- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02399241
Using Remote Telemonitoring to Detect Early Decline in Lung Function & Streamline Clinics in Adults With Cystic Fibrosis (RIGHT-CF)
June 21, 2017 updated by: Sheffield Teaching Hospitals NHS Foundation Trust
Lung Health research study (Development of a predictive model) - To determine whether the I-neb breathing parameters (flow data) can act as a surrogate marker for lung function (Forced Expiratory Volume in 1 second FEV1) hence allow early detection of decline in lung function in cystic fibrosis patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
- Initial phase of the study will involve retrospective data collection, to review 36 months of retrospectively collected clinic time data (i.e. total length of appointment, length of time seen by each discipline, waiting time). This data is routinely collected and displayed in run charts. It will be used to allow an understanding of the baseline variability in a standard un-streamed clinic and whether distinct patient sub-populations can be identified i.e. red (complicated and time consuming) and green (simple and rapidly processed) streams. These data may suggest a starting structure for clinic slot lengths and provide a baseline comparator for the subsequent bespoke clinic structures.
- In the prospective intervention phase, To recruit 50 participants to take part in the bespoke clinics using a home spirometer, weighing scales, and Bluetooth enabled I-neb providing breathing parameter and adherence data.
- Participants' baseline routinely collected demographics (age, gender, genotype) and clinical data (including comorbidities, number of intravenous antibiotic days and clinic attendances per year, and treatment regime) will be recorded.
- At baseline participants will be asked to complete the Patient Activation Measure questionnaire. This patient-reported measure is a powerful reliable tool which has been validated in the UK24. It involves 13 quick questions to identify a patient's knowledge, skills, and confidence in managing their own health and health care.
- Participants will be asked to measure lung function and weight one week prior to clinic. The I-neb adherence and flow data will be routinely captured and transferred.
- Prior to clinic when this data is collected participants will be asked the EQ-5D-5L as before, if they require a repeat prescription, and whether there are any issues they would like to focus on when they attend for their consultation.
- This data will then be reviewed to determine which stream patients would be predicted to need to require. i.e. adherence support, diagnostic, or stable brief review.
- Following review the standard clinic process will be analysed to see whether the streaming would have been appropriate and if it could have potentially saved time and resources.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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South Yorkshire
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Sheffield, South Yorkshire, United Kingdom, S5 7AU
- Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with a confirmed diagnosis of cystic fibrosis via genetic testing
- Patients aged 16 and above
- Patients using inhaled mucolytics (to loosen secretions) or antibiotic treatments via the I-neb for all or part of their treatment
- Patients who have capacity to give informed consent
Exclusion Criteria:
- Patients with a lung transplant
- Patients on the active transplant list
- Patients who are pregnant (due to the variability of lung function during pregnancy)
- Patients in the palliative end stage of their life
- Patients using inhaled treatments with no objective adherence measure
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Remote telemonitoring of clinical data
Bluetooth enabled nebuliser device (I-neb) providing breathing parameters and adherence data.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Forced Expiratory Volume in 1 second
Time Frame: Baseline to 6 months
|
The study will develop a predictive model and conduct a parallel service improvement project.
It therefore does not have a specific primary outcome measure.
The predictive model will be attempting to identify if there is a correlation between the I-neb breathing parameters (i.e.
inhalation time, rest time) and lung function (Forced Expiratory Volume in 1 second FEV1).
The clinic streaming will attempt to identify if the preclinic data (lung function, weight, adherence) can predict the clinic needs of a patient.
|
Baseline to 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Rachael Curley, MB ChB MRCP, Sheffield Teaching Hospitals NHS Foundation Trust
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Actual)
March 1, 2017
Study Completion (Actual)
March 1, 2017
Study Registration Dates
First Submitted
March 17, 2015
First Submitted That Met QC Criteria
March 20, 2015
First Posted (Estimate)
March 26, 2015
Study Record Updates
Last Update Posted (Actual)
June 22, 2017
Last Update Submitted That Met QC Criteria
June 21, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STH18185
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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