NCT06901258

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 28, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

March 31, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2025

Completed
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

March 17, 2025

Last Update Submit

April 13, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Medication Adherence

    Baseline, 1 Month

  • Medication Adherence

    Baseline, 1 Month

Study Arms (1)

Genius Pillbox

EXPERIMENTAL

Participants receive Genius Pillbox to use for 1 month

Behavioral: Genius Pillbox

Interventions

Genius PillboxBEHAVIORAL

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.

Genius Pillbox

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 60 or older
  • Taking 3 or more medications
  • Takes medications twice per day or less
  • 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:
  • Age 18 or older
  • Support family member taking 3 or medications, twice a day or less
  • Adequate cognitive capacity (defined as less than 2 errors on 6 item cognitive screener)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Study Officials

  • Rachel O'Conor, PhD, MPH

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 17, 2025

First Posted

March 28, 2025

Study Start

March 31, 2025

Primary Completion

May 23, 2025

Study Completion

May 23, 2025

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations