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/NCT05979285</url>
    </required_header>
    <id_info>
      <org_study_id>MEDUSA1</org_study_id>
      <nct_id>NCT05979285</nct_id>
    </id_info>
    <brief_title>MEDUSA Study - Migraine: Evaluation of Diagnosis, Utilisation of Services and Application</brief_title>
    <acronym>MEDUSA</acronym>
    <official_title>Evaluation of Patient Experiences of Migraine Management and Feasibility of a Digital Headache Diary in Primary Care Setting: a Prospective Cohort Survey and Evaluative Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cumbria Partnership NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cumbria Partnership 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>
        Migraine is a very common condition characterised by frequent severe headaches that are very&#xD;
        debilitating. Although the frequency and severity does reduce as patient's age, particularly&#xD;
        above the age of 70, in younger and working age people this condition has a significant&#xD;
        impact on people's lives. Patients with migraine are typically diagnosed and managed in&#xD;
        primary care, but can also be treated by neurologists. Recently, NHS England has published&#xD;
        guidance for clinical staff to optimise patient management: reduce admissions to hospital for&#xD;
        migraine and improve the setting in which patients are seen. One recommendation is the&#xD;
        increased use of headache diaries by patients. These may help patients and doctors to improve&#xD;
        migraine diagnosis and its treatment, for example by identifying if there are triggers for&#xD;
        getting a migraine attack. With technological advancements, there are now computer/phone&#xD;
        applications (Apps) that can be used instead of a paper diary. The Curelator N1 Headache App&#xD;
        is one of such migraine specific Apps. In this study, the investigators aim to evaluate if&#xD;
        primary care migraine patients are open to using a digital headache diary App, and how&#xD;
        compliant users of the App will be. The investigators also aim to assess patient feedback on&#xD;
        the use of the N1 Headache App, and if its use aids them in the management of their migraine.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Headaches are one of the most common ailments, and the headache disorder migraine is the&#xD;
        second leading cause of years lived with disability. Some figures for the UK illustrate the&#xD;
        extent of the issue: approximately 10 million people aged 15 - 69 live with migraine , and 3&#xD;
        million workdays are lost every year in to migraine-related absenteeism alone, at a cost of&#xD;
        almost £4.4 billion. In the UK, the annual primary care consultation rate for headache is 4.4&#xD;
        per 100 registered patients, of whom 4% are referred to secondary care for further&#xD;
        assessment. Headache and migraine is the top self-reported chronic condition amongst primary&#xD;
        care patients. Management, including self-management, of migraine appears to be sub-optimal.&#xD;
        Compliance with prophylactic therapy is poor with a limited number of patients using&#xD;
        preventive treatment, even though many do try prophylactic medicines at some stage. After&#xD;
        diagnosis there is often also a delay before preventive treatment is attempted, and commonly&#xD;
        only tried once.&#xD;
  &#xD;
        The issues related to migraine are worsening as reported by NHS England and in the national&#xD;
        media : &quot;NHS England has announced plans aimed at preventing up to 16,500 emergency hospital&#xD;
        admissions for headaches and migraines each year. Greater use of headache diaries, where&#xD;
        patients record their symptoms, and faster access to specialist advice for family doctors are&#xD;
        among the measures intended to reduce the pressure on frontline services.&quot;&#xD;
  &#xD;
        Headache diaries can be paper-based or electronic (Applications or Apps), and prospective or&#xD;
        retrospective. Retrospective diaries are prone to under and overestimation by patients, and&#xD;
        'gaming' - completing e.g. a month worth of data at the end of that month - is a potential&#xD;
        issue with prospective paper-based headache diaries. Electronic diaries may therefore offer a&#xD;
        viable alternative to paper diaries. Numerous migraine diary Apps have been developed in the&#xD;
        last decade, and some of them were found not user-friendly or did not measure clinically&#xD;
        relevant outcomes. A more recent review on the topic of digital headache diaries concluded&#xD;
        that patient and clinically relevant outcome measures for many were Apps were lacking. It is,&#xD;
        however, recognised that headache diaries can aid patients and clinicians to track the course&#xD;
        of a headache disorder, help to identify triggers and inform treatment plans. The usefulness&#xD;
        of health Apps can be measured with a validated Mobile App Rating Scale.&#xD;
  &#xD;
        Study aims and hypothesis&#xD;
  &#xD;
        To assess if a digital headache diary App (Curelator N1 Headache) is an acceptable tool to&#xD;
        monitor migraine in a cohort of primary care patients diagnosed with/coded for migraine by&#xD;
        their GP practice. Furthermore, to determine the compliance rates achieved by users of the N1&#xD;
        Headache App.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 15, 2020</start_date>
    <completion_date type="Actual">December 20, 2021</completion_date>
    <primary_completion_date type="Actual">July 31, 2021</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Prospective cohort study</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>patient interest in N1 Headache App</measure>
      <time_frame>30 days</time_frame>
      <description>percentage of survey responders who indicate they are willing to trial the N1 Headache App</description>
    </primary_outcome>
    <primary_outcome>
      <measure>user compliance for N1 Headache App</measure>
      <time_frame>90 days</time_frame>
      <description>percentage of participants who consent to using the App who comply with daily use in 90 day trial period</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>previous use of digital diary Apps for migraine</measure>
      <time_frame>30 days</time_frame>
      <description>what percentage of responders has previously used a digital diary App for migraine</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>usefulness of N1 Headache App: percentage patients who identify a migraine trigger</measure>
      <time_frame>90 days</time_frame>
      <description>What percentage of patients who use the N1 Headache App often enough do identify a migraine trigger when a report is generated</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health Confidence and digital diary App</measure>
      <time_frame>90 days</time_frame>
      <description>Does use of digital diary App for migraine affect patients' HEalth Confidence Score (Degree of agreeableness with statement 'I know enough about my migraine health', answers being 'disagree', 'neutral', 'agree' and 'strongly agree'</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">887</enrollment>
    <condition>Migraine</condition>
    <condition>Self-Assessment</condition>
    <arm_group>
      <arm_group_label>N1-Headache App</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All participants used the N1-HEadache App, a digital migraine diary that allows identification of triggers/protectors for migraine (as well as monitoring of medication use)</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>N1-Headache App (by Curelator)</intervention_name>
      <description>Digital application allowing patients to monitor their migraines, and to identify triggers and/or protectors for their migraines.</description>
      <arm_group_label>N1-Headache App</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  • Primary care patients diagnosed with or attending their GP practice ('coded for')&#xD;
               migraine in the last 5 years. This may therefore be newly diagnosed patients or&#xD;
               patients with long-standing migraine who attended their GP practice about their&#xD;
               condition.&#xD;
  &#xD;
                 -  Patients aged ≥ 16 years&#xD;
  &#xD;
                 -  Mental capacity to give consent and not using an interpreter for GP consultations&#xD;
                    (ie competent in English and capacity to complete postal survey)&#xD;
  &#xD;
                 -  Part 2 only:&#xD;
  &#xD;
                      -  Completion of complete part 1 survey, including indication that patient&#xD;
                         still has ongoing migraine issues.&#xD;
  &#xD;
                      -  Access to email, internet and Apple or Android technology (ie smartphone,&#xD;
                         tablet or computer)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • Under the age of 16 years&#xD;
  &#xD;
                 -  Unable to fully understand the consent process and provide informed consent due&#xD;
                    to either language barriers or mental capacity&#xD;
  &#xD;
                 -  The patient has concurrent (medical) conditions that in the opinion of the&#xD;
                    investigator may compromise their capacity to complete the survey. Examples would&#xD;
                    be current severe ill health episode.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>120 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Stacey J Fisher, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>substantive employee</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Research &amp; Development Department</name>
        <address>
          <city>Carlisle</city>
          <state>Cumbria</state>
          <zip>CA1 3SX</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <results_reference>
      <citation>Jonker L, Fitzgerald L, Vanderpol J, Fisher S. Digital diary App use for migraine in primary care: Prospective cohort study. Clin Neurol Neurosurg. 2022 Mar 25;216:107225. doi: 10.1016/j.clineuro.2022.107225. Online ahead of print.</citation>
      <PMID>35364371</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 14, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>migraine</keyword>
    <keyword>patient diary</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Migraine Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05979285
  org study id: MEDUSA1
  nct id: NCT05979285
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Migraine is a very common condition characterised by frequent severe headaches that are very
        debilitating. Although the frequency and severity does reduce as patient's age, particularly
        above the age of 70, in younger and working age people this condition has a significant
        impact on people's lives. Patients with migraine are typically diagnosed and managed in
        primary care, but can also be treated by neurologists. Recently, NHS England has published
        guidance for clinical staff to optimise patient management: reduce admissions to hospital for
        migraine and improve the setting in which patients are seen. One recommendation is the
        increased use of headache diaries by patients. These may help patients and doctors to improve
        migraine diagnosis and its treatment, for example by identifying if there are triggers for
        getting a migraine attack. With technological advancements, there are now computer/phone
        applications (Apps) that can be used instead of a paper diary. The Curelator N1 Headache App
        is one of such migraine specific Apps. In this study, the investigators aim to evaluate if
        primary care migraine patients are open to using a digital headache diary App, and how
        compliant users of the App will be. The investigators also aim to assess patient feedback on
        the use of the N1 Headache App, and if its use aids them in the management of their migraine.
  Headaches are one of the most common ailments, and the headache disorder migraine is the
        second leading cause of years lived with disability. Some figures for the UK illustrate the
        extent of the issue: approximately 10 million people aged 15 - 69 live with migraine , and 3
        million workdays are lost every year in to migraine-related absenteeism alone, at a cost of
        almost £4.4 billion. In the UK, the annual primary care consultation rate for headache is 4.4
        per 100 registered patients, of whom 4% are referred to secondary care for further
        assessment. Headache and migraine is the top self-reported chronic condition amongst primary
        care patients. Management, including self-management, of migraine appears to be sub-optimal.
        Compliance with prophylactic therapy is poor with a limited number of patients using
        preventive treatment, even though many do try prophylactic medicines at some stage. After
        diagnosis there is often also a delay before preventive treatment is attempted, and commonly
        only tried once.
  
        The issues related to migraine are worsening as reported by NHS England and in the national
        media : "NHS England has announced plans aimed at preventing up to 16,500 emergency hospital
        admissions for headaches and migraines each year. Greater use of headache diaries, where
        patients record their symptoms, and faster access to specialist advice for family doctors are
        among the measures intended to reduce the pressure on frontline services."
  
        Headache diaries can be paper-based or electronic (Applications or Apps), and prospective or
        retrospective. Retrospective diaries are prone to under and overestimation by patients, and
        'gaming' - completing e.g. a month worth of data at the end of that month - is a potential
        issue with prospective paper-based headache diaries. Electronic diaries may therefore offer a
        viable alternative to paper diaries. Numerous migraine diary Apps have been developed in the
        last decade, and some of them were found not user-friendly or did not measure clinically
        relevant outcomes. A more recent review on the topic of digital headache diaries concluded
        that patient and clinically relevant outcome measures for many were Apps were lacking. It is,
        however, recognised that headache diaries can aid patients and clinicians to track the course
        of a headache disorder, help to identify triggers and inform treatment plans. The usefulness
        of health Apps can be measured with a validated Mobile App Rating Scale.
  
        Study aims and hypothesis
  
        To assess if a digital headache diary App (Curelator N1 Headache) is an acceptable tool to
        monitor migraine in a cohort of primary care patients diagnosed with/coded for migraine by
        their GP practice. Furthermore, to determine the compliance rates achieved by users of the N1
        Headache App.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Prospective cohort study
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: patient interest in N1 Headache App
  time frame: 30 days
  description: percentage of survey responders who indicate they are willing to trial the N1 Headache App
  measure: user compliance for N1 Headache App
  time frame: 90 days
  description: percentage of participants who consent to using the App who comply with daily use in 90 day trial period
  measure: previous use of digital diary Apps for migraine
  time frame: 30 days
  description: what percentage of responders has previously used a digital diary App for migraine
  measure: usefulness of N1 Headache App: percentage patients who identify a migraine trigger
  time frame: 90 days
  description: What percentage of patients who use the N1 Headache App often enough do identify a migraine trigger when a report is generated
  measure: Health Confidence and digital diary App
  time frame: 90 days
  description: Does use of digital diary App for migraine affect patients' HEalth Confidence Score (Degree of agreeableness with statement 'I know enough about my migraine health', answers being 'disagree', 'neutral', 'agree' and 'strongly agree'
  arm group label: N1-Headache App
  arm group type: Experimental
  description: All participants used the N1-HEadache App, a digital migraine diary that allows identification of triggers/protectors for migraine (as well as monitoring of medication use)
  intervention type: Device
  intervention name: N1-Headache App (by Curelator)
  description: Digital application allowing patients to monitor their migraines, and to identify triggers and/or protectors for their migraines.
  arm group label: N1-Headache App
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: 120 Years
  healthy volunteers: No
  last name: Stacey J Fisher, MD
  role: Principal Investigator
  affiliation: substantive employee
  facility: 
  country: United Kingdom
  citation: Jonker L, Fitzgerald L, Vanderpol J, Fisher S. Digital diary App use for migraine in primary care: Prospective cohort study. Clin Neurol Neurosurg. 2022 Mar 25;216:107225. doi: 10.1016/j.clineuro.2022.107225. Online ahead of print.
  PMID: 35364371
  responsible party type: Sponsor
  mesh term: Migraine Disorders
  sharing ipd: No