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

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.

Conditions

• Cardiovascular Disease
• Diabetes
• Breast Cancer
• Depression
• Mental Health Disorder
• Prostatic Hypertrophy, Benign
• Parkinson's Disease
• Epilepsy

Interventions

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.

Sponsors & Collaborators

• CVS Caremark

  collaborator INDUSTRY

• Brigham and Women's Hospital

  lead OTHER

Principal Investigators

• Niteesh K Choudhry, MD, PhD · Brigham and Women's Hospital/Harvard Medical School

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-03-31

Primary Completion

2015-02-28

Completion

2015-02-28

Countries

• United States

Study Locations