Skip to main content
OpenTrials
Completed

NCT Number: NCT02015806

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Disease Basal Ganglia Diseases Behavior Behavioral Symptoms Brain Diseases Breast Cancer Breast Diseases Breast Neoplasms Cardiovascular Diseases Central Nervous System Diseases Depression Diabetes Diabetes Mellitus Endocrine System Diseases Epilepsy Genital Diseases Genital Diseases, Male Glucose Metabolism Disorders Health Behavior Male Urogenital Diseases Medication Adherence Mental Disorders Mental Health Disorder Metabolic Diseases Movement Disorders Neoplasms Neoplasms by Site Nervous System Diseases Neurodegenerative Diseases Nutritional and Metabolic Diseases Parkinson Disease Parkinson's Disease Parkinsonian Disorders Patient Acceptance of Health Care Patient Compliance Prostatic Diseases Prostatic Hyperplasia Prostatic Hypertrophy, Benign Skin Diseases Skin and Connective Tissue Diseases Synucleinopathies Treatment Adherence and Compliance Urogenital Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CVS Health

Woonsocket, Rhode Island, 02895, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

RxTimerCap

Behavioral

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.

Take-N-Slide

Behavioral

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.

Pillbox

Behavioral

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 outcomes

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

    Time frame: 12 months

    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 outcomes

  1. Optimal adherence to antidepressants

    Time frame: 12 months

    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

  2. Optimal adherence to the targeted therapies in each randomization block independently

    Time frame: 12 months

    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

  3. Optimal adherence to cardiovascular medications among subjects who are suboptimally adherent to these medications at time of randomization

    Time frame: 12 months

    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

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • CVS Caremark

Registry information

Official study title

Assessing the Impact of Low-Touch Devices on Medication Adherence

Acronym: REMIND

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 19, 2013
Registry last updated
Jan 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.