Trial Outcomes & Findings for Effects of Use of a Connected Pillbox On Medication Adherence (NCT NCT02593032)

Last Updated: 2020-08-04

Results Overview

The primary outcome of interest in the present study is improvement in adherence. We will determine if a multi-modal intervention focused on improving medication adherence among adults who were previously non-adherent results in improved medication adherence over a 6-month interval averaged across months 1 to 6. This will be reported as the percent persistent on therapy at 6 months across the three conditions (diabetes, HTN, hyperlipidemia)

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

6-month interval

Results posted on

2020-08-04

Participant Flow

Participant milestones

Participant milestones
Measure	Randomized Treatment Patients in the treatment group will begin receiving their medications in pre-filled trays from Friendship Pharmacy. Patients will receive 5 trays on a monthly basis in order to accommodate a 30-day, insurance-reimbursed fill schedule. Pre-filled trays: Randomized Control Trial Patients in the research treatment group receive pre-filled, 3x7 disposable trays that separate their medication by dose and time (e.g. morning, afternoon, evening). These pre-filled trays are inserted into a connected, weekly pillbox that detects when pills are removed from its wells.	Control Arm Patients in the control arm will receive usual care and can continue using their existing pharmacy.
Overall Study STARTED	17	33
Overall Study COMPLETED	17	33
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Use of a Connected Pillbox On Medication Adherence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Randomized Treatment n=17 Participants Patients in the treatment group will begin receiving their medications in pre-filled trays from Friendship Pharmacy. Patients will receive 5 trays on a monthly basis in order to accommodate a 30-day, insurance-reimbursed fill schedule. Pre-filled trays: Randomized Control Trial Patients in the research treatment group receive pre-filled, 3x7 disposable trays that separate their medication by dose and time (e.g. morning, afternoon, evening). These pre-filled trays are inserted into a connected, weekly pillbox that detects when pills are removed from its wells.	Control Arm n=33 Participants Patients in the control arm will receive usual care and can continue using their existing pharmacy.	Total n=50 Participants Total of all reporting groups
Age, Continuous	62 years STANDARD_DEVIATION 3.2 • n=5 Participants	65 years STANDARD_DEVIATION 3.4 • n=7 Participants	64 years STANDARD_DEVIATION 3.3 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	25 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	24 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Self-reported adherence status to all medications	15 Number with self-reported low adherence n=5 Participants	31 Number with self-reported low adherence n=7 Participants	46 Number with self-reported low adherence n=5 Participants

PRIMARY outcome

Timeframe: 6-month interval

Outcome measures

Outcome measures
Measure	Randomized Treatment n=17 Participants Patients in the treatment group will begin receiving their medications in pre-filled trays from Friendship Pharmacy. Patients will receive 5 trays on a monthly basis in order to accommodate a 30-day, insurance-reimbursed fill schedule. Pre-filled trays: Randomized Control Trial Patients in the research treatment group receive pre-filled, 3x7 disposable trays that separate their medication by dose and time (e.g. morning, afternoon, evening). These pre-filled trays are inserted into a connected, weekly pillbox that detects when pills are removed from its wells.	Control Arm n=33 Participants Patients in the control arm will receive usual care and can continue using their existing pharmacy.
Percent of Participants With Adherence at Month 6	91 percent persistent on therapy	40 percent persistent on therapy

Adverse Events

Randomized Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Nalaka Gooneratne

University of Pennsylvania

Phone: 215 573 2048

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place