Cystic FibrosisNCT02301377
Exploring Novel Interventions to Improve Adherence in Children With Cystic Fibrosis
A study testing Spiro PD personal spirometer in people with Cystic Fibrosis, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Spiro PD personal spirometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Age less than 10 years or greater than 21 years
- Clinically unstable
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Spiro PD personal spirometer
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spiro PD personal spirometerDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
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
Measured: 3 months
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aarti Shakkottai, University of Michigan
- Investigators
- Aarti Shakkottai, MD, Principal investigator, University of MichiganSamya Nasr, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301377
- Sponsor's protocol ID
- HUM00080071
- Status last verified
- Jun 2015
- First submitted
- 21 Nov 2014
- Last updated
- 16 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Novel Interventions to Improve Adherence in Children With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02301377
- Acronym / sponsor ID
- HUM00080071
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 25 Nov 2014 (estimated)
- Results
- Posted 16 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Device: Spiro PD personal spirometerParticipants 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. |
| 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. |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Age less than 10 years or greater than 21 years
- Clinically unstable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spiro PD personal spirometer | Device | Intervention Group |
Primary outcome
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.
2 secondary outcomes
Cystic Fibrosis Questionnaire-Revised (CFQ-R)Treatment Burden Domain Score (Child)
Time frame: 3 months
Cystic Fibrosis Questionnaire-Revised (CFQ-R) Treatment Burden Domain Score (Parent)
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aarti Shakkottai, MD principal investigator
University of Michigan
Samya Nasr, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spiro PD personal spirometer in people with Cystic Fibrosis, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2015.