Ignite Creation Date:
2024-05-06 @ 2:19 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02015806
Status:
COMPLETED
Last Update Posted:
2016-01-11
First Post:
2013-12-13
Brief Title:
Robust Evaluation to Measure Improvements in Nonadherence From Low-cost Devices
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Assessing the Impact of Low-Touch Devices on Medication Adherence
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REMIND
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 YesNo 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 21 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 21 ratio to receive the Take-N-Slide RxTimerCap pillbox or to continue with usual care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None