xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05972226</url>
    </required_header>
    <id_info>
      <org_study_id>SCH-2238</org_study_id>
      <nct_id>NCT05972226</nct_id>
    </id_info>
    <brief_title>Self-care, Remote Monitoring and Elearning for Children and Young People With Asthma</brief_title>
    <acronym>ASTHMAME</acronym>
    <official_title>Self-care, Remote Monitoring and Elearning for Children and Young People With Asthma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sheffield Children's NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sheffield Children's NHS Foundation Trust</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Asthma is a long-term condition in children, often managed by general practitioners (GPs) in&#xD;
        primary care but some children with asthma need hospital treatment and care by experienced&#xD;
        paediatricians and nurses. The positive effects of treatment for childhood asthma are&#xD;
        well-documented however, less than 50% children take their medications regularly as&#xD;
        prescribed. As well as causing poor control of asthma symptoms, failing to take medication as&#xD;
        prescribed is a problem that is causing huge cost and wastage to the NHS.&#xD;
  &#xD;
        Some of the barriers to taking medications as prescribed include people's beliefs about their&#xD;
        illness or medications and forgetting or being too busy. These barriers can be addressed by&#xD;
        providing education, reminders and incentives.&#xD;
  &#xD;
        Monitoring medication usage is complex but studies have shown that use of electronic&#xD;
        monitoring devices with education does improve the number of asthma attacks. Digital&#xD;
        solutions for asthma self-care, including &quot;smart-inhalers&quot; that monitor medication usage and&#xD;
        Apps for remote monitoring and self-management are likely to transform health services by&#xD;
        providing supported self-management, prioritisation of the more unwell patients and&#xD;
        reductions in hospital visits.&#xD;
  &#xD;
        Asthma + me, a digital self-care solution has been developed by Aseptika Ltd, in consultation&#xD;
        with Sheffield Children's Hospital, to support children with asthma. It uses a monitoring&#xD;
        device that connects wirelessly to the Asthma +me App and monitors medication usage,&#xD;
        providing education tips, reminders and incentives.&#xD;
  &#xD;
        In this project, 15 children (and their families) will trial Asthma + me with a PUFFClicker&#xD;
        and a 3-4 hour education session and report what worked and what didn't using structured&#xD;
        interviews and questionnaires. At the same time the investigators will map out the number of&#xD;
        patients that could potentially use this solution to self-manage their asthma, with the&#xD;
        support of the hospital, until they are ready to be discharged back to their GP.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Asthma is a long-term condition in children, often managed in primary care but around 20%&#xD;
        children with asthma require secondary or tertiary level treatment and care by experienced&#xD;
        respiratory paediatricians and nurses. The positive effects of treatment with inhaler and&#xD;
        anti-inflammatory medications for childhood asthma are well-documented however, less than 50%&#xD;
        children take their medications regularly as prescribed. Asthma deaths in children are rare&#xD;
        but the national review of asthma deaths in the UK between 2012 and 2013 concluded that two&#xD;
        thirds of the asthma deaths were preventable and that poor adherence to therapy was found to&#xD;
        be a preventable cause in 34%.&#xD;
  &#xD;
        It is known that educational interventions and use of written action plans improve asthma&#xD;
        control. However, two thirds of patients do not attend their asthma review. Lack of adherence&#xD;
        to medications is a global problem with £300million worth of medications /yr wasted in&#xD;
        primary care due to poor adherence and 50% patients not taking medication as prescribed. With&#xD;
        the UK facing an increasingly unmanageable demand on healthcare services, this morbidity and&#xD;
        cost needs to be addressed.&#xD;
  &#xD;
        So, why do people with asthma omit their medications? Clinicians have developed a conceptual&#xD;
        framework to enable clinicians to understand the barriers to medication adherence. Habit&#xD;
        formation is underpinned by a complex interaction of feedback, problem solving, prompts and&#xD;
        implementation plans. The interaction between motivation (reasons that people &quot;won't&quot; take&#xD;
        medication, such as illness perceptions, medication beliefs and contrivance) and capability&#xD;
        opportunity (reasons that people &quot;can't&quot; take medication, such as forgetting, being too busy,&#xD;
        having trouble incorporating into the routine) needs to be understood and addressed in order&#xD;
        to change and sustain habit formation.&#xD;
  &#xD;
        Adherence monitoring methods have been studied at length in patients with asthma, ranging&#xD;
        from non-judgemental questioning by a clinician, which is cheap and easy to do in clinic, but&#xD;
        vastly overestimates adherence, to self-report questionnaires and diary cards to prescription&#xD;
        refill data and drug assays. These methods are increasingly objective, but remain subject to&#xD;
        inaccuracies due to susceptibility to dose &quot;dumping&quot; and impracticalities. The most objective&#xD;
        method of adherence monitoring is the use of electronic monitoring devices (EMDs) which can&#xD;
        provide continuous monitoring and &quot;smart&quot; features such as transmission of data to electronic&#xD;
        devices. The &quot;STAAR&quot; (Study of Asthma Adherence Reminders) study used adherence monitoring&#xD;
        with feedback to target both motivation and capability opportunity with an&#xD;
        educational/behavioural intervention and a practical adherence facilitator with reminder&#xD;
        alarms chosen from a range of alarms by the child. Although a significant improvement in&#xD;
        adherence from 49% to 70% was noted in the intervention group, there was no significant&#xD;
        improvement in ACQ, the primary outcome measure. There was, however, a significantly lower&#xD;
        number of exacerbations in the intervention group, measured by number of hospital and GP&#xD;
        visits, number of courses of oral steroids and number of days missed from school.&#xD;
  &#xD;
        There is a growing number of digital solutions for asthma Self-Care, with many of these&#xD;
        produced by pharmaceutical companies as companion products or research tools. In addition, an&#xD;
        increasing number of HealthApps and remote monitoring self-management software platforms are&#xD;
        appearing on the commercial market. There are challenges to overcome before these can be&#xD;
        implemented in paediatric clinical practice as all are adult based, are of variable quality,&#xD;
        and more research is needed to refine the technology and links to electronic health records.&#xD;
        However, smart inhalers and HealthApps in a digitally evolving NHS have the potential to&#xD;
        support self-management of long-term conditions such as asthma at scale, to support digital&#xD;
        transformation of health services to risk stratify according to need and to provide a&#xD;
        personalised approach to care, thereby reducing emergency admissions and improving patient&#xD;
        safety and quality of life.&#xD;
  &#xD;
        Asthma + me, will be a comprehensive CE-marked technology-enabled self-care solution for&#xD;
        children and young people with asthma and their parents has been developed by Aseptika Ltd,&#xD;
        in consultation with Sheffield Children's Hospital, to support children with asthma to&#xD;
        implement a new intermediate care pathway bridging the transition from hospital outpatient&#xD;
        services back to primary care. It is specifically designed to meet the needs of children aged&#xD;
        5-18yrs and has two versions within the same App; a child-friendly view and a parent/carer&#xD;
        view making it different from the many adult asthma management Apps available. It also&#xD;
        supports integrated devices, medication diaries, trigger alerts and symptom scores. Core to&#xD;
        Asthma +me is education, engagement and empowerment for children /young people and their&#xD;
        parents. It has an in-built syllabus supported with an intensive half-day family training&#xD;
        session to upskill those newly diagnosed.&#xD;
  &#xD;
        Asthma + me supports a universal metered-dose inhaler tracker that connects wirelessly to the&#xD;
        Asthma +me App counting inhaler doses, providing reminders to take the next dose and acting&#xD;
        as an activity tracker for children too young or unable to wear an activity tracker at&#xD;
        school. Patient-generated data will be used to incentivise adherence through a novel&#xD;
        motivating rewards system.&#xD;
  &#xD;
        A PDF report will be sent automatically from Asthma +me to the electronic patient record at&#xD;
        Sheffield Children's Hospital. The consultant paediatrician or asthma nurse can remotely&#xD;
        review progress or can access the patient-generated data in the event of an emergency&#xD;
        consultation. Uniquely, as the child or their parent enters their data, their asthma action&#xD;
        plan is automatically populated, viewed on the smart phone, printed and emailed as an&#xD;
        integral part of the weekly report.&#xD;
  &#xD;
        In this project, 15 children (and their families) will trial Asthma + me with PUFFClicker and&#xD;
        4 hour education session and report what worked and what didn't. The investigators will&#xD;
        assess their views using structured Interviews and questionnaires and the investigators will&#xD;
        look at any changes in their asthma symptoms. The investigators will also map patient&#xD;
        pathways and collect health economics data to project costs and the number of patients that&#xD;
        could potentially use this solution to self-manage their asthma, with the support of the&#xD;
        hospital, until they are ready to be discharged back to their GP.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 16, 2018</start_date>
    <completion_date type="Actual">December 31, 2019</completion_date>
    <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Acceptability</measure>
      <time_frame>17 months</time_frame>
      <description>Acceptability of the Asthma and Me software, the PUFFClicker and the Education package, as assessed by the patient/parent, clinician and teacher using investigator designed questionnaires</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Barriers to implementation of the Asthma and Me software</measure>
      <time_frame>17 months</time_frame>
      <description>Barriers to implementation of the Asthma and Me software, the PUFFClicker and the Education package, as assessed by the patient/parent, clinician and teacher using investigator designed questionnaires</description>
    </primary_outcome>
    <enrollment type="Actual">96</enrollment>
    <condition>Asthma</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 5 to 15 years 11 months&#xD;
  &#xD;
            2. Doctor-diagnosed asthma&#xD;
  &#xD;
            3. Prescribed MDI inhalers&#xD;
  &#xD;
            4. Asthma severity BTS level 3 or below.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 5 to 15 years 11 months&#xD;
  &#xD;
            2. Doctor-diagnosed asthma&#xD;
  &#xD;
            3. Prescribed MDI inhalers&#xD;
  &#xD;
            4. Asthma severity BTS level 3 or below.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Non-English speaking families&#xD;
  &#xD;
            2. Prescribed dry powder inhaler devices&#xD;
  &#xD;
            3. Admission with acute asthma in the last 3 months&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>15 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Clinical Research Facility, Sheffield Childrens Hospital</name>
        <address>
          <city>Sheffield</city>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>December 2019</verification_date>
    <study_first_submitted>December 31, 2019</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Asthma</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05972226
  org study id: SCH-2238
  nct id: NCT05972226
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Asthma is a long-term condition in children, often managed by general practitioners (GPs) in
        primary care but some children with asthma need hospital treatment and care by experienced
        paediatricians and nurses. The positive effects of treatment for childhood asthma are
        well-documented however, less than 50% children take their medications regularly as
        prescribed. As well as causing poor control of asthma symptoms, failing to take medication as
        prescribed is a problem that is causing huge cost and wastage to the NHS.
  
        Some of the barriers to taking medications as prescribed include people's beliefs about their
        illness or medications and forgetting or being too busy. These barriers can be addressed by
        providing education, reminders and incentives.
  
        Monitoring medication usage is complex but studies have shown that use of electronic
        monitoring devices with education does improve the number of asthma attacks. Digital
        solutions for asthma self-care, including "smart-inhalers" that monitor medication usage and
        Apps for remote monitoring and self-management are likely to transform health services by
        providing supported self-management, prioritisation of the more unwell patients and
        reductions in hospital visits.
  
        Asthma + me, a digital self-care solution has been developed by Aseptika Ltd, in consultation
        with Sheffield Children's Hospital, to support children with asthma. It uses a monitoring
        device that connects wirelessly to the Asthma +me App and monitors medication usage,
        providing education tips, reminders and incentives.
  
        In this project, 15 children (and their families) will trial Asthma + me with a PUFFClicker
        and a 3-4 hour education session and report what worked and what didn't using structured
        interviews and questionnaires. At the same time the investigators will map out the number of
        patients that could potentially use this solution to self-manage their asthma, with the
        support of the hospital, until they are ready to be discharged back to their GP.
  Asthma is a long-term condition in children, often managed in primary care but around 20%
        children with asthma require secondary or tertiary level treatment and care by experienced
        respiratory paediatricians and nurses. The positive effects of treatment with inhaler and
        anti-inflammatory medications for childhood asthma are well-documented however, less than 50%
        children take their medications regularly as prescribed. Asthma deaths in children are rare
        but the national review of asthma deaths in the UK between 2012 and 2013 concluded that two
        thirds of the asthma deaths were preventable and that poor adherence to therapy was found to
        be a preventable cause in 34%.
  
        It is known that educational interventions and use of written action plans improve asthma
        control. However, two thirds of patients do not attend their asthma review. Lack of adherence
        to medications is a global problem with £300million worth of medications /yr wasted in
        primary care due to poor adherence and 50% patients not taking medication as prescribed. With
        the UK facing an increasingly unmanageable demand on healthcare services, this morbidity and
        cost needs to be addressed.
  
        So, why do people with asthma omit their medications? Clinicians have developed a conceptual
        framework to enable clinicians to understand the barriers to medication adherence. Habit
        formation is underpinned by a complex interaction of feedback, problem solving, prompts and
        implementation plans. The interaction between motivation (reasons that people "won't" take
        medication, such as illness perceptions, medication beliefs and contrivance) and capability
        opportunity (reasons that people "can't" take medication, such as forgetting, being too busy,
        having trouble incorporating into the routine) needs to be understood and addressed in order
        to change and sustain habit formation.
  
        Adherence monitoring methods have been studied at length in patients with asthma, ranging
        from non-judgemental questioning by a clinician, which is cheap and easy to do in clinic, but
        vastly overestimates adherence, to self-report questionnaires and diary cards to prescription
        refill data and drug assays. These methods are increasingly objective, but remain subject to
        inaccuracies due to susceptibility to dose "dumping" and impracticalities. The most objective
        method of adherence monitoring is the use of electronic monitoring devices (EMDs) which can
        provide continuous monitoring and "smart" features such as transmission of data to electronic
        devices. The "STAAR" (Study of Asthma Adherence Reminders) study used adherence monitoring
        with feedback to target both motivation and capability opportunity with an
        educational/behavioural intervention and a practical adherence facilitator with reminder
        alarms chosen from a range of alarms by the child. Although a significant improvement in
        adherence from 49% to 70% was noted in the intervention group, there was no significant
        improvement in ACQ, the primary outcome measure. There was, however, a significantly lower
        number of exacerbations in the intervention group, measured by number of hospital and GP
        visits, number of courses of oral steroids and number of days missed from school.
  
        There is a growing number of digital solutions for asthma Self-Care, with many of these
        produced by pharmaceutical companies as companion products or research tools. In addition, an
        increasing number of HealthApps and remote monitoring self-management software platforms are
        appearing on the commercial market. There are challenges to overcome before these can be
        implemented in paediatric clinical practice as all are adult based, are of variable quality,
        and more research is needed to refine the technology and links to electronic health records.
        However, smart inhalers and HealthApps in a digitally evolving NHS have the potential to
        support self-management of long-term conditions such as asthma at scale, to support digital
        transformation of health services to risk stratify according to need and to provide a
        personalised approach to care, thereby reducing emergency admissions and improving patient
        safety and quality of life.
  
        Asthma + me, will be a comprehensive CE-marked technology-enabled self-care solution for
        children and young people with asthma and their parents has been developed by Aseptika Ltd,
        in consultation with Sheffield Children's Hospital, to support children with asthma to
        implement a new intermediate care pathway bridging the transition from hospital outpatient
        services back to primary care. It is specifically designed to meet the needs of children aged
        5-18yrs and has two versions within the same App; a child-friendly view and a parent/carer
        view making it different from the many adult asthma management Apps available. It also
        supports integrated devices, medication diaries, trigger alerts and symptom scores. Core to
        Asthma +me is education, engagement and empowerment for children /young people and their
        parents. It has an in-built syllabus supported with an intensive half-day family training
        session to upskill those newly diagnosed.
  
        Asthma + me supports a universal metered-dose inhaler tracker that connects wirelessly to the
        Asthma +me App counting inhaler doses, providing reminders to take the next dose and acting
        as an activity tracker for children too young or unable to wear an activity tracker at
        school. Patient-generated data will be used to incentivise adherence through a novel
        motivating rewards system.
  
        A PDF report will be sent automatically from Asthma +me to the electronic patient record at
        Sheffield Children's Hospital. The consultant paediatrician or asthma nurse can remotely
        review progress or can access the patient-generated data in the event of an emergency
        consultation. Uniquely, as the child or their parent enters their data, their asthma action
        plan is automatically populated, viewed on the smart phone, printed and emailed as an
        integral part of the weekly report.
  
        In this project, 15 children (and their families) will trial Asthma + me with PUFFClicker and
        4 hour education session and report what worked and what didn't. The investigators will
        assess their views using structured Interviews and questionnaires and the investigators will
        look at any changes in their asthma symptoms. The investigators will also map patient
        pathways and collect health economics data to project costs and the number of patients that
        could potentially use this solution to self-manage their asthma, with the support of the
        hospital, until they are ready to be discharged back to their GP.
  observational model: Cohort
  time perspective: Prospective
  measure: Acceptability
  time frame: 17 months
  description: Acceptability of the Asthma and Me software, the PUFFClicker and the Education package, as assessed by the patient/parent, clinician and teacher using investigator designed questionnaires
  measure: Barriers to implementation of the Asthma and Me software
  time frame: 17 months
  description: Barriers to implementation of the Asthma and Me software, the PUFFClicker and the Education package, as assessed by the patient/parent, clinician and teacher using investigator designed questionnaires
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 15 Years
  healthy volunteers: No
  facility: 
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Asthma