 2014