- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02301377
Exploring Novel Interventions to Improve Adherence in Children With Cystic Fibrosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a randomized controlled trial to assess the impact of home lung function monitoring and medication reminders on adherence, clinical outcomes and quality of life in children with cystic fibrosis (CF) who are between 10 and 21 years of age.
Participants will be randomly assigned to either an intervention group or a control group. Those in the intervention group will receive a personal spirometer device that provides medication reminders and allows for lung function monitoring at home. The control group will receive the current standard of care. All participants will be aware that their adherence is being monitored over the course of the study using prescription refill data. Changes in lung function, body mass index and rate of hospitalization will be used as measures of clinical outcome. Responses to age-appropriate well-validated patient questionnaires will be used to assess the impact of the investigators interventions on quality of life and perceptions of treatment burden.
Since this device has never been previously studied in this patient population, the investigators would like to do a pilot study with 5 patients (3 in the intervention group and 2 in the control group) over a 3-month period to determine feasibility. This will also help us with the investigator power calculations and ultimately deciding the number of participants that will be needed for the larger study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intervention Group
Participants will receive a Spiro PD personal spirometer that will allow them to measure their lung function at home and provide medication reminders.
Participants will be instructed to use the device to check their lung function once a week.
They will also be asked to use the medication reminder feature of their device daily.
Participants in this group will receive a telephone call once a week from the research team to review lung function results and answer questions.
All participants need to fill out a quality of life questionnaire at the time of enrollment and at the end of the study.
Participants will be asked to sign a release form so their pharmacies can be contacted for prescription refill data to monitor adherence over the course of the study.
All participants will be asked to come to their quarterly clinic visits with their pediatric pulmonologist where their height, weight, body mass index, lung function and frequency of hospitalizations will be assessed.
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No Intervention: Control
Participants will be asked to fill out a quality of life questionnaire at the time of enrollment and at the end of the study.
All participants will be asked to come to their quarterly clinic visits with their pediatric pulmonologist where their height, weight, body mass index, lung function and frequency of hospitalizations will be assessed.
All participants will be asked to sign a release form so their pharmacies can be contacted for prescription refill data to monitor adherence over the course of the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medication Adherence
Time Frame: 3 months
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Overall adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins based on prescription refill data.
The actual number of prescriptions of each of the three medications filled in the 3-month period was divided by the number that should have been filled based on the prescribed amount of each medication and that value was multiplied by a 100 to generate a percentage.
|
3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cystic Fibrosis Questionnaire-Revised (CFQ-R)Treatment Burden Domain Score (Child)
Time Frame: 3 months
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Response of the participants to the treatment burden domain of the CFQ-R at the end of 3 months
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3 months
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Cystic Fibrosis Questionnaire-Revised (CFQ-R) Treatment Burden Domain Score (Parent)
Time Frame: 3 months
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Response of the parents/caregivers to the treatment burden domain of the CFQ-R at the end of 3-months
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3 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aarti Shakkottai, MD, University of Michigan
- Principal Investigator: Samya Nasr, MD, University of Michigan
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00080071
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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