The SENSOR Study: A Mixed-methods Study of SElf-management Checks to Predict exacerbatioNs of Pseudomonas Aeruginosa in Patients With Long-term reSpiratORy Conditions

NCT02458807 | Completed

• 1 other identifier: PHT/2014/22
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The World Health Organisation predicts that lung disease will be the World's third largest killer in the future. This research project is looking to see whether the concept of a "home hospital" using the latest gadgets and iPad technology, can help patients stay well and out of hospital. Portsmouth Hospitals Trust is collaborating with a Company based in the United Kingdom (UK) who has developed a test to predict when people with lung diseases, such as; asthma, COPD and bronchiectasis, who regularly have chest infections, are about to become poorly with another infection - a form of early warning system. The investigators hope that the test will eventually be able to be used by the patient at home daily, to help self-manage their condition. The test measures whether bacteria are present, in sputum, and in what quantity. This information can be used by the patient's healthcare team to consider providing treatment earlier, thus controlling the infection sooner and reducing the patient's symptoms so that patients can stay at home rather than being regularly admitted to hospital. Part of this "early warning system" that has been developed by the UK Company includes the daily measurement of a number of indicators of health. These are usually only measured in hospital or by a General Practitioner, but new devices have been made that are simple enough for everyone to use at home. The investigators will include 30 participants, with non-Cystic Fibrosis (CF) chronic respiratory conditions who will be asked to take daily measurements of their blood pressure, temperature, weight and how well their heart and lungs are working with easy-to-use devices. They will also measure their physically activity with an activity tracker and report their wellness and whether they have taken medication daily. Participants will also be asked to collect a sample of sputum and urine each morning. Taking the samples and measurements should only take between 5-15 minutes each day to carry out. The sputum and urine will be tested at the hospital and will be recorded and analysed, so that the researchers can learn what happens well before a person with these conditions falls sick and needs hospitalisation.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Asthma; Bronchiectasis

Outcome Measures

Primary Outcomes (1)

• Exacerbation

  An exacerbation will be defined as the initiation of antimicrobial therapy for respiratory symptoms either at home or on admission, with or without concomitant steroids or admission. For patients who are already on continuous antibiotics, an exacerbation will be defined as starting a course of different antibiotics due to increased symptoms, or an increase or dose or frequency.

  6 months

Secondary Outcomes (1)

• Treatment Efficacy

  6 months

Eligibility Criteria

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

Study Population

Patients who are self-managing chronic respiratory conditions (apart from CF), and are colonised with either PA or HI and are prone to exacerbation.

You may qualify if:

• Male or Female, aged 18 years or above.
• Diagnosed with at least one (or a combination) of the following chronic respiratory conditions: asthma, COPD, non-CF bronchiectasis.
• Previous positive bacterial culture for PA or HI.
• Two or more exacerbations treated with antibiotics with the same pathogen within the last 12 months, one of which must have been within the last 6 months.
• Has been exacerbation free for the previous 4 weeks.
• Producing at least 1ml of sputum daily.
• Must be capable of operating the self-monitoring devices and tablet-based IT system, or have a carer capable of undertaking the measurements and collection, storage and transport of samples.
• Participant is willing and able to give informed consent for participation in the study.

You may not qualify if:

• A suspected or confirmed diagnosis of Cystic Fibrosis
• Any condition likely to limit participant survival or adherence during the study period in the judgement of the clinician, for example malignancy, cirrhosis of the liver.
• Currently taking part in any other research study.

Sponsors & Collaborators

• Portsmouth Hospitals NHS Trust: lead
• University of Portsmouth: collaborator

Study Sites (1)

Portsmouth Hospitals NHS Trust, Queen Alexandra Hospital

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

Related Publications (3)

• Pasteur MC, Bilton D, Hill AT; British Thoracic Society Bronchiectasis non-CF Guideline Group. British Thoracic Society guideline for non-CF bronchiectasis. Thorax. 2010 Jul;65 Suppl 1:i1-58. doi: 10.1136/thx.2010.136119.

  PMID: 20627931 BACKGROUND

• Murphy TF. The many faces of Pseudomonas aeruginosa in chronic obstructive pulmonary disease. Clin Infect Dis. 2008 Dec 15;47(12):1534-6. doi: 10.1086/593187. No abstract available.

  PMID: 19025364 BACKGROUND

• Xie Y, Redmond SJ, Mohktar MS, Shany T, Basilakis J, Hession M, Lovell NH. Prediction of chronic obstructive pulmonary disease exacerbation using physiological time series patterns. Annu Int Conf IEEE Eng Med Biol Soc. 2013;2013:6784-7. doi: 10.1109/EMBC.2013.6611114.

  PMID: 24111301 BACKGROUND

Related Links

• NICE Quality Standard for Asthma
• NICE Chronic obstructive pulmonary disease quality standard

Biospecimen

Retention: SAMPLES WITH DNA

Daily sputum and urine samples have been collected for study analysis. However we do not plan to extract DNA.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma; Bronchiectasis

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Prof Anoop Chauhan

  Portsmouth Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 1, 2015
• Study Start: August 18, 2014
• Primary Completion: February 28, 2015
• Study Completion: February 28, 2015
• Last Updated: September 30, 2022

Record last verified: 2022-06

Locations

GB (1)