Cystic Fibrosis Treatment Adherence
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 12 - 30 |
| Updated: | 2/7/2015 |
| Start Date: | October 2014 |
| End Date: | December 2016 |
| Contact: | Chris Landon, MD |
| Email: | chris.landon@ventura.org |
| Phone: | 8056526255` |
Cystic Fibrosis Treatment Adherence Cayston Proof-of-Concept Pilot 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.
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 an open-label, randomized (1:1) cross-over study involving a
28-day baseline (Phase 1), a 56-day treatment period with either enhanced adherence feedback
or standard of care (Phase 2), and a 56-day cross-over period in which groups switch to
either enhanced adherence feedback or standard of care (Phase 3). During Phase 1, Phase 2b
(the second 28 days of Phase 2) and Phase 3b (the second 28 days of Phase 3), subjects will
be treated with Cayston.
28-day baseline (Phase 1), a 56-day treatment period with either enhanced adherence feedback
or standard of care (Phase 2), and a 56-day cross-over period in which groups switch to
either enhanced adherence feedback or standard of care (Phase 3). During Phase 1, Phase 2b
(the second 28 days of Phase 2) and Phase 3b (the second 28 days of Phase 3), subjects will
be treated with Cayston.
Inclusion Criteria:
- Subjects will be 40 non-adherent CF patients
- Stratified by age as 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. -
Exclusion Criteria:
- Inability to give informed consent or assent
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