N/A Completed N=5 Randomized Health Services Research

Exploring Novel Interventions to Improve Adherence in Children With Cystic Fibrosis

Cystic fibrosis

Source: ClinicalTrials.gov NCT02301377 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2015

Primary outcomePrimary: Medication Adherence — 91.6; 100 Percent Adherence

Summary

The investigators know that adherence to medications in children with cystic fibrosis (CF) is poor. Forgetfulness has often been reported as a barrier to adherence by both CF patients and their parents. Many of the investigators patients also report being motivated by the results of their lung function studies (PFTs) to stay adherent to their medications. In this study, the investigators would like to see if providing medication reminders and allowing patients to measure their lung function at home will lead to better adherence. This will be a pilot study to determine the feasibility of providing such as a device to children with CF.

Outcome Measures

Outcome	Result	p-value
PRIMARY Medication Adherence	91.6; 100	—
SECONDARY Cystic Fibrosis Questionnaire-Revised (CFQ-R)Treatment Burden Domain Score (Child)	81.66; 72.5	—
SECONDARY Cystic Fibrosis Questionnaire-Revised (CFQ-R) Treatment Burden Domain Score (Parent)	67; 66.5	—

Eligibility Criteria

Inclusion Criteria

Age 10-21 years
Confirmed diagnosis of cystic fibrosis (CF) either by a sweat chloride ≥ 60mEq/L or the presence of two disease-causing mutations
Patients must be clinically stable with at least 1 month from their last hospitalization or use of oral antibiotics for a pulmonary exacerbation
Signed informed consent from the patient and/or from the parent/legal guardian, if younger than 18 years.

Exclusion Criteria

Age less than 10 years or greater than 21 years
Clinically unstable

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02301377). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.