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| ID | Type | Description | Link |
|---|---|---|---|
| M.O.M.M.I.1 | Registry Identifier | M.O.M.M.I.PBRN |
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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adherence dashboard motivational interviewing | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Remotely Observed Therapy | Doses of medication as recorded by bluetooth device | 140 days |
| Measure | Description | Time Frame |
|---|---|---|
| Morisky Adherence Questionnaire | Changes in self reported adherence | 140 days |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with cystic fibrosis over age 8 with difficulties with adherence to aerosolized Caysotn
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| Name | Affiliation | Role |
|---|---|---|
| Chris Landon, MD | Landon Pediatric Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Diagnostic Center | Ventura | California | 93003 | United States |
Will be made available to other users of PARI blue tooth monitoring
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D001398 | Aztreonam |
| ID | Term |
|---|---|
| D008997 | Monobactams |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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|
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |