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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02774772
• Other study ID #: 15/NW/0845
• Status: Completed
• Start date: April 2016
• Est. completion date: July 31, 2018

Study information

• Verified date: February 2019
• Source: Manchester University NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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 (0.751.5)].

• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Doctors-diagnosis of asthma with confirmation of asthma from one or more of the following tests in medical notes:

i) 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

2. BTS asthma treatment step 2-4, for a minimum of 6 months in the previous year

3. 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)

Exclusion Criteria:

1. 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.).

2. Unable to understand English or Dutch, as appropriate

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United Kingdom	University Hospital of South Manchester	Manchester

Sponsors (4)

Lead Sponsor	Collaborator
Manchester University NHS Foundation Trust	Imperial College London, Leiden University Medical Center, University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	After 1 month
Primary	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.	1 year & preliminary analysis after 1 month
Primary	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	1 year & preliminary analysis after 1 month
Secondary	User acceptence	User acceptance of each mHealth and home-monitoring system, as determined by user-adherence and the After-Scenario Questionnaire feedback (ASQ)	1 year & preliminary analysis after 1 month
Secondary	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.	1 year