Exploring Novel Interventions to Improve Adherence in Children With Cystic Fibrosis

NCT ID: NCT02301377

Last Updated: 2015-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-03-31

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.

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Spiro PD personal spirometer

Intervention Type: DEVICE

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Spiro PD personal spirometer

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Aarti Shakkottai

Clinical Fellow, Division of Pediatric Pulmonology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aarti Shakkottai, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Samya Nasr, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00080071

Identifier Type: -

Identifier Source: org_study_id