Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04684823 |
| Other study ID # |
HSC20200875H |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 15, 2021 |
| Est. completion date |
December 27, 2021 |
Study information
| Verified date |
January 2022 |
| Source |
The University of Texas Health Science Center at San Antonio |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
