Exploring Novel Interventions to Improve Adherence in Children With Cystic Fibrosis
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|ClinicalTrials.gov Identifier: NCT02301377|
Recruitment Status : Completed
First Posted : November 25, 2014
Results First Posted : July 16, 2015
Last Update Posted : July 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Device: Spiro PD personal spirometer||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Exploring Novel Interventions to Improve Adherence in Children With Cystic Fibrosis|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||March 2015|
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.
Device: Spiro PD personal spirometer
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.
- Medication Adherence [ Time Frame: 3 months ]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.
- Cystic Fibrosis Questionnaire-Revised (CFQ-R)Treatment Burden Domain Score (Child) [ Time Frame: 3 months ]Response of the participants to the treatment burden domain of the CFQ-R at the end of 3 months
- Cystic Fibrosis Questionnaire-Revised (CFQ-R) Treatment Burden Domain Score (Parent) [ Time Frame: 3 months ]Response of the parents/caregivers to the treatment burden domain of the CFQ-R at the end of 3-months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301377
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Aarti Shakkottai, MD||University of Michigan|
|Principal Investigator:||Samya Nasr, MD||University of Michigan|