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Trial record 2 of 16 for:    Cystic fibrosis sheffield

Using Remote Telemonitoring to Detect Early Decline in Lung Function & Streamline Clinics in Adults With Cystic Fibrosis (RIGHT-CF)

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ClinicalTrials.gov Identifier: NCT02399241
Recruitment Status : Completed
First Posted : March 26, 2015
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE March 17, 2015
First Posted Date  ICMJE March 26, 2015
Last Update Posted Date June 22, 2017
Study Start Date  ICMJE May 2015
Actual Primary Completion Date March 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using Remote Telemonitoring to Detect Early Decline in Lung Function & Streamline Clinics in Adults With Cystic Fibrosis
Official Title  ICMJE Using Remote Telemonitoring to Detect Early Decline in Lung Function & Streamline Clinics in Adults With Cystic Fibrosis
Brief Summary 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.
Detailed Description
  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Cystic Fibrosis
Intervention  ICMJE Device: Bluetooth enabled nebuliser device (I-neb)
Study Arms  ICMJE Experimental: Remote telemonitoring of clinical data
Bluetooth enabled nebuliser device (I-neb) providing breathing parameters and adherence data.
Intervention: Device: Bluetooth enabled nebuliser device (I-neb)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 20, 2015)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 1, 2017
Actual Primary Completion Date March 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02399241
Other Study ID Numbers  ICMJE STH18185
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sheffield Teaching Hospitals NHS Foundation Trust
Study Sponsor  ICMJE Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rachael Curley, MB ChB MRCP Sheffield Teaching Hospitals NHS Foundation Trust
PRS Account Sheffield Teaching Hospitals NHS Foundation Trust
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP