Impact of Pillboxes on Medical Adherence

NCT03861845 | Completed Results FDA Device

• 1 other identifier: IRB-18-0451
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study uses an experimental design to test the impact of different types of pillboxes on medication adherence. Participants in this study will randomized to receive one of the three pillbox interventions: 1) A standard seven day a week, one-dose per day pillbox with training 2) an off-the-shelf pillbox that was purchased specifically for the individual's needs with training and education, or 3) a customized 3D printed pillbox that was designed and manufactured specifically to the individual's needs with training and education. Participants will have three visits with the research team to collect baseline data, receive the pillbox, and collect follow up data. Risks to the study include loss of time, boredom, invasion of privacy, and medication errors. The investigators have taken precautions to mitigate these risks. This study will improve understanding of medication adherence and potentially help us better address poor medication adherence which needlessly causes morbidity, mortality, and costs over $300 million in unnecessary healthcare costs each year.

Conditions

Chronic Disease; Medication Adherence

Keywords

Assistive Technology

Outcome Measures

Primary Outcomes (2)

• Medication Adherence at 1 Month

  Medication adherence will be measured by the Adherence to Refills and Medications Scale (ARMS). The ARMS is a 7-item assessment. Participants indicate the extent of their adherence on a 4-point Likert-like scale. Scores range from 7 - 28, with higher scores indicating worse medication adherence.

  1 month

• Satisfaction With Pillbox at 1 Month

  The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) quantifies a participant's satisfaction with their pillbox on a five-point Likert-like scale across 8 features (dimensions, weight, ease in opening/closing the device, safety and security, durability, ease of use, comfort, and effectiveness). A score of 1 indicates not satisfied at all and a score of 5 indicates being very satisfied. Scores indicate the average score on the Likert-like scale.

  1 month

Secondary Outcomes (1)

• Number of Participants Who Completed the Study

  1 month

Study Arms (3)

Standard off-the-shelf pillbox

ACTIVE COMPARATOR

Participants will engage in reflection on medication routines. Then they will receive a standard off-the-shelf pillbox. Finally, the participants will receive education \& training on how to use the pillbox.

Device: Standard off-the-shelf pillbox; Behavioral: Education & Training; Behavioral: Reflection on medication routines

Custom off-the-shelf

EXPERIMENTAL

Participants will engage in reflection on medication routines. Then they will receive a custom off-the-shelf pillbox. Finally, the participants will receive education \& training on how to use the pillbox.

Device: Custom off-the-shelf pillbox; Behavioral: Education & Training; Behavioral: Reflection on medication routines

Custom designed and manufactured

EXPERIMENTAL

Participants will engage in reflection on medication routines. Then they will receive a custom designed and manufactured pillbox. Finally, the participants will receive education \& training on how to use the pillbox.

Device: Custom designed and manufactured pillbox; Behavioral: Education & Training; Behavioral: Reflection on medication routines

Interventions

Standard off-the-shelf pillbox DEVICE

Then the participant will receive a store bought one-dose per day pillbox.

Standard off-the-shelf pillbox

Custom off-the-shelf pillbox DEVICE

Then the participant will be administered an off-the-shelf pillbox that was purchased specifically for the participant's preferences, routine, medication regimen, and skills/abilities.

Custom off-the-shelf

Custom designed and manufactured pillbox DEVICE

Then the participant will describe any design preferences for the pillbox. The researcher will design and manufacture the pillbox using a 3D printer, publically available 3D printing object repository, and computer aided design software.

Custom designed and manufactured

Education & Training BEHAVIORAL

The participant will receive education and training on how to use the pillbox and how to incorporate the pillbox and taking medications into their daily routine.

Custom designed and manufactured; Custom off-the-shelf; Standard off-the-shelf pillbox

Reflection on medication routines BEHAVIORAL

The participant will reflect on his or her daily routine, medication regimen, and use of existing pillboxes. The participant will also engage in a hands-on standardized pillbox task.

Custom designed and manufactured; Custom off-the-shelf; Standard off-the-shelf pillbox

Eligibility Criteria

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

You may qualify if:

• years of age or older
• speak English
• be prescribed to take two or more medications per day, and manage their own medications.

You may not qualify if:

• have a significant cognitive impairment
• unwilling to use a novel pillbox
• unable to meet with the research team

Sponsors & Collaborators

• Florida International University: lead

Study Sites (1)

Florida International University

Miami, Florida, 33199, United States

Location

Related Publications (1)

• Schwartz J, Ballard DH. Feasibility of Customized Pillboxes to Enhance Medication Adherence: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2022 Dec;103(12):2288-2295. doi: 10.1016/j.apmr.2022.03.018. Epub 2022 Apr 14.

  PMID: 35430239 DERIVED

MeSH Terms

Conditions

Chronic Disease; Medication Adherence

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Results Point of Contact

• Title: Dr. Jaclyn Schwartz
• Organization: Florida International University

jschwart@fiu.edu

305-348-3106

Study Officials

• Jaclyn Schwartz, PhD

  Florida International University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2019
• First Posted: March 4, 2019
• Study Start: February 10, 2019
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: August 26, 2020
• Results First Posted: August 26, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)