Ignite Creation Date:
2024-05-06 @ 3:51 AM
Last Modification Date:
2024-10-26 @ 11:40 AM
Study NCT ID:
NCT02399241
Status:
COMPLETED
Last Update Posted:
2017-06-22
First Post:
2015-03-17
Brief Title:
Using Remote Telemonitoring to Detect Early Decline in Lung Function Streamline Clinics in Adults With Cystic Fibrosis
Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Organization:
Sheffield Teaching Hospitals NHS Foundation Trust
Study Overview
Official Title:
Using Remote Telemonitoring to Detect Early Decline in Lung Function Streamline Clinics in Adults With Cystic Fibrosis
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RIGHT-CF
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 ie 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 ie 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 patients 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 ie 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
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 patients 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None