Exploring Novel Interventions to Improve Adherence in Children With Cystic Fibrosis

NCT02301377 | Completed Results

• 1 other identifier: HUM00080071
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Cystic Fibrosis Questionnaire-Revised (CFQ-R)Treatment Burden Domain Score (Child)

  3 months

• Cystic Fibrosis Questionnaire-Revised (CFQ-R) Treatment Burden Domain Score (Parent)

  3 months

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

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.

Interventions

Spiro PD personal spirometer DEVICE

Intervention Group

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Age less than 10 years or greater than 21 years
• Clinically unstable

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Results Point of Contact

• Title: Dr. Aarti Shakkottai
• Organization: University of Michigan

aartik@med.umich.edu

734-764-4123

Study Officials

• Aarti Shakkottai, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Samya Nasr, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Fellow, Division of Pediatric Pulmonology

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: November 25, 2014
• Study Start: November 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: July 16, 2015
• Results First Posted: July 16, 2015

Record last verified: 2015-06

Locations

US (1)