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AsthmaNCT02774772

The Use of Home-monitoring and mHealth Systems to Predict Asthma Control and the Occurrence of Asthma Exacerbations

An observational study of Asthma, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators will collect a range of physiological, behavioural and environmental data using current mHealth and home-monitoring systems, environmental databases and patient characteristics, to determine to what extent asthma control and the occurrence of asthma exacerbations can be predicted. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma
How many people
150 participants
Where
1 siteUnited Kingdom
Study dates
Apr 2016to 31 Jul 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: One hundred and fifty patients with asthma will be recruited from outpatient clinics and from general practices in London, Manchester (United Kingdom) and Leiden (Netherlands).

Who may be able to join

  • Doctors-diagnosis of asthma with confirmation of asthma from one or more of the following tests in medical notes:
  • Reversibility of 12% and 200ml in a spirometry following administration of a bronchodilator medication ii) Peak flow monitoring for one week iii) Positive bronchial challenge
  • BTS asthma treatment step 2-4, for a minimum of 6 months in the previous year
  • A course of oral prednisone for a minimum of three days, or an emergency department visit/hospitalisation for asthma, in the previous twelve months. Or currently experiencing uncontrolled asthma (based on the result of the Asthma Control Questionnaire)

Who cannot join

  • Comorbidities that cause overlapping symptoms such as breathlessness, wheeze, cough or other interfering chronic condition (for example other symptomatic chronic respiratory disease, cardiac failure etc.).
  • Unable to understand English or Dutch, as appropriate

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • University Hospital of South Manchester

    Manchester, m23 9lt

Other trials in United Kingdom

About this study

The investigators will collect a range of physiological, behavioural and environmental data using current mHealth and home-monitoring systems, environmental databases and patient characteristics, to determine to what extent asthma control and the occurrence of asthma exacerbations can be predicted.

Read the detailed description

This observational study occurs alongside participants' normal asthma care. Participants will be asked to attend their normal GP and hospital appointments, and to continue to take their medication as determined by their usual healthcare team.

In addition to their normal care, participants will attend an induction visit and complete a 12-month home-monitoring period with 2 phases:

  • Phase 1: one-month period of daily monitoring of asthma
  • Phase 2: eleven-month period of weekly monitoring of asthma. Patients will be invited for a further 2-week period of daily monitoring between 2-9 months of Phase 2. The purpose of the second phase of daily monitoring is to assess the influence of seasonality (different seasons) on the patient's asthma. 0 xxxx 1 ------ 2 ------ 3 ------ 4 yy-- 5 ------ 6------ 7 ------ 8 ------ 9 ------ 10 ------ 11 ----- 12

Figure 1. Schematic of study design. 0 1 2.., months; xxxx, first series of 4 weeks daily monitoring; ------ 11 months weekly monitoring; yy--, example of second series of 2 weeks daily monitoring during month 5 (the timing of this 2 weekly phase will be randomised over month 2-9).

A variety of measurements will be made at an induction visit and over the 12-month home-monitoring period, as detailed below:

Induction visit

Demographics - Age (yr), gender, nationality, ethnicity, body mass (kg), height (cm), body mass index (BMI), comorbidities, medication, previous moderate and severe asthma exacerbations in preceding 12 months, previous severe asthma exacerbations requiring hospital attendance / admission (No in preceding 12 months), number of intensive care admission for asthma (ever), smoking history and social economic status.

Questionnaires

  • Asthma control will be assessed by the Asthma Control Questionnaire (ACQ). [A patient's asthma control status will be classified as Controlled (ACQ≤0.75), Partly Controlled (0.75<ACQ≤1.5) or Uncontrolled (ACQ>1.5)].
  • The typical diet of participants will be assessed via the Global Allergy and Asthma European Network (GA2LEN) food frequency questionnaire.
  • Sinusitis/rhinoconjunctivitis will be determined via the Sino-Nasal Outcome Test 22 (SNOT 22)
  • Anxiety and depression will be determined via the hospital anxiety and depression score (HADS)
  • Characteristics such as health directed behaviours and self-monitoring will be determined using the Health education impact Questionnaire (HeiQ)
  • Mini-Asthma Quality of Life Questionnaire (mini-AQLQ)

Clinical tests

  • Atopic status will be determined via previous skin-prick test or blood test results. (If a patient's atopic status is unknown, a standard skin-prick test or blood test will be conducted).
  • The diagnosis of asthma will be verified via a previous test result, using one of the following; a bronchodilator reversibility test, one-week peak flow monitoring or a bronchial challenge test. (If a patient's asthma diagnosis has not been verified from one of the tests listed above, they may be performed at screening visits)
  • Lung function (spirometry) will be conducted according to ERS guidelines
  • Airways inflammation will be determined by the level of Fractional exhaled Nitric Oxide (FeNO) according to established guidelines
  • Exhaled Breath Temperature, as measured by the X-halo device

Phase 1 (first 4-week daily monitoring)

The measurements in Phase 1 will be collected during the first 4 weeks of monitoring, and will be self-administered by the participant. Measurements will occur continuously, daily, weekly or less frequent, as specified below:

Questionnaires

  • Daily, Asthma Control Diary (ACD)
  • Daily, online medication diary
  • Weekly, assessment of the occurrence of exacerbation, determined by a custom questionnaire.
  • Monthly, mini Asthma Quality of Life Questionnaire (mini-AQLQ)
  • Sinusitis will be determine via the SNOT 22 at the end of the first 4-week daily monitoring
  • Technology acceptance via ASQ at the end of the first 4-week daily monitoring 25

Physiological monitoring

  • Continuous data collection, via wearable sensors
  • Pulse, exercise level via Fitbit HR wristband
  • Medication usage and adherence via Smartinhaler device in a subset of 60 participants
  • Measurement of breath rate via Spire device
  • Daily, twice daily home spirometry (FEV1) via Piko-1 device
  • Daily, twice-daily Fractional exhaled Nitric Oxide (FeNO) via NIOX-VERO device in a subset of 60 participants
  • Daily, twice-daily Exhaled Breath Temperature (EBT) via X-halo device, in a subset of 60 participants

Environmental

  • Retrospective collection of environmental conditions for patients home and work address, including:
  • Ozone (O3)
  • air pollution (PM10, PM2.5)
  • ambient temperature
  • Nitrous oxide (NO2)
  • Sulphur dioxide (SO2)
  • Weather conditions
  • Mean temperature
  • Humidity
  • Pollen counts

Phase 2 (month 2-12) The measurements in Phase 2 will occur continuously, weekly or less frequent, as specified below. The weekly measurements will occur on a fixed day of the week, determined by participants for convenience, and all the measurements will be self-administered by the participant.

Questionnaires

  • Weekly online Asthma Control Questionnaire
  • Weekly assessment of the occurrence of exacerbation, determined by a custom questionnaire.
  • Weekly, medication diary (custom made questionnaire)
  • Monthly mini Asthma Quality of Life Questionnaire (mini AQLQ)
  • Monthly, Sinus symptoms will be determine via the SNOT 22 questionnaire
  • Technology acceptance via ASQ at 6 and 12 months
  • Global Allergy and Asthma European Network (GA2LEN) food frequency questionnaire will be completed at the end of the study.

Physiological monitoring

  • Continuous data collection, via wearable sensors
  • Pulse, exercise level via Fitbit HR wristband
  • Medication usage and adherence via Smartinhaler device in a subset of 60 participants
  • Measurement of breath rate via Spire device
  • Weekly, home spirometry (FEV1) via Piko-1
  • Weekly, Fractional exhaled Nitric Oxide (FeNO) by NIOX-VERO in a subset of 60 participants
  • Weekly, Exhaled Breath Temperature (EBT) by X-halo, in a subset of 60 participants

Environmental

  • Retrospective collection of environmental conditions for patients home and work address, as detailed above.

A second series daily monitoring (as described in phase 1) will be performed over a two week period, randomised between 2 to 9 months.

Conditions
Asthma
Medical subject headings
Asthma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Asthma control using the asthma control diary

    A score of 0.0-0.75 is classified as well-controlled asthma; 0.75-1.5 as a partly controlled; and >1.5 as poorly controlled asthma.

    Measured: After 1 month

  2. Severe asthma exacerbations

    Severe asthma exacerbations are events that require urgent action on the part of the patient and physician to prevent a serious outcome, such as hospitalization or death from asthma. The occurrence of severe asthma exacerbations is an important marker of poor asthma control. Severe asthma exacerbations are defined by the occurrence of at least one of the following:

    • Use of systemic corticosteroids (tablets, suspension, or injection), or an increase from a stable maintenance dose, for at least 3 days. For consistency, courses of corticosteroids separated by 1 week or more should be treated as separate severe exacerbations.
    • A hospitalisation or ER visit because of asthma, requiring systemic corticosteroids.

    Measured: 1 year & preliminary analysis after 1 month

  3. Moderate asthma exacerbations

    A moderate asthma exacerbation is an event that, when recognized, should result in a temporary change in treatment, in an effort to prevent the exacerbation from becoming severe. Moderate asthma exacerbations are defined by occurrence of at least one or more of the following:

    • deterioration in symptoms,
    • deterioration in lung function,
    • and increased rescue bronchodilator use. These features should last for 2 days or more, but not be severe enough to warrant systemic corticosteroid use and/or hospitalization. ER visits for asthma (e.g., for routine sick care), not requiring systemic corticosteroids, are also classified as moderate exacerbations

    Measured: 1 year & preliminary analysis after 1 month

Secondary outcomes (2)

  1. User acceptence

    User acceptance of each mHealth and home-monitoring system, as determined by user-adherence and the After-Scenario Questionnaire feedback (ASQ)

    Measured: 1 year & preliminary analysis after 1 month

  2. Asthma Control using asthma control questionnaire

    A score of 0.0-0.75 is classified as well-controlled asthma; 0.75-1.5 as a partly controlled; and >1.5 as poorly controlled asthma.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2016 (estimated)
  2. Study startApr 2016
  3. Primary completion31 Jul 2018
  4. Study completion31 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02774772
Sponsor's protocol ID
15/NW/0845
Status last verified
Feb 2019
First submitted
24 Feb 2016
Last updated
7 Feb 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes

Publications

  • Khusial RJ, Sont JK, Usmani OS, Bonini M, Chung KF, Fowler SJ, Honkoop PJ. The Effect of Inhaled Beta-2 Agonists on Heart Rate in Patients With Asthma: Sensor-Based Observational Study. JMIR Cardio. 2024 Dec 11;8:e56848. doi: 10.2196/56848.

    PubMed 39661964

  • Honkoop PJ, Simpson A, Bonini M, Snoeck-Stroband JB, Meah S, Fan Chung K, Usmani OS, Fowler S, Sont JK. MyAirCoach: the use of home-monitoring and mHealth systems to predict deterioration in asthma control and the occurrence of asthma exacerbations; study protocol of an observational study. BMJ Open. 2017 Jan 24;7(1):e013935. doi: 10.1136/bmjopen-2016-013935.

    PubMed 28119390

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Asthma control using the asthma control diary (time frame: After 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02774772, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2019.

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