Evaluation of a Mobile Direct Observation Therapy (DOT) Approach in Children and Young People With Asthma
Condition: Asthma in Children
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Mobilte Direct Observation Therapy (MDOT) is a technology has the potential to be a cost
      effective approach to direct observation of therapy administration, the latter being one of
      the most accurate methods of evaluating adherence. Use to date, as confirmed by the rapid
      systematic review, has been limited mainly to TB and sickle cell disease and there have been
      no published reports on the use of MDOT to monitor inhaled therapy. Due to the increasing
      incidence of childhood asthma worldwide, there is a need for new innovative approaches to
      support children and their parents with asthma management, especially since national and
      international guidelines have advised healthcare providers to periodically assess inhaler use
      as part of asthma management.
    

Detailed description: 
      Asthma is the most common chronic disease in childhood. It is defined as a chronic
      inflammatory disorder of the airways in which many cells and cellular elements promote airway
      obstruction and hyper-responsiveness (GINA, 2012). According to the World Health Organization
      (WHO, 2014), asthma is estimated to affect approximately 253 million people worldwide.
      Despite advances in biological and pathological research, the prevalence of asthma in
      children has significantly increased over the past decade (Massingham et al., 2014).

      Moreover, the economic burden of asthma is increasing. In the US, it is estimated that the
      yearly cost of asthma in children and adults is around $1.48 billion (Price et al., 2013). A
      decade ago, the total annual asthma expenditure in the UK was determined to be £752.6 million
      with 8% of costs associated with hospital admission, 13% attributable to general practitioner
      consultations and 79% due to prescription costs (Gupta et al., 2004).

      The British Thoracic Society (BTS/SIGN, 2012) and Global Initiative for Asthma (GINA, 2012)
      guidelines provide the background definitions for three broad categories of asthma control.
      They include controlled (no nocturnal wakening, infrequent short acting beta 2 agonist (SABA)
      use e.g. < 2 puffs/week, occasional mild symptoms e.g. with exercise and no exacerbations in
      last 3 months), partially controlled (nocturnal wakening < 3 nights/week, SABA use e.g. < 4
      puffs/day, mild limitation in exercise tolerance due to asthma, and 2 or fewer mild
      exacerbations in the previous 3 months) or uncontrolled (nocturnal wakening 4-7 nights/week,
      SABA use e.g. > 5 puffs/day, limitation in exercise tolerance due to asthma and or
      significant asthma exacerbations requiring oral steroid, Emergency Department attendance or
      hospital admission in the previous 3 months). Children who present with partially controlled
      or uncontrolled asthma can be divided into difficult to treat asthma (DTA) and true severe
      therapy resistant asthma (STRA) after careful investigation (Hedlin et al., 2012). DTA occurs
      when asthma is uncontrolled but the impact of concomitant disorders and the basics of asthma
      care (inhaler technique and adherence) have not been adequately resolved.

      Many children with asthma can achieve symptom and disease control by using inhaled
      corticosteroid (ICS) therapy combined with a long acting B2 agonist (LABA) and/or a
      leukotriene receptor antagonist (LTRA) (International ERS/ATS guideline, 2014). However, a
      number of children with asthma experience frequent symptoms despite being prescribed high
      dose ICS (Nagakumar and Thomas, 2013; Hedlin et al., 2014).

      Drug delivery by inhalation of various medications is the most common treatment approach for
      asthma in all patient populations. Inhalation therapy offers rapid onset and improved
      efficacy compared to systemic drug delivery (Bisgaard, 1997). While ICS therapy is well
      accepted as the foundation of optimal therapy for most asthma patients, efficacy of the
      therapy depends on drug being delivered correctly into the lungs and taken on a regular basis
      as a preventer therapy (Machira et al., 2011).

      It has been suggested that good inhaler technique is an essential aspect of optimal asthma
      management. Education on inhaler technique has been shown to improve self- management and
      adherence to asthma therapy. Evidence is available demonstrating that asthma outcomes
      correlate with proper inhaler technique and that periodically assessing this treatment aspect
      has a positive impact on asthma control (Bryant et al., 2013; AL-Jahdali et al., 2013).
      Moreover, early and repeated tailored education and follow-up assessment can result in
      sustained good inhaler technique (Klot et al., 2011). However, many asthma clinics treating
      children are unable to effectively evaluate these important patient treatment variables.

      Adherence to pharmacotherapy is also considered an important basic tenet of asthma
      management. Adherence can simply be defined as the extent to which a patient follows the
      instructions of the prescriber (Osterberg and Blaschke, 2005). While inhaled therapy
      technique is an essential feature of asthma pharmacotherapy, some patients with good
      technique may have poor inhaler adherence. Available data suggest the average medication
      adherence to ICS in children is only approximately 50% (Fish et al., 2001; Osterberg and
      Blaschke, 2005).

      It is known that adherence to ICS in children is a complicated matter influenced by diverse
      issues including socioeconomic factors, parents' beliefs about asthma and asthma medications,
      and poor patient-doctor communication (Osterberg and Blaschke, 2005; Armstrong et al., 2014).
      In addition, parent/guardian health issues such as depression or substance abuse may
      negatively affect adherence in young children as a result of the parent/guardian's failure to
      remind, or assist the child in the use of their medication (Brackis-Cott et al., 2003).
      Non-adherence to medication can have various negative patient consequences such as more
      frequent clinic visits, disease exacerbations, hospital admissions, and increased cost of
      care (AL-Jahdali et al., 2013). Indeed, a recent review of childhood asthma deaths in SE
      England showed that medication non-adherence was a contributing factor in more than 50% of
      cases, including patients with milder disease (Anagnostou et al.,2012) Despite being an area
      of active research, many interventions such as isolated educational efforts are ineffective
      in improving adherence (Drotar and Bonner, 2009). In a qualitative study in the primary care
      setting, asthmatic children of parents who expressed medication beliefs of a high concern-low
      need pattern had poor outcomes. Researchers subsequently showed that these beliefs could be
      modified by repeated tailored education and close follow-up, to result in high medication
      adherence. They concluded that "it is not the education per se, but rather the intensity,
      quality and frequency of education about self-management and follow-up that help to improve
      adherence" (Klot et al., 2011). A multicentre clinical trial in the USA was designed to
      determine what medication was best to add in children with severe asthma already taking ICS
      and LABA. However,the trial was cut short due to an inability to recruit an adequate number
      of children. Patient improvement while under close supervision during the run in period was
      the main reason for the lack of patient recruitment. (Strunk et al., 2008) Different methods
      used to assess patient adherence to prescribed therapy have resulted in variable outcomes.
      Adherence can be measured by collecting data from patients or their parent/guardians,
      pharmacy dispensing records, electronic monitoring devices, or patient observation (Osterberg
      and Blaschke, 2005). Since the approaches have produced variable results, it can be concluded
      that presently there is no preferred method to effectively measure or improve medication
      adherence in asthma (Sumino and Cabana, 2013).

      Direct observation therapy (DOT) is recommended by the WHO to promote adherence in the
      management of tuberculosis (TB) and this approach was adopted in 187 countries by 2005 (WHO,
      2010). DOT allows assessment of correctly taking and completing therapy, but also can be
      valuable to promote adherence to medication use. DOT involves a healthcare professional
      observing patients taking their medication at home or in the clinic (Dosumu, 2001; Otu,
      2013). The DOT approach to TB management has been utilised successfully in different
      countries as this approach has been shown to enhance medication adherence, improve outcomes
      including microbiologic success, and decrease acquired drug resistance to therapy (Favorov et
      al., 2012; Walley et al., 2001; Pasipanodya and Gumbo, 2013).

      While data exist to show that observation of inhaler technique can positively affect asthma
      management, there are no published studies using a DOT approach as a means to improve
      medication adherence. However, it has been suggested that using DOT with nurses directly
      observing asthmatic children's inhaler technique and adherence, for example at school or
      home, would be very resource intensive and likely not feasible for continued use (Otu, 2013).

      In recent years, there has been widespread use of mobile smartphone and computer devices
      within the healthcare environment. A recent survey of teenagers and caregivers in urban
      paediatric practices showed that 84% of respondents were smartphone owners, a finding that
      was independent of age group, gender, ethnicity, and socioeconomic status (Singh et al.,
      2014). DeMaio et al. (2001) conducted a pilot study that compared videophone telemedicine
      (V-DOT) to standard DOT (S-DOT) in the treatment of TB. In the videophone group, patients
      took videos of medication administration that were provided to clinicians involved in their
      management. The adherence rate was 95% for V-DOT compared to 97.5 % for S-DOT, but personnel
      time was decreased by 288 hours with V-DOT in only 6 patients. Similarly, a telehealth
      videophone home monitoring approach to TB was shown to enhance treatment compliance and use
      less clinic resources in a larger study by Wade et al. (2012).

      More recently, Creary et al. (2014) developed a novel mobile DOT approach utilising
      smartphone and computer devices that resulted in a median monthly observed adherence of 93.3%
      over the 6 month trial in children with sickle cell disease. Finally, specific to asthma
      patients, Vasbinder et al., (2013) has developed a study to access the effectiveness of using
      mobile phone text-messages to remind and encourage non-adherent patients to take their
      medication and thereby improve control of their disease; results of the study are not yet
      available. Limited available evidence, therefore, suggests that communication technology
      could be utilised to achieve therapeutic goals of correct administration technique and
      improved adherence to therapy in asthma patients while limiting resource utilisation.

      The principal aim of this study is to evaluate the feasibility and clinical impact of a
      mobile DOT approach (via video capture in the patient's home) on the administration technique
      for, and adherence to, ICS in children with partially controlled or uncontrolled asthma. A
      secondary aim is to determine factors that influence adherence to ICS in children with
      asthma.

      The specific objectives are to:

        1. Investigate the feasibility, practicality, and persistence of a mobile DOT technology
           approach in the home setting to assist with disease management of children and young
           people with partially controlled or uncontrolled asthma.

        2. Assess inhaler technique and adherence to ICS therapy by use of DOT videos,
           parent/guardian and child self-report questionnaires (Medication Adherence Report Scale
           (MARS)), pharmacy records and patient's general practitioner (GP) records.

        3. Evaluate the impact of the DOT intervention on asthma clinical outcomes including
           physician assessment of disease control, medication changes, asthma control tests,
           health-related quality of life and pulmonary function studies in participating children.

        4. Identify parental/guardian and patient factors that influence adherence to ICS in
           participating children and young people with asthma
    

Intervention name(s): Mobile Direct Observation of Therapy (MDOT)
Intervention type(s): Device
Intervention description(s): Patients who are enrolled in the study will be randomised into two groups (I-med or D-med) to receive Mobile Direct Observation of Therapy (MDOT). Participants or parents/guardians of participants will be asked to capture a DOT video twice daily (morning and evening) on their mobile devices of ICS use by the patient. In the I-med group, participants will be asked to upload daily video recordings via the internet to a repository for a 6 week period at the start of the study. Participants in the D-med group will be free from DOT for the first 6 weeks of the study and will be asked to carry out their usual therapy management. After that, DOT as described above will be applied for the next 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomised intervention trial will be used. Participants will be randomised to either an immediate (I-med) or a delayed (D-med) intervention. Randomisation will be restricted based on two factors including age and patient gender.
Both subject groups will receive standard-of-practice asthma education and management in the Asthma Clinic prior to study enrolment. Participants allocated to the I-med group will take part in the mobile technology DOT intervention for the first 6 weeks. Outcomes will be evaluated at the start (week 0) and end of the 6 week intervention period and during clinic visits at weeks 12 and 18 for follow-up. Those participants allocated to the D-med group will have the DOT intervention started after a 6 week "intervention-free" interval with usual Asthma Clinic care.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Inhaler assessment; Direct observation of therapy