Mobile Phone Based Structured Intervention
Mobile Phone Based Structured Intervention
Although asthma outcomes can be improved with structured care, less than half of people with
 asthma achieve good control. Part of the problem is poor adherence with self-monitoring and
 preventive drug regimes. This trial will test whether using mobile phone-based monitoring, as
 part of a structured care plan, improves clinical outcomes and confidence in people with
 poorly controlled asthma.

 Adults and teenagers with poorly controlled asthma will be recruited and randomly assigned to
 one of two groups. Those in the mobile phone group will monitor their asthma daily using
 their mobile phone to record symptoms, medication and lung function. Instantaneous feedback
 to their phone will provide a visual indication of asthma control and prompts about therapy.
 The patient and their clinician will have web-based access to all readings. People in the
 control group will use traditional paper-based monitoring. Under the care of their asthma
 nurse, both groups will be treated according to the step-wise approach of the BTS/SIGN asthma
 guideline in order to gain control.

 We will use the validated Asthma Control Questionnaire to measure control at baseline, three
 and six months, and compare improvement in the two groups. We will also assess how confident
 people feel in controlling their asthma, using a validated measure of self-efficacy,
 attitudes and knowledge.

 Technological solutions to long-term healthcare problems are increasingly being sought by
 patients, clinicians and policy makers. If successful, our trial could provide timely
 evidence for the use of information technology to address the long-recognised problem of poor
 asthma control.
A. Hypothesis In teenagers and adults with poorly controlled asthma offered treatment
 according to BTS-SIGN guideline, the use of mobile phone-based lung function and symptom
 monitoring with patient feedback will improve the asthma control achieved and patient
 self-efficacy at six-months compared to usual paper-based monitoring strategies.

 B. Background Despite effective treatments, studies continue to demonstrate that asthma is
 poorly controlled,1,2 though marked variation in the control achieved in UK general practices
 suggests that improvement is possible for the vast majority of patients.3 Psychosocial
 factors such as denial of illness, low outcome expectations 4,5 and hectic lifestyles,
 exacerbated by limited knowledge, poor self-recognition of symptoms and discordant attitudes,
 influence patients' ability to engage in self-management with resultant poor concordance with
 monitoring and treatment.6,7 Interventions involving biofeedback can address these barriers
 by objectively demonstrating symptom severity and the impact of medication compliance.8 A
 Cochrane review demonstrates that self-management education linked with structured care
 improves asthma outcomes.9 Despite self-management education,6 in real life, compliance with
 traditional diary monitoring can be as low as 6%,10 and results are often fabricated.11
 Electronic recording may improve compliance,12 with over two-thirds of potential readings
 recorded over a 72-week trial.13 Increasingly pervasive throughout society, mobile phone
 technology provides a convenient, portable communications medium. Mobile phone-based
 monitoring with supporting biofeedback, appears able to engage patients in their management,
 resulting in high levels of adherence and patient acceptability,13,14 with many patients
 welcoming the innovative care.15,16,17,18 Integrated within a structured care protocol, this
 has the potential to address the barriers of poor adherence and low expectations and thereby
 to improve patient outcomes.

 Monitoring is, in itself, an intervention which alters behaviour. The theoretical model
 developed by Glasziou et al. describes the complementary and evolving roles of periodic
 professional reviews and on-going patient self-monitoring.19 The monitoring of asthma with
 lung function and/or symptoms is cited as a well-defined exemplar of this concept. Our recent
 qualitative study suggests that people with asthma perceive a role for mobile technology in
 aiding transition from clinician-supported phases while control is gained, to effective
 self-management during maintenance phases.20 This approach resonates with two key health
 service policies: the drive for technological solutions to healthcare problems;21 and the
 importance of expert patients and self-management of long-term conditions.22,23 Our proposed
 trial tests the hypothesis that through engaging the patient in self-monitoring with timely
 biofeedback, mobile phone technology can improve the asthma control achieved at six months
 compared to usual paper-based monitoring.

 Our multi-disciplinary team has extensive experience of tele-care, delivery of primary care
 respiratory services, patient self-management, and research within general practice settings.
 Building on extensive background work,3,13-15,17,18,20 we offer expertise in respiratory and
 health services research, and social science and are ideally placed to undertake this trial.

 Description of the mobile phone-based monitoring system (see figure) The system software (T+
 asthma, Oxford, UK) can be loaded onto any web-enabled mobile phone. It permits recording of
 symptoms, medication usage and lung function. Measurements are made with a Piko meter (a
 prescribable electronic meter which records both (FEV1) and peak expiratory flow (PEF)). We
 have opted to record FEV1 because it is a component of the ACQ,24 and the correlation between
 Piko and spirometry FEV1 is excellent (r=0.98).25,26 Data transmitted to a remote server are
 analysed and the latest reading returned to the mobile phone, compared with the preceding
 week's recordings and a prompt for using 'preventer' medication. In addition, the patient and
 their clinician can access the record via a password-protected website.C. Design of the
 research A six month single-blinded randomised controlled trial

 Practice recruitment Six/eight practices (total list 72,000 patients) will be recruited from
 the Leicester area (local to the practice of a lead co-applicant). Eligible practices will
 have an asthma-trained nurse able to commit to the additional clinical workload.

 Participant recruitment Practices will use the Minimal Asthma Assessment Tool (MAAT), which
 interrogates routinely collected data on their computer database, using patterns of
 medication usage, symptom control and biometric data to identify patients (12 years and over)
 with poorly controlled asthma.3 Potential eligibility will be confirmed by inspection of
 manual/computer records checking (and documenting) exclusion criteria: other significant lung
 disease, under specialist care for severe/difficult asthma, unable to communicate in English
 or use a mobile phone and at the request of the GP for other significant social/clinical
 problems. The practice will invite all potentially eligible patients by post to participate.

 Confirmation of eligibility and baseline assessment Potential participants will attend a
 screening assessment (normally in their practice) at which eligibility will be confirmed,
 their current asthma control assessed using the ACQ,24 and suitability of their mobile phone
 established. All patients with poorly controlled asthma (defined as ACQ>1.5 27) will be
 entered in the trial and a baseline assessment undertaken.(see summary table)

 Randomisation Patients will be allocated, using centralised randomisation stratified by
 practice, to mobile phone or paper-based monitoring. The University of Aberdeen's Health
 Services Research Unit will provide a 24hr telephone randomisation service.

 Intervention group: Mobile phone based monitoring Patients in the intervention group will be
 issued with a Piko meter and the T+ software loaded onto their mobile phone. They will be
 asked to monitor symptoms, medication usage and FEV1 twice a day and submit the readings. The
 web-record will be available to patient and asthma nurse to aid assessment of control during
 routine reviews, and to the patients' GP in the event of unscheduled asthma consultations.

 Control group: paper-based monitoring Patients in the control group will be issued with a
 Piko meter, and asked to keep a paper diary, recording symptoms, medication usage and FEV1
 readings twice a day.

 Clinical care and self-management education in both groups Structured care will be provided
 by the practices' asthma nurse(s), trained in all aspects of the trial.

 Clinical care in both groups will be in accordance with the step-wise approach of the
 BTS-SIGN Guideline.28 Patients will be reviewed monthly until control is achieved as judged
 by the nurse on the basis of clinical monitoring.

 All patients will receive a one-to-one standardised asthma education session, including
 information on asthma, asthma treatment, inhaler technique, monitoring and when to seek
 urgent assistance.
Inclusion Criteria:

 -  Patient with poorly controlled asthma

 Exclusion Criteria:

 -  Patient under age of 12

 -  Not possessing a mobile phone and who don't have adequate command of the English
 language