Cystic FibrosisNCT04453358
Cystic Fibrosis Remote Monitoring System
A study testing InCourage-Connect and InCourage in people with Cystic Fibrosis, run by Koronis Biomedical Technologies.
Trial summary
The objective of this study is to determine if interactive technology (i.e. virtual coaching) that facilitates vest therapy goal setting and provides positive reinforcement will increase adherence to vest therapy for airway clearance in individuals with CF. Read more about this study
- Who is it for?
- Ages 14 to 85 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- InCourage-Connect and InCourage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have a diagnosis of cystic fibrosis
- Be physically capable of and willing to use the study device
- Access to an internet connection
- Access to a mobile device capable of using applications
- Be familiar with how to utilize a mobile device and/or applications
- Self-reported CF-related therapy adherence between 25%-75% on a screening questionnaire
Who cannot join
- History of solid-organ transplant
- Inability to speak and read the English language
- Any contraindication to vest use for airway clearance
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Cystic Fibrosis Remote Monitoring System to Support Resource-Limited Communities
The objective of this study is to determine if interactive technology (i.e. virtual coaching) that facilitates vest therapy goal setting and provides positive reinforcement will increase adherence to vest therapy for airway clearance in individuals with CF.
Read the detailed description
Cystic fibrosis (CF) is a life-limiting multi-system disease primarily characterized by chronic lung infections and pulmonary symptoms such as cough, dyspnea, and chest tightness. Those with CF rely on numerous pharmaceutical and treatment-based therapies as part of their routine care to maintain lung health. Airway clearance, one such treatment-based therapy, uses breathing techniques and various vibrating devices to mobilize lung secretions and is considered a cornerstone of CF care. Vest therapy, a "shaking vest" that applies pressure and high frequency vibrations to the chest wall is the most commonly used technique for airway clearance in the U.S., but adherence to recommended goals for airway clearance is low. Barriers to adherence include the time limitations and unclear goal setting for effective treatment. A previous pilot study by this research team showed that CF patients find the use of airway clearance vests equipped with both pre-set and individually determined programing capabilities as well as electronic monitoring and transmitting capabilities to be acceptable and feasible. Information such as vest-use time, vest pressure measures, programming choices and symptom reporting is captured by these devices and transmitted to health care teams for review as well as provided to patients to provide feedback on treatment goals. This study aims to determine if providing patients with clearly stated treatment goals and the means to monitor and receive positive reinforcing feedback on vest use through interactive technology (i.e. virtual coaching) will improve vest therapy adherence in individuals with CF.
- Conditions
- Cystic Fibrosis
- Being tested
- InCourage-Connect, InCourage
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InCourage-ConnectDevice
This intervention will provide patients with clearly stated treatment goals and provide them with interactive feedback based on usage date to help support airway clearance therapy adherence.
InCourageDevice
This intervention will provide standard of care airway clearance therapy with no interactive feedback on treatment goals and usage.
| Study group | Role | What they receive |
|---|---|---|
| Interactive coaching | Active comparator | Airway clearance therapy using goal setting and interactive feedback. Receives: Device: InCourage-Connect |
| Standard of care coaching | Active comparator | Standard of care airway clearance therapy. Receives: Device: InCourage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway Clearance Therapy Adherence
Intervention comparison of adherence measurements: a) to prescribed pressure based upon % of time at prescribed pressure and b) to prescribed duration of treatment based upon % of time using the airway clearance device at prescribed duration (weekly capture).
Measured: 90 days
Secondary outcomes (3)
Lung Function
Intervention comparison of pre and post measures of FEV1 and FVC.
Measured: 180 days
Quality of Life Measurement
Intervention comparison based upon pre and post Cystic Fibrosis Questionnaire Revised (CFQ-R).
Name of categories/domains CFQ-R:
9 Quality of life domains: Physical, role/school, vitality, emotion, social, body image, eating, treatment burden, health perceptions.
3 symptom scales: Weight, respiratory, and digestion.
Scaling of items:
5 distinct 4-point Likert scales (e.g., always/often/ sometime/never)
Scoring:
Scores for each domain; after recording, each item is summed to generate a domain score and standardized. Scores range from 0 to 100, with higher scores indicating better health.
Measured: 180 days
CF Respiratory Symptoms
Intervention comparison based upon pre and post CF Respiratory Symptom Score (CRSS) assessment.
The score evaluates four symptoms: cough, sputum, breathlessness and fatigue. Each symptom is scored from one (mild symptoms) to four (severe symptoms). The total symptom score was the summation of all the four symptoms.
Scores range from 4 to 16 with 4 being mild to 16 being most severe.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start1 Sep 2020 (estimated)
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a randomized-comparative study investigating the effectiveness of either low-level virtual coaching vs. high-level virtual coaching in improving airway clearance treatment adherence.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koronis Biomedical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Noah Lechtzin, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453358
- Sponsor's protocol ID
- R44MD010177
- Status last verified
- Jun 2020
- First submitted
- 24 Jun 2020
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cystic Fibrosis Remote Monitoring System to Support Resource-Limited Communities
- ClinicalTrials.gov ID
- NCT04453358
- Acronym / sponsor ID
- R44MD010177
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Koronis Biomedical TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- Johns Hopkins University
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 1 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine if interactive technology (i.e. virtual coaching) that facilitates vest therapy goal setting and provides positive reinforcement will increase adherence to vest therapy for airway clearance in individuals with CF.
Detailed description
Cystic fibrosis (CF) is a life-limiting multi-system disease primarily characterized by chronic lung infections and pulmonary symptoms such as cough, dyspnea, and chest tightness. Those with CF rely on numerous pharmaceutical and treatment-based therapies as part of their routine care to maintain lung health. Airway clearance, one such treatment-based therapy, uses breathing techniques and various vibrating devices to mobilize lung secretions and is considered a cornerstone of CF care. Vest therapy, a "shaking vest" that applies pressure and high frequency vibrations to the chest wall is the most commonly used technique for airway clearance in the U.S., but adherence to recommended goals for airway clearance is low. Barriers to adherence include the time limitations and unclear goal setting for effective treatment. A previous pilot study by this research team showed that CF patients find the use of airway clearance vests equipped with both pre-set and individually determined programing capabilities as well as electronic monitoring and transmitting capabilities to be acceptable and feasible. Information such as vest-use time, vest pressure measures, programming choices and symptom reporting is captured by these devices and transmitted to health care teams for review as well as provided to patients to provide feedback on treatment goals. This study aims to determine if providing patients with clearly stated treatment goals and the means to monitor and receive positive reinforcing feedback on vest use through interactive technology (i.e. virtual coaching) will improve vest therapy adherence in individuals with CF.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a randomized-comparative study investigating the effectiveness of either low-level virtual coaching vs. high-level virtual coaching in improving airway clearance treatment adherence.
| Arm | Type | Receives |
|---|---|---|
| Interactive coaching | Active comparator | Device: InCourage-ConnectAirway clearance therapy using goal setting and interactive feedback. |
| Standard of care coaching | Active comparator | Device: InCourageStandard of care airway clearance therapy. |
Who may qualify
- Ages
- 14 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Have a diagnosis of cystic fibrosis
- Be physically capable of and willing to use the study device
- Access to an internet connection
- Access to a mobile device capable of using applications
- Be familiar with how to utilize a mobile device and/or applications
Key exclusion criteria (3 listed)
- History of solid-organ transplant
- Inability to speak and read the English language
- Any contraindication to vest use for airway clearance
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 |
|---|---|---|
| InCourage-ConnectThis intervention will provide patients with clearly stated treatment goals and provide them with interactive feedback based on usage date to help support airway clearance therapy adherence. | Device | Interactive coaching |
| InCourageThis intervention will provide standard of care airway clearance therapy with no interactive feedback on treatment goals and usage. | Device | Standard of care coaching |
Primary outcome
Airway Clearance Therapy Adherence
Time frame: 90 days
Intervention comparison of adherence measurements: a) to prescribed pressure based upon % of time at prescribed pressure and b) to prescribed duration of treatment based upon % of time using the airway clearance device at prescribed duration (weekly capture).
3 secondary outcomes
Lung Function
Time frame: 180 days
Quality of Life Measurement
Time frame: 180 days
CF Respiratory Symptoms
Time frame: 180 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Noah Lechtzin, MD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing InCourage-Connect and InCourage in people with Cystic Fibrosis, run by Koronis Biomedical Technologies.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noah Lechtzin, MD ((410) 502-7044, nlechtz1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Airway Clearance Therapy Adherence (time frame: 90 days). 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 2 Jul 2020.