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

NCT02015806 | Completed

• 1 other identifier: 2013-P-00009085
• Study Type: interventional
• Target: 53,480
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (3)

• Optimal adherence to antidepressants

  12 months

• Optimal adherence to the targeted therapies in each randomization block independently

  12 months

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

  12 months

Study Arms (14)

All meds but depression, 1x daily use, RxTimerCap

EXPERIMENTAL

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

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

EXPERIMENTAL

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

All meds but depression, 1x daily use, pillbox

EXPERIMENTAL

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

All meds but depression, 1x daily use, control

NO INTERVENTION

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.

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

NO INTERVENTION

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.

Only depression meds, 1x daily use, RxTimerCap

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Only depression meds, 1x daily use, pillbox

EXPERIMENTAL

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

Only depression meds, 1x daily use, control

NO INTERVENTION

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.

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

NO INTERVENTION

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.

Interventions

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.

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

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.

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

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.

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

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• CVS Caremark: collaborator

Study Sites (1)

CVS Health

Woonsocket, Rhode Island, 02895, United States

Location

Related Publications (2)

• 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.

  PMID: 33089492 DERIVED

• 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.

  PMID: 28241271 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus; Breast Neoplasms; Depression; Mental Disorders; Prostatic Hyperplasia; Parkinson Disease; Epilepsy; Medication Adherence

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavioral Symptoms; Behavior; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Niteesh K Choudhry, MD, PhD

  Brigham and Women's Hospital/Harvard Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Harvard Medical School

Study Record Dates

• First Submitted: December 13, 2013
• First Posted: December 19, 2013
• Study Start: March 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: January 11, 2016

Record last verified: 2016-01

Locations

US (1)