Exploring Novel Interventions to Improve Adherence in Children With Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Exploring Novel Interventions to Improve Adherence in Children With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02301377
• Other study ID #: HUM00080071
• Status: Completed
• Phase: N/A
• First received: November 21, 2014
• Last updated: June 22, 2015
• Start date: November 2014
• Est. completion date: March 2015

Study information

• Verified date: June 2015
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 21 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Device:
• Spiro PD personal spirometer

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Adherence	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	No
Secondary	Cystic Fibrosis Questionnaire-Revised (CFQ-R)Treatment Burden Domain Score (Child)	Response of the participants to the treatment burden domain of the CFQ-R at the end of 3 months	3 months	No
Secondary	Cystic Fibrosis Questionnaire-Revised (CFQ-R) Treatment Burden Domain Score (Parent)	Response of the parents/caregivers to the treatment burden domain of the CFQ-R at the end of 3-months	3 months	No