Exploring Novel Interventions to Improve Adherence in Children With Cystic Fibrosis
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 10 - 21 |
| Updated: | 7/25/2015 |
| Start Date: | November 2014 |
| End Date: | October 2015 |
| Contact: | Dawn Kruse |
| Email: | dmkruse@med.umich.edu |
| Phone: | 734-615-3266 |
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.
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.
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. The study duration will be one-year.
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.
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. The study duration will be one-year.
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.
Inclusion Criteria:
1. Age 10-21 years
2. Confirmed diagnosis of cystic fibrosis (CF) either by a sweat chloride ≥ 60mEq/L or
the presence of two disease-causing mutations
3. Patients must be clinically stable with at least 1 month from their last
hospitalization or use of oral antibiotics for a pulmonary exacerbation
4. Signed informed consent from the patient and/or from the parent/legal guardian, if
younger than 18 years.
Exclusion Criteria:
1. Age less than 10 years or greater than 21 years
2. Clinically unstable
We found this trial at
1
site
University of Michigan The University of Michigan was founded in 1817 as one of the...
Click here to add this to my saved trials
