Genius PillBox Study

Genius PillBox: Pilot and Feasibility Study

The purpose of this study is to pilot test the how acceptable older adults find a commercially available pillbox organizer with embedded sensors and automated reminders to support medication adherence.

Study Overview

• Status: Completed
• Conditions: Older Adults (65 Years and Older)
• Intervention / Treatment: Behavioral: Genius Pillbox

Detailed Description

The purpose of this study is to pilot test how acceptable older adults find a commercially available pillbox organizer with embedded sensors and automated reminders to support medication adherence. Individuals who agree to participate in the study will be provided with the pillbox organizer and asked to use the pillbox for 1 month. The pillbox contains 7 compartments with embedded sensors that detects if there is a pill present. Blinking lights and a flashing letter specifying the day of the week, are used to alert users to take their medicines. After taking the first dose, a 24-hour count down timer will begin. If the medication specified for that day is not taken within the target time the device will beep to alert the user. Participants will complete a structured interview at baseline and 1 month follow-up to assess demographic and health related information, medication adherence and how they found using the pillbox organizer. Additionally, if individuals have a family member who supports their medication use, they will be asked to complete an interview at the 1 month follow-up to understand how they found using the pillbox organizer.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Primary Inclusion Criteria are for older adults who manage multi-drug regimens. Inclusion Criteria:

1. Age 60 or older
2. Taking 3 or more medications
3. Takes medications twice per day or less
4. Adequate cognitive capacity (defined as less than 2 errors on 6 item cognitive screener).

Additionally, a family member that assists with a participant's medicines can also be invited to participate. The family member eligibility criteria is:

1. Age 18 or older
2. Support family member taking 3 or medications, twice a day or less
3. Adequate cognitive capacity (defined as less than 2 errors on 6 item cognitive screener)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Genius Pillbox; Participants receive Genius Pillbox to use for 1 month

Behavioral: Genius Pillbox; Participants will be mailed a Genius Pillbox to their home address. Along with the pillbox, they will also receive a detailed written description to orient them to the Genius Pillbox. Participants will be expected to use the Genius pill box organizer daily for four weeks as part of their usual medication routine. Participants are also expected to fill the designated compartments with their daily pills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Pillbox	Acceptability Questionnaire, scores range from 9-36, higher scores indicate greater acceptability.	1 Month
Fidelity of Pillbox Use	Individual items to assess use of pillbox over 30-day period. 3 items will quantify the degree and extent which the participant used the pillbox over the past 30 day.	1 Month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Adherence	Extent of Medication Nonadherence Scale. 3-item questionnaire, scores range from 1-5 (lower scores indicate better medication adherence)	Baseline, 1 Month
Medication Adherence	Patient Medication Adherence Questionnaire. 3-item questionnaire, scores are summed (range 0-3), and scores of 1 or greater = non-adherence	Baseline, 1 Month

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Rachel O'Conor, PhD, MPH, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2025
• Primary Completion (Actual): May 23, 2025
• Study Completion (Actual): May 23, 2025

Study Registration Dates

• First Submitted: March 17, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): March 28, 2025

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: STU00223484

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No