Effects of Use of a Connected Pillbox On Medication Adherence

NCT02593032 | Completed Results

• 1 other identifier: 821737
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Medication adherence is defined as the extent to which a patient takes his or her medication as prescribed by their healthcare provider. One third to one half of all patients in the United States do not take their medication as directed, resulting in nearly $100B in avoidable hospital costs per year. Recent efforts to improve medication adherence in patients with multiple comorbidities have turned to case management and disease management programs. Connected monitoring devices offer an alternative- or supplement- to frequent nurse visits and outreach. These devices enable frequent monitoring and intervention but can also generate large volumes of data that can be difficult for care teams to manage. The present study explores the use of one such device- a technology-enabled, connected pillbox. Given the continued emphasis on bending the cost curve in US healthcare, clinical validation of tools that may improve the management of costly chronic diseases, such as diabetes, is essential.

Conditions

Diabetes Mellitus; Hypertension; Hyperlipidemia

Keywords

hemoglobin A1c protein, human > 7.5

Outcome Measures

Primary Outcomes (1)

• Percent of Participants With Adherence at Month 6

  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)

  6-month interval

Study Arms (2)

Randomized Treatment

EXPERIMENTAL

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.

Device: Pre-filled trays

Control Arm

NO INTERVENTION

Patients in the control arm will receive usual care and can continue using their existing pharmacy.

Interventions

Pre-filled trays DEVICE

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.

Randomized Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Pennsylvania: lead
• TowerView Health: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Hyperlipidemias

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders

Limitations and Caveats

Early termination due to funding constraints, leading to a smaller sample size than originally proposed.

Results Point of Contact

• Title: Dr. Nalaka Gooneratne
• Organization: University of Pennsylvania

ngoonera@pennmedicine.upenn.edu

215 573 2048

Study Officials

• Nalaka S Gooneratne, MD

  University of Pennsylvannia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: October 30, 2015
• Study Start: February 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: September 21, 2017
• Last Updated: August 4, 2020
• Results First Posted: August 4, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)