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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
Sponsor:
Information provided by (Responsible Party):
Aarti Shakkottai, University of Michigan

Brief 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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Device: Spiro PD personal spirometer Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

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.
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   10 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Aarti Shakkottai, MD University of Michigan
Principal Investigator: Samya Nasr, MD University of Michigan

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Responsible Party: Aarti Shakkottai, Clinical Fellow, Division of Pediatric Pulmonology, University of Michigan
ClinicalTrials.gov Identifier: NCT02301377     History of Changes
Other Study ID Numbers: HUM00080071
First Posted: November 25, 2014    Key Record Dates
Results First Posted: July 16, 2015
Last Update Posted: July 16, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
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Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases