Cystic FibrosisNCT02179710
Cystic Fibrosis Treatment Adherence Cayston Proof-of-Concept Pilot Study
An observational study of Cystic Fibrosis, run by Landon Pediatric Foundation at 1 site in United States.
Trial summary
Real-world adherence to inhaled and oral therapies for cystic fibrosis (CF) patients remains discouragingly low, ranging between 31-53% for inhaled antibiotics and 41-72% for hypertonic saline. Read more about this study
- Who is it for?
- Ages 8 to 60 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Adherence dashboard motivational interviewing
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Sep 2016
- Phase
- Observational
- 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 8 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with cystic fibrosis over age 8 with difficulties with adherence to aerosolized Caysotn
Who may be able to join
- Subjects will be 18 non-adherent CF patients
- Stratified by age as adult supervised (8-12) adolescents (12-18) and young adults (19-30) and gender
- Balanced for ethnicity and disease severity -Non-adherence status will be determined at screening based on an MAQ score < 6. -
Who cannot join
- Inability to give informed consent or assent
Trial locations and contacts
1 site in 1 country.
United States1 site
Pediatric Diagnostic Center
Ventura, California, 93003
About this study
Real-world adherence to inhaled and oral therapies for cystic fibrosis (CF) patients remains discouragingly low, ranging between 31-53% for inhaled antibiotics and 41-72% for hypertonic saline. Programs to enhance adherence, including comprehensive behavioral interventions with adolescents, have met with mixed success. Advances in therapy, treatment delivery systems, and data capture technology offer the potential for enhancing adherence by providing immediate and more frequent feedback to the patient regarding his or her fidelity to the prescribed treatment regimen. We propose to conduct a proof-of-concept study to evaluate a systematic approach to linking treatment and feedback components to enhance adherence.
Read the detailed description
Study Design: This will be a single group intervention involving a 28-day baseline (Phase 1), a 28-day treatment period with enhanced adherence feedback. Subjects will be treated with Cayston via a blue tooth enabled nebulizer.
- Conditions
- Cystic Fibrosis
- Being tested
- Adherence dashboard motivational interviewing
- Keywords
- adherence, cystic fibrosis, adolescents, adults
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherence dashboard motivational interviewingBehavioural
Also called PARI, Altera, Cayston
These data will be aggregated and displayed graphically in weekly intervals. Adherence will be displayed as percentage and timing percentage within a set criterion of prescribed inter-dose interval. Drug holidays, operationally defined as missing two or more consecutive doses will be displayed along with average length. Patient self-reported adherence information, collected via handheld (i.e, smart phone, tablet, laptop) application will be displayed as percentage and timing percentage on the dashboard. Review of dashboard weekly with investigator for motivational interviewing
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing | Review of adherence dashboard by the investigator with the patient to facilitate and engage intrinsic motivation within the client in order to change behavior. Receives: Behavioral: Adherence dashboard motivational interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remotely Observed Therapy
Doses of medication as recorded by bluetooth device
Measured: 140 days
Secondary outcomes (1)
Morisky Adherence Questionnaire
Changes in self reported adherence
Measured: 140 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startMar 2015
- Primary completionSep 2016
- Study completionSep 2016
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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Landon Pediatric Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Chris Landon, MD, Principal investigator, Landon Pediatric Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179710
- Sponsor's protocol ID
- M.O.M.M.I.1
- Other IDs
- M.O.M.M.I.1
- Status last verified
- Sep 2016
- First submitted
- 30 Jun 2014
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Will be made available to other users of PARI blue tooth monitoring
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cystic Fibrosis Treatment Adherence Cayston Proof-of-Concept Pilot Study
- ClinicalTrials.gov ID
- NCT02179710
- Acronym / sponsor ID
- M.O.M.M.I.1
- Conditions
- Cystic Fibrosis
- Keywords
- adherence, cystic fibrosis, adolescents, adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Landon Pediatric FoundationUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Mar 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 2 Jul 2014 (estimated)
- 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.
Real-world adherence to inhaled and oral therapies for cystic fibrosis (CF) patients remains discouragingly low, ranging between 31-53% for inhaled antibiotics and 41-72% for hypertonic saline. Programs to enhance adherence, including comprehensive behavioral interventions with adolescents, have met with mixed success. Advances in therapy, treatment delivery systems, and data capture technology offer the potential for enhancing adherence by providing immediate and more frequent feedback to the patient regarding his or her fidelity to the prescribed treatment regimen. We propose to conduct a proof-of-concept study to evaluate a systematic approach to linking treatment and feedback components to enhance adherence.
Detailed description
Study Design: This will be a single group intervention involving a 28-day baseline (Phase 1), a 28-day treatment period with enhanced adherence feedback. Subjects will be treated with Cayston via a blue tooth enabled nebulizer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing | – | Behavioral: Adherence dashboard motivational interviewingReview of adherence dashboard by the investigator with the patient to facilitate and engage intrinsic motivation within the client in order to change behavior. |
Who may qualify
- Ages
- 8 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with cystic fibrosis over age 8 with difficulties with adherence to aerosolized Caysotn
Key inclusion criteria (3 listed)
- Subjects will be 18 non-adherent CF patients
- Stratified by age as adult supervised (8-12) adolescents (12-18) and young adults (19-30) and gender
- Balanced for ethnicity and disease severity -Non-adherence status will be determined at screening based on an MAQ score < 6. -
Key exclusion criteria (1 listed)
- Inability to give informed consent or assent
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 |
|---|---|---|
| Adherence dashboard motivational interviewingAlso: PARI, Altera, CaystonThese data will be aggregated and displayed graphically in weekly intervals. Adherence will be displayed as percentage and timing percentage within a set criterion of prescribed inter-dose interval. Drug holidays, operationally defined as missing two or more consecutive doses will be displayed along with average length. Patient self-reported adherence information, collected via handheld (i.e, smart phone, tablet, laptop) application will be displayed as percentage and timing percentage on the dashboard. Review of dashboard weekly with investigator for motivational interviewing | Behavioural | Motivational Interviewing |
Primary outcome
Remotely Observed Therapy
Time frame: 140 days
Doses of medication as recorded by bluetooth device
1 secondary outcome
Morisky Adherence Questionnaire
Time frame: 140 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 8 Sep 2016.
- Individual participant dataSharing planned: Yes. Will be made available to other users of PARI blue tooth monitoring
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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.
Chris Landon, MD principal investigator
Landon Pediatric Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Landon Pediatric Foundation 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 3 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 8 Sep 2016. 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?
Remotely Observed Therapy (time frame: 140 days). 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 8 Sep 2016.