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

Mass General Brigham

Status: Completed

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

Treatments: Behavioral: Pillbox; Behavioral: RxTimerCap; Behavioral: Take-N-Slide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02015806

2013-P-00009085

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53,480 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No 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).

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

53,480 participants in 14 patient groups

All meds but depression, 1x daily use, RxTimerCap

Experimental group

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.

Treatment:

Behavioral: RxTimerCap

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

Experimental group

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.

Treatment:

Behavioral: Take-N-Slide

All meds but depression, 1x daily use, pillbox

Experimental group

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.

Treatment:

Behavioral: Pillbox

All meds but depression, 1x daily use, control

No Intervention group

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.

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

Experimental group

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.

Treatment:

Behavioral: RxTimerCap

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

Experimental group

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.

Treatment:

Behavioral: Pillbox

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

No Intervention group

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.

Only depression meds, 1x daily use, RxTimerCap

Experimental group

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.

Treatment:

Behavioral: RxTimerCap

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

Experimental group

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.

Treatment:

Behavioral: Take-N-Slide

Only depression meds, 1x daily use, pillbox

Experimental group

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.

Treatment:

Behavioral: Pillbox

Only depression meds, 1x daily use, control

No Intervention group

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.

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

Experimental group

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.

Treatment:

Behavioral: RxTimerCap

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

Experimental group

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.

Treatment:

Behavioral: Pillbox

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

No Intervention group

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.