Digital Action Plan for Asthma Attacks
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      It is recommended that patients with asthma owned a written action plan which must include
      the names, doses and dosing of the treatment they should take when acute respiratory symptoms
      occur.

      Current written action plans must be short to be readily used (1 page) and, therefore, cannot
      fit all acute situations. Moreover, they may not be available where and when required.

      The investigators sought that a digital action plan, available through Smartphone or tablet
      computer connected to the internet, could adequately provide suitable action plans according
      to the severity of the described exacerbation, and would be more easily available when
      useful.

      The aim of the study is to study the effect of the use of a digital action plan for asthma
      exacerbation, on the frequency of unscheduled medical contacts (phone calls, visits to
      physicians or to emergency departments, hospitalizations) in children and in adults with
      asthma. The investigators hypothesized that the use of the digital action plan could reduce
      avoidable unscheduled visits due to mild or moderate exacerbations that could successfully be
      managed by the patient or his/her caregivers.
    

Detailed description: 
      Asthma is a frequent chronic disease (10% prevalence in children and 7% in adults) during
      which acute exacerbations can occur that require adequate treatment, usually by the patients
      and/or his/her caregivers. Despite action plan for asthma exacerbation being recommended by
      national and international guidelines, urgent medical contact and often Emergency Department
      visits remain frequent for asthma exacerbation.

      Reasons for medical contact may be related to the inefficiency of the current Written Action
      Plan because of its stereotyped advice whatever the level of severity of the exacerbation,
      and because the patients might not have the paper with him/her where and when he/she needs
      it.

      The investigators sought that new electronic technologies could solve these issues of
      inadequacy of content and availability of the Written Action Plan.

      A program was built to provide sets of advices according to the severity of the exacerbation
      described by the patient using simple clinical descriptors included in the Global Initiative
      for Asthma (GINA), and weighted by the medication already used for the exacerbation. In this
      way the investigators feel that patients could be more confident in the appropriate treatment
      proposed by the algorithm. Second, the possibility to connect through portable electronic
      devices (Smartphone, tablet computer) make the action readily available as far as an internet
      connection is possible.

      The Digital Action Plan is designed to treat asthma exacerbations of all levels of severity
      and advice to visit a doctor within few days or to go at once to an emergency department as
      appropriate as by the situation based on the patients' information. The investigators
      designed a randomized study to assess the effect of the Digital Action Plan on unscheduled
      urgent medical contacts (phone calls, visits to physicians or to emergency departments,
      hospitalizations) in children and in adults with asthma.

      Methodology of the study A multicenter, controlled, randomized, open study, comparative on 2
      parallel groups recruited in private practice and in hospitals within or outside the APHP
      consortium.

      Both arms have the Written Action Plan respecting the current recommendations; the
      experimental arm has in addition the possibility to connect to the AppWeb to obtain advices
      from the Digital Action Plan.

      The investigators hypothesized that the use of the digital action plan could reduce avoidable
      unscheduled visits due to mild or moderate exacerbations that could successfully be managed
      by the patient or his/her caregivers. In the long run, this kind of program could also become
      a tool for telemedicine Statistical analysis : about 80% of children and adult patients
      included will have a exacerbation during the follow-up year. The expected effect of the
      Digital Action Plan is a 20% (relative variation) decrease of the main outcome : in Written
      Action Plan group, frequency = 0.8, in Digital Action Plan group, frequency = 0.64 (20% i.e.
      0.16 reduction of frequency). Moreover, the Written Action Plan has been shown to result in a
      25% decrease of unscheduled visits for severe exacerbation (4); we therefore hypothesize that
      the supplemental reduction in unscheduled visits induced by the Digital Action Plan will be
      smaller than that of Written Action Plan despite the recording of moderate exacerbations in
      addition to severe exacerbations. . With this features, samples of N= 121 per group are
      necessary (80% power, bilateral alpha risk of 5%). With an expected attrition of about 15%, a
      total of 280 patients will be included. This target can be achieved with regard to the
      activity of participating centers.

      Number of participating centers = 43
    

Intervention name(s): Digital action plan for asthma exacerbations + Written action plan; Written action plan
Intervention type(s): Other; Other
Intervention description(s): Digital action plan for asthma exacerbation available through an AppWeb and requiring a connected device such as a Smartphone or a tablet computer. The patient must connect and describe the situation to obtain the names, doses and dosing of the treatment his/her physician has recommended for him/her according to the level of severity of the exacerbation
Other intervention name(s): Digital action plan for asthma exacerbations
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Asthma; Exacerbation; Treatment; Internet; Emergency care