Clinical trial NCT02015806: Robust Evaluation to Measure Improvements in Nonadherence From Low-cost Devices
Official title: Assessing the Impact of Low-Touch Devices on Medication Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: CVS Caremark
First posted: 2013-12-19
Enrollment: 53480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Optimal medication adherence to all cardiovascular or non-depression chronic disease medications
timeFrame: 12 months
Secondary outcomes:
measure: Optimal adherence to antidepressants
timeFrame: 12 months
measure: Optimal adherence to the targeted therapies in each randomization block independently
timeFrame: 12 months
measure: Optimal adherence to cardiovascular medications among subjects who are suboptimally adherent to these medications at time of randomization
timeFrame: 12 months
Other outcomes:
Locations:
city: Woonsocket
country: United States
facility: CVS Health
state: Rhode Island
Study officials:
affiliation: Brigham and Women's Hospital/Harvard Medical School
name: Niteesh K Choudhry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.