AzTrials
AzTrials

Cystic FibrosisNCT04684823

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

A study testing Patch Cap and Patch App in people with Cystic Fibrosis and Adherence, Medication, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Cystic Fibrosis, Adherence, Medication
What is being tested?
Patch Cap and Patch App
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
15 Jan 2021to 27 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: The Impact of Patch Rx Technologies on Adherence to Vitamin and Trikafta® (Elexacaftor/Tezacaftor/Ivacaftor) Therapies in Patients With Cystic Fibrosis

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.

Read the detailed description

This trial will follow patients' adherence with their current medication regimen and will not impact the medications they are prescribed. Patients will be enrolled during a regularly scheduled Cystic Fibrosis Clinic visit. When participants receive their reminder calls for the clinic visit, they will be asked to bring their prescribed vitamins in the pharmacy dispensed bottle with them. During the clinic visit, the study will be reviewed, and consent will be obtained. After enrollment, patients will complete a survey indicating their understanding of the reason for taking vitamins/genetic modulators, the importance they place on taking the medications, self-reported adherence to the therapies, and reasons for being non-adherent. Participants will indicate which pharmacies they receive the vitamins and modulators from, and how they obtain the refills (E.g., Does the patient call for refills? Does the pharmacy send a reminder text/email/phone call or are medications auto refilled?) During the first visit, directions on how to download the Patch App and scan the QRS code will be sent to the subject/parent. Subjects/parents will enter their recommended dose of Trikafta and vitamin in the Patch App. Patients will be taught how to place the Patch Cap in the lid of their vitamin bottle. They will be given the option of entering data for a "buddy" who will also get a reminder when they are due to take their medications if medications are not documented as taken in a specified time window. Data which will be collected at baseline are age (< 18 years of age, > 18 years of age), gender, insurance status, Education level (parent education level if patient < 18 years of age), marital status if patient > 18 years of age, weight/BMI/FEV1 at enrollment, concomitant medications, and vitamin A and E levels measured within the previous year. Once the patient is enrolled, the study team will contact the pharmacies from which the patient gets the vitamins and elexacaftor/tezacaftor/ivacaftor and will review the refill history over the past 6 months. The study staff will calculate the Medication Possession Ration (MPR) equal to the number of pills the patient would have based on their refill history/number of pills needed to take medication as prescribed. Over the next 3 months, patients will take their medications and this activity will either be logged via the Patch Cap electronically to the Patch App or the patient will enter the data every time they take the elexacaftor/tezacaftor/ivacaftor on the Patch App. This information will simultaneously be tracked in the Patch Hub by Patch Technologies personnel. At the end of three months, patients will return to clinic for their routine quarterly visit. Patients will be surveyed about ease of use of the Patch Cap and the PatchRx App, as well as estimating their adherence. The study team will obtain the refill history for vitamins and elexacaftor/tezacaftor/ivacaftor for the previous 3 months as reported by the pharmacy and calculate the MPR. Patch Technologies will provide adherence data collected through the Patch App to the PI at the end of the study.

Being tested
Patch Cap, Patch App
Medical subject headings
Cystic Fibrosis, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patch CapDevice

    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.

  • Patch AppDevice

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

Study groups in NCT04684823
Study groupRoleWhat they receive
Use of Patch Cap and Patch AppExperimentalSubjects will use Patch Technologies to track their medication regimen compliance
Receives: Device: Patch Cap; Device: Patch App

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline to 90 days

  2. 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

    Measured: Baseline to 90 days

Secondary outcomes (3)
  1. Patch vs Self Reported Adherence for Trikafta

    Difference between patch cap and app measurement vs self reported adherence

    Measured: Baseline to 90 days

  2. Patch vs Self Reported Adherence for Multivitamin

    Difference between patch cap and app measurement vs self reported adherence

    Measured: Baseline to 90 days

  3. Median Dosing Interval

    Difference between median dosing interval for Trikafta using Patch App vs manufacturer recommended interval

    Measured: Baseline to 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2020
  2. Study start15 Jan 2021
  3. Primary completion27 Dec 2021
  4. Study completion27 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Model description
Single arm device pilot study
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04684823
Sponsor's protocol ID
HSC20200875H
Status last verified
Jan 2022
First submitted
21 Dec 2020
Last updated
4 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Patch Cap and Patch App in people with Cystic Fibrosis and Adherence, Medication, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence to Trikafta dosing (time frame: Baseline to 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in