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

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Brief Title

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

Official Title

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

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.
    

Detailed Description

      The purpose of this study is 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.

      This trial is a single centre, non-randomised, mixed methods study. A longitudinal cohort of
      patients and their carers (where appropriate) will be asked to collect physiological,
      biological and disease outcome data over a 6 month period. Both participants and the
      clinicians responsible for patient care and will have no access to the longitudinal data and
      this information will not be used to make clinical decisions. The laboratory samples will
      also be analysed in a blinded manner. These data will then be analysed to develop a model for
      predicting onset of exacerbations which can be built into a self-monitoring system.

      Qualitative methods will be used to explore participant and carer experiences of using the
      technology and performing daily self-monitoring assessments. The expected duration of
      participant participation in the cohort will be six months, with an invitation to complete a
      self-administered questionnaire at baseline to inform a face to face semi-structured
      interview with patients with, or without carer joint participant at the end of the follow-up
      period (six months completion).

      A total of 30 male and female patients, aged 18 and over will be recruited;

      20 patients chronically infected with Pseudomonas Aeruginosa (PA):

      • 10 with asthma or COPD and 10 with non-CF bronchiectasis

      10 patients with no previously detected PA infection, infected with Haemophilus influenza
      (HI)

      The investigators will also recruit 10 patients plus/minus their carers from the PA group, 5
      patients plus/minus their carers from the HI group into the qualitative part of the study.

      Methodology:

      Potential participants will be recruited from existing asthma, COPD and non-CF bronchiectasis
      local patient databases in combination with the local laboratory results systems by the
      clinical care team. Potential participants identified will then be contacted by a member of
      the local research team who are also the routine clinical care team and invited to attend a
      specialist research recruitment clinic.

      At the research clinic participants will be reviewed by a clinical research fellow and
      screened for suitability for the study by the research team. Patients and carers will be able
      to view and try out the self-monitoring devices and tablet-based IT system. Capacity to
      operate these systems will be assessed as part of the screening. Those who meet eligibility
      criteria will be given a Participant Information Sheet and/or Carer information sheet if
      participants wish for their carer to assist them in using the self-monitoring devices and
      tablet-based IT system daily.

      After adequate time to consider and ask questions about the study, participants who are
      interested in taking part in the trial will be invited to a screening visit where they will
      be asked to sign a consent form.

      At the screening visit, following consent, participants' lung function, blood pressure,
      oxygen levels, height, weight and BMI will be recorded and general health questions will be
      asked to gain information on medical history, current medications & smoking status.
      Participants will also be asked to complete a set of baseline questionnaires.

      Following the screening visit (up to 10 days after), the research nurse and an technician
      from the company ASEPTIKA will deliver and install the study equipment into the participants
      home and train the participant on how to use all the technology provided. This training visit
      will take approximately 60 minutes.

      Over a period of 6 months, participants will be required to collect a sputum and urine sample
      daily and store them in the freezer provided, in their own homes. Participants will be
      trained in sample collection at the screening visit by a member of the research team. The
      samples will be collected from the participants monthly by the a member of the research team,
      or participants can bring the samples into hospital at their routine clinic appointments.
      Participants will also need to measure their weight, blood pressure, oxygen level and lung
      function and wear an activity monitor daily. These results, as well as a questionnaire, are
      recorded on the iPad which sends the data via 3G to a central database. The process should
      take no longer than 15 minutes a day. Participants and clinicians will be blind to the
      continuous data over the duration of the study but participants will see the values generated
      daily on the screens of the devices.

      During the study participants will attend their normal review with the medical team at 3 and
      6 months (study completion) which usually involves lung function, sputum sample for culture
      and clinical review. These visits will coincide with a short clinic visit to see the research
      team to complete disease specific and quality of life questionnaires as well as noting any
      changes to treatment and exacerbations.

      Participants and their carers will also have the opportunity to give additional consent to
      take part in a qualitative interview, at the same time as the main study consent is sought.
      If consent is attained, participants will be given an extra questionnaire to complete at
      baseline which will include questions on their expectations and desired outcomes of the
      study, worries, concerns and any foreseen barriers to compliance. Participants plus or minus
      their carers may then be selected and invited to take part in 1 semi-structured face-to-face
      interview, at the end of study (6 months) to discuss what they think about the study and also
      what they feel and understand about their health. The interviews will either be conducted at
      the participants' homes or at hospital, depending on their preference and will be conducted
      by the same research fellow throughout the study to allow consistency. The interviews will
      take approximately 45-60 minutes depending on what the participant/carer wishes to share. The
      interview can be terminated at any point the participant/carer wishes to stop and this will
      not influence their subsequent treatment.

      If participants are admitted to hospital during the course of the study they will be asked to
      take along their iPad and self-monitoring devices with them. If participants forget their
      iPad a member of the study team will visit the patient on the ward and will assist to collect
      the patient's daily measurements for the study where appropriate.
    


Study Type

Observational


Primary Outcome

Exacerbation

Secondary Outcome

 Treatment Efficacy

Condition

Chronic Obstructive Pulmonary Disease (COPD)



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

30

Start Date

August 2014

Completion Date

March 2017

Primary Completion Date

March 2015

Eligibility Criteria

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Prof Anoop Chauhan, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT02458807

Organization ID

PHT/2014/22


Responsible Party

Sponsor

Study Sponsor

Portsmouth Hospitals NHS Trust

Collaborators

 University of Portsmouth

Study Sponsor

Prof Anoop Chauhan, Principal Investigator, Portsmouth Hospitals NHS Trust


Verification Date

January 2017