The Impact of Patch Rx Technologies on Adherence to Vitamin and Trikafta Therapies in Patients With Cystic Fibrosis

NCT04684823 | Completed FDA Device

• 1 other identifier: HSC20200875H
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This proposed pilot study will assess if the Patch Technology system will increase adherence in patients with cystic fibrosis followed at the UTHSCSA Cystic Fibrosis Center.

Conditions

Cystic Fibrosis; Adherence, Medication

Outcome Measures

Primary Outcomes (2)

• Adherence to Trikafta dosing

  Tracking of medication compliance over the time where the Patch Cap and Patch App are used by determining number of days compliance

  Baseline to 90 days

• Adherence to Multivitamin dosing

  Tracking of medication compliance over the time where the Patch Cap and Patch App are used by determining number of days compliance

  Baseline to 90 days

Secondary Outcomes (3)

• Patch vs Self Reported Adherence for Trikafta

  Baseline to 90 days

• Patch vs Self Reported Adherence for Multivitamin

  Baseline to 90 days

• Median Dosing Interval

  Baseline to 90 days

Study Arms (1)

Use of Patch Cap and Patch App

EXPERIMENTAL

Subjects will use Patch Technologies to track their medication regimen compliance

Device: Patch Cap; Device: Patch App

Interventions

Patch Cap DEVICE

A prescription container cap to track the dispensing of an oral dose of medication with an associated app which tracks the adherence to medication regimen.

Use of Patch Cap and Patch App

Patch App DEVICE

A mobile app that is used with Patch Cap to track adherence to medication regimen

Use of Patch Cap and Patch App

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with CF and cared for at University of Texas Health San Antonio Cystic Fibrosis clinic
• \> 12 years of age
• Prescribed a daily CF specific vitamin for at least 6 month
• Prescribed the genetic modulator elexacaftor/tezacaftor/ivacaftor for at least 6 month
• English speaking
• Patient possesses a Bluetooth enabled smartphone or mobile device.

You may not qualify if:

• \) Patient is already using some other medication therapy management (MTM) service.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Patch Rx Technologies: collaborator

Study Sites (1)

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis; Medication Adherence

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Donna Beth J Willey-Courand, MD

  UT Health San Antonio

  PRINCIPAL INVESTIGATOR

• Sarah J Kubes, Pharm D

  UT Health San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm device pilot study

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 28, 2020
• Study Start: January 15, 2021
• Primary Completion: December 27, 2021
• Study Completion: December 27, 2021
• Last Updated: January 4, 2022

Record last verified: 2022-01

Locations

US (1)