Early Detection of Pulmonary Exacerbations in Non-cystic Fibrosis Bronchiectasis

NCT06151366 | Not Yet Recruiting

• 2 other identifiers: P03012323297
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the use of equipment to monitor health at home in participants who have non-cystic fibrosis bronchiectasis. The main question\[s\] it aims to answer are:

• How acceptable participants find using home monitoring equipment.
• To find out if the data collected from home monitoring can help to detect chest infections (exacerbations) before participants get symptoms they are aware of. Participants will be provided with -
• a handheld spirometer to record FEV1 (lung function)
• a Fitbit, or other compatible activity monitor, to record activity and heart rate
• a saturation monitor that fits painlessly on the end of the finger to record oxygen levels
• weighing scales to record weight
• a mini freezer and pre-labelled sample containers to store a daily sputum sample. There is enough room in the freezers for samples to be brought to routine clinic visits. We will provide a cool bag and freezer packs for this. A courier collection of the samples can be arranged if necessary. Participants will be encouraged to perform lung function, activity and oxygen levels at least 4 x per week. Participants will be guided through how to set up and use each piece of equipment by the research team. The devices all connect to a smartphone app called Breathe RM (Remote Monitor,) which is free to download, via Bluetooth. Once set up using the home monitoring devices and adding notes to the app should take no more than 15 minutes per day. Participants will be asked to record in the app -
• episodes of pulmonary exacerbation that require antibiotic treatment
• their coughing and wellness scores daily

Conditions

Non-cystic Fibrosis Bronchiectasis

Outcome Measures

Primary Outcomes (1)

• The change from baseline in the bronchiectasis impact measure scores at 6 months compared to baseline

  The Bronchiectasis Impact Measure is a validated, patient reported outcome measure across 8 domains (cough, sputum, breathlessness, tiredness, activity, general health, control, exacerbations) and the impact they have on daily life. It is measured on a scale on 0 to 10 with 0 being no impact on daily life and 10 being greatly impacts daily life (lower score better). Minimum score 0 maximum score 10. Higher score mean worse outcome.

  baseline and month 6

Secondary Outcomes (2)

• The acceptability of home monitoring in participants with non-cystic fibrosis bronchiectasis

  3 months and 6 months

• Impact of home monitoring on acute exacerbation frequency

  In preceding 12 months and at 6 months

Interventions

non interventional OTHER

non interventional

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Under the care of the Lung Defence Clinic at Royal Papworth Hospital * CT confirmed diagnosis of bronchiectasis * Age \>/= 18 years * Had two or more clinician defined APEs in the year prior to enrolment * Typically expectorates sputum daily

You may qualify if:

• Under the care of the Lung Defence Clinic at Royal Papworth Hospital
• CT confirmed diagnosis of bronchiectasis
• Age \>/= 18 years
• Had two or more clinician defined APEs in the year prior to enrolment
• Typically expectorates sputum daily
• Considered suitable for home monitoring in the opinion of the investigator
• Able to provide written informed consent

You may not qualify if:

• Patients unable to provide written informed consent
• Known cystic fibrosis
• Lung transplant recipients or on lung transplant waiting list
• Use of long-term oxygen therapy (LTOT) or non-invasive ventilation to manage respiratory failure
• Patients unwilling to consent to their link anonymised data from home monitoring being used for research
• Patients unable to use a smartphone. Patients who would like to take part but do not have a smartphone can be provided with one.
• Patients who do not have reliable Wi-Fi at home or are unable to access public Wi-Fi at least twice per week.
• Considered unsuitable for home monitoring in the opinion of the investigator

Sponsors & Collaborators

• Papworth Hospital NHS Foundation Trust: lead
• LifeArc: collaborator

Study Sites (1)

Royal Papworth Hospital

Cambridge, Cambridgeshire, CB2 0AA, United Kingdom

Location

Central Study Contacts

Lucy Gale

CONTACT

01223638480; lucy.gale1@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: November 30, 2023
• Study Start: March 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Locations

GB (1)