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.
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
- Type of treatment
- Pill or oral medicine, Medical device
- 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
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.
- Conditions
- Cystic Fibrosis, Adherence, Medication
- 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 group | Role | What they receive |
|---|---|---|
| Use of Patch Cap and Patch App | Experimental | Subjects 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.
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
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)
Patch vs Self Reported Adherence for Trikafta
Difference between patch cap and app measurement vs self reported adherence
Measured: Baseline to 90 days
Patch vs Self Reported Adherence for Multivitamin
Difference between patch cap and app measurement vs self reported adherence
Measured: Baseline to 90 days
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.
- First posted28 Dec 2020
- Study start15 Jan 2021
- Primary completion27 Dec 2021
- Study completion27 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Patch Rx Technologies
- Responsible party
- Sponsor
- Investigators
- Donna Beth J Willey-Courand, MD, Principal investigator, The University of Texas Health Science Center at San AntonioSarah J Kubes, Pharm D, Principal investigator, The University of Texas Health Science Center at San Antonio
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Patch Rx Technologies on Adherence to Vitamin and Trikafta® (Elexacaftor/Tezacaftor/Ivacaftor) Therapies in Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT04684823
- Acronym / sponsor ID
- HSC20200875H
- Conditions
- Cystic Fibrosis, Adherence, Medication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Patch Rx Technologies
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 27 Dec 2021 (actual)
- Study completion
- 27 Dec 2021 (actual)
- First posted
- 28 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm device pilot study
| Arm | Type | Receives |
|---|---|---|
| Use of Patch Cap and Patch App | Experimental | Device: Patch Cap, Device: Patch AppSubjects will use Patch Technologies to track their medication regimen compliance |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 1) Patient is already using some other medication therapy management (MTM) service.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patch CapA prescription container cap to track the dispensing of an oral dose of medication with an associated app which tracks the adherence to medication regimen. | Device | Use of Patch Cap and Patch App |
| Patch AppA mobile app that is used with Patch Cap to track adherence to medication regimen | Device | Use of Patch Cap and Patch App |
Primary outcome
Adherence to Trikafta dosing
Time frame: Baseline to 90 days
Tracking of medication compliance over the time where the Patch Cap and Patch App are used by determining number of days compliance
Adherence to Multivitamin dosing
Time frame: Baseline to 90 days
Tracking of medication compliance over the time where the Patch Cap and Patch App are used by determining number of days compliance
3 secondary outcomes
Patch vs Self Reported Adherence for Trikafta
Time frame: Baseline to 90 days
Patch vs Self Reported Adherence for Multivitamin
Time frame: Baseline to 90 days
Median Dosing Interval
Time frame: Baseline to 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna Beth J Willey-Courand, MD principal investigator
The University of Texas Health Science Center at San Antonio
Sarah J Kubes, Pharm D principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
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.