<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/NCT01675921</url>
  </required_header>
  <id_info>
    <org_study_id>2012-P-000674/1</org_study_id>
    <nct_id>NCT01675921</nct_id>
  </id_info>
  <brief_title>Implementation of ACT Through Facebook for Teenagers With Asthma</brief_title>
  <acronym>C2MA</acronym>
  <official_title>Implementation of ACT Through Facebook for Teenagers With Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesize that at the end of the 12-month trial, teenagers regularly&#xD;
      self-monitoring their asthma control with ACT administered through Facebook will have&#xD;
      improved ACT scores as compared with teenagers receiving usual care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators propose to administer the Asthma Control Test (ACT), a clinically validated&#xD;
      and reliable measure of asthma control, to a pediatric pulmonary patient population, using&#xD;
      novel channels to improve usage of the tool and health outcomes. The investigators will&#xD;
      administer ACT to patients using Facebook to monitor asthma control and notify clinicians&#xD;
      when there is deterioration of control.&#xD;
&#xD;
      The goal is to improve health outcomes in patients with asthma by measuring adherence to the&#xD;
      use of monitoring tool, follow-up visits to their specialist, and hospitalization/Emergency&#xD;
      Department (ED) visits. To achieve this, the investigators will use a novel technology&#xD;
      platform that is simple, secure, private and easily scalable to other relevant sites and&#xD;
      groups, without the need for additional investment. Currently, patients take the ACT survey&#xD;
      only during their scheduled office appointments. The aim of the study is to increase the use&#xD;
      of ACT to monitor patients who see a pediatric pulmonologist to promote regular&#xD;
      self-monitoring.&#xD;
&#xD;
      ACT is a short symptom-based survey consisting of 5 questions, validated in English and&#xD;
      Spanish. Participants will receive reminders on Facebook every month to login to the study&#xD;
      website to complete the ACT survey therefore allowing patients to easily take the survey on a&#xD;
      regular basis, and receive reminders and educational content in the media spaces they already&#xD;
      inhabit. Participants would receive reminders and links in the same way they would receive&#xD;
      other reminders or notifications from Facebook. The system will rate asthma control and send&#xD;
      patients and their specialist notification of status if it reaches critical levels, defined&#xD;
      as a score of 14 or lower on the ACT survey. This will be a system generated notification,&#xD;
      based on a protocol developed in conjunction with the physicians at the Massachusetts General&#xD;
      Hospital (MGH) pediatric pulmonary department.&#xD;
&#xD;
      The intervention will study the efficacy of electronic social networks in engaging teenagers&#xD;
      in their asthma control over time, using a simple but effective symptom-based survey tool.&#xD;
      Both patients and providers would receive notifications in case of deteriorating control,&#xD;
      which could result in early intervention and lead to better clinical outcomes by prompting&#xD;
      timely intervention by the clinician. The Center for Connected Health (CCH) will work with&#xD;
      the MGH Department of Pulmonology, as well as the Pediatric Asthma group at Partners&#xD;
      Community HealthCare Inc. (PCHI) to enroll ambulatory teenagers with asthma in the research&#xD;
      study for one year.&#xD;
&#xD;
      120 participants will be enrolled and randomly assigned to one of two groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Asthma Control Test (ACT) scores</measure>
    <time_frame>0 to 12 months</time_frame>
    <description>Assess the effect of the Facebook intervention (also referred to as &quot;Connect 2 My ACT&quot; intervention on trends of ACT scores in teenagers diagnosed with asthma</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Emergency Department (ED) visits and Hospital Admissions</measure>
    <time_frame>0 to 12 months</time_frame>
    <description>Compare frequency of ED and hospital admissions between the intervention and control groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Engagement</measure>
    <time_frame>0 to 12 months</time_frame>
    <description>To assess participant engagement in the program (total number of times ACT survey taken divided by 12)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Provider engagement</measure>
    <time_frame>0 to 12 months</time_frame>
    <description>To assess provider engagement in the program (# of times reached out to patient when alerted)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient engagement and Emergency Department (ED) visits</measure>
    <time_frame>0 to12 months</time_frame>
    <description>To correlate participant engagement with change in ED visits and hospital admissions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with intervention</measure>
    <time_frame>at 12 months</time_frame>
    <description>To assess usability and satisfaction with the Facebook study group by administering a survey at completion of study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in knowledge about asthma</measure>
    <time_frame>0 to12 months</time_frame>
    <description>To assess changes in level of knowledge about asthma using the Asthma Self-Management Questionnaire, a standardized and validated survey instrument</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will continue to receive medical care from their doctor as usual.&#xD;
Participants will have access to this study website at the start and at the end of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Facebook group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will continue to receive medical care from their doctor as usual.&#xD;
Participants will have access to the study website at all times throughout the study.&#xD;
Participants will have access to the secret study group on Facebook for 12 months.&#xD;
Participants will take the ACT survey once a month for 12 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Facebook group</intervention_name>
    <description>Facebook will be used to remind participants to take the ACT survey once every month for 12 months.</description>
    <arm_group_label>Facebook group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Teenagers age 14-17 years inclusive.&#xD;
&#xD;
          -  Diagnosis of asthma by a PCP or a specialist at a Partners affiliated hospital/health&#xD;
             center.&#xD;
&#xD;
          -  Access to computer with internet.&#xD;
&#xD;
          -  Active email account&#xD;
&#xD;
          -  Fluency in English (spoken and written)&#xD;
&#xD;
          -  Be on controller medications (such as: inhaled corticosteroids, cromolyn sodium and&#xD;
             nedocromil sodium, long-acting beta-agonists (LABAs), and methylxanthines) to control&#xD;
             asthma and prevent symptoms from developing.&#xD;
&#xD;
          -  Have an active account on Facebook&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Disability or co-morbidity precluding regular access to the internet.&#xD;
&#xD;
          -  Cognitive impairment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kamal Jethwani, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Partners Healthcare, Center for Connected Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Partners Center for Connected Health</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>August 29, 2020</last_update_submitted>
  <last_update_submitted_qc>August 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Joseph C. Kvedar</investigator_full_name>
    <investigator_title>Dermatologist</investigator_title>
  </responsible_party>
  <keyword>Asthma</keyword>
  <keyword>Facebook</keyword>
  <keyword>teenagers</keyword>
  <keyword>ACT</keyword>
  <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>


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/NCT01675921
org study id: 2012-P-000674/1
nct id: NCT01675921
lead sponsor: 
has dmc: No
The investigators hypothesize that at the end of the 12-month trial, teenagers regularly
      self-monitoring their asthma control with ACT administered through Facebook will have
      improved ACT scores as compared with teenagers receiving usual care.
The investigators propose to administer the Asthma Control Test (ACT), a clinically validated
      and reliable measure of asthma control, to a pediatric pulmonary patient population, using
      novel channels to improve usage of the tool and health outcomes. The investigators will
      administer ACT to patients using Facebook to monitor asthma control and notify clinicians
      when there is deterioration of control.

      The goal is to improve health outcomes in patients with asthma by measuring adherence to the
      use of monitoring tool, follow-up visits to their specialist, and hospitalization/Emergency
      Department (ED) visits. To achieve this, the investigators will use a novel technology
      platform that is simple, secure, private and easily scalable to other relevant sites and
      groups, without the need for additional investment. Currently, patients take the ACT survey
      only during their scheduled office appointments. The aim of the study is to increase the use
      of ACT to monitor patients who see a pediatric pulmonologist to promote regular
      self-monitoring.

      ACT is a short symptom-based survey consisting of 5 questions, validated in English and
      Spanish. Participants will receive reminders on Facebook every month to login to the study
      website to complete the ACT survey therefore allowing patients to easily take the survey on a
      regular basis, and receive reminders and educational content in the media spaces they already
      inhabit. Participants would receive reminders and links in the same way they would receive
      other reminders or notifications from Facebook. The system will rate asthma control and send
      patients and their specialist notification of status if it reaches critical levels, defined
      as a score of 14 or lower on the ACT survey. This will be a system generated notification,
      based on a protocol developed in conjunction with the physicians at the Massachusetts General
      Hospital (MGH) pediatric pulmonary department.

      The intervention will study the efficacy of electronic social networks in engaging teenagers
      in their asthma control over time, using a simple but effective symptom-based survey tool.
      Both patients and providers would receive notifications in case of deteriorating control,
      which could result in early intervention and lead to better clinical outcomes by prompting
      timely intervention by the clinician. The Center for Connected Health (CCH) will work with
      the MGH Department of Pulmonology, as well as the Pediatric Asthma group at Partners
      Community HealthCare Inc. (PCHI) to enroll ambulatory teenagers with asthma in the research
      study for one year.

      120 participants will be enrolled and randomly assigned to one of two groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Asthma Control Test (ACT) scores
time frame: 0 to 12 months
description: Assess the effect of the Facebook intervention (also referred to as "Connect 2 My ACT" intervention on trends of ACT scores in teenagers diagnosed with asthma
measure: Emergency Department (ED) visits and Hospital Admissions
time frame: 0 to 12 months
description: Compare frequency of ED and hospital admissions between the intervention and control groups
measure: Engagement
time frame: 0 to 12 months
description: To assess participant engagement in the program (total number of times ACT survey taken divided by 12)
measure: Provider engagement
time frame: 0 to 12 months
description: To assess provider engagement in the program (# of times reached out to patient when alerted)
measure: Patient engagement and Emergency Department (ED) visits
time frame: 0 to12 months
description: To correlate participant engagement with change in ED visits and hospital admissions.
measure: Satisfaction with intervention
time frame: at 12 months
description: To assess usability and satisfaction with the Facebook study group by administering a survey at completion of study
measure: Change in knowledge about asthma
time frame: 0 to12 months
description: To assess changes in level of knowledge about asthma using the Asthma Self-Management Questionnaire, a standardized and validated survey instrument
arm group label: Control
arm group type: No Intervention
description: Participants will continue to receive medical care from their doctor as usual.
Participants will have access to this study website at the start and at the end of the study.
arm group label: Facebook group
arm group type: Experimental
description: Participants will continue to receive medical care from their doctor as usual.
Participants will have access to the study website at all times throughout the study.
Participants will have access to the secret study group on Facebook for 12 months.
Participants will take the ACT survey once a month for 12 months.
intervention type: Other
intervention name: Facebook group
description: Facebook will be used to remind participants to take the ACT survey once every month for 12 months.
arm group label: Facebook group
criteria: 
gender: All
minimum age: 14 Years
maximum age: 17 Years
healthy volunteers: No
last name: Kamal Jethwani, MD, MPH
role: Principal Investigator
affiliation: Partners Healthcare, Center for Connected Health
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Joseph C. Kvedar
investigator title: Dermatologist
mesh term: Asthma