<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/NCT03800082</url>
  </required_header>
  <id_info>
    <org_study_id>389044</org_study_id>
    <nct_id>NCT03800082</nct_id>
  </id_info>
  <brief_title>Development and Usability Testing of a Progressive WebApp for Women With Heart Disease</brief_title>
  <acronym>at heart</acronym>
  <official_title>Development and Usability Testing of a Progressive WebApp for Women With Heart Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Toronto</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>
      The overall goal of this program of research is to develop and systematically evaluate an&#xD;
      integrated smartphone and web-based intervention (at heart [formerly called HEARTPA♀N]) to&#xD;
      provide evidence-informed symptom triage and self-management support to reduce pain and&#xD;
      increase health-related quality of life (HRQoL) in women with heart disease. The&#xD;
      investigators will use the individual and family self-management theory, mobile device&#xD;
      functionality and the pervasive information architecture of mHealth interventions, and follow&#xD;
      the sequential phased approach recommended by the Medical Research Council (MRC) to develop&#xD;
      at heart (progressive WebApp). Funding was received from the Canadian Institutes of Health&#xD;
      Research to develop the architecture and conduct usability testing (Phase 2, complete) to&#xD;
      ensure it is easy to use, efficient and satisfying to operate. In Phase 3 (current proposal),&#xD;
      feasibility in terms of implementation (accrual rates, acceptability and level of engagement)&#xD;
      and initial estimation of effectiveness outcomes (estimates of magnitude of effect) will be&#xD;
      evaluated in a pilot randomized controlled trial (RCT). The Phase 3 pilot study will enable&#xD;
      the investigators to refine the prototype, inform the methodology, and calculate the sample&#xD;
      size for a larger multi-site RCT (Phase 4, future work).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase 3 (Study 3): Pilot Randomized Controlled Trial of the at heart (formerly called&#xD;
      HEARTPA♀N) Intervention.&#xD;
&#xD;
      The at heart intervention is the first of its kind; there are no previous trials of the&#xD;
      efficacy of such an intervention to decrease pain and improve HRQoL in women with heart&#xD;
      disease. The investigators will undertake a process and preliminary effect evaluation of the&#xD;
      intervention for women with heart disease, as guided by the MRC framework. The primary&#xD;
      objective is to determine the feasibility of implementing an RCT of the intervention. A&#xD;
      process evaluation will be conducted to examine: 1) the feasibility of randomization,&#xD;
      recruitment and retention, 2) acceptability and barriers to implementing the intervention&#xD;
      (including the symptom triage algorithms), and 3) the extent of engagement with the&#xD;
      intervention. The investigators will also undertake a preliminary efficacy evaluation of the&#xD;
      primary outcomes. Based on the investigator's theorized mechanism of change, they hypothesize&#xD;
      that the intervention will reduce pain and improve HRQoL (primary outcomes). The&#xD;
      investigators will assess the variability and sensitivity to change for both outcomes. Prior&#xD;
      to conducting a full scale RCT of a complex intervention, such as at heart, the MRC&#xD;
      recommends that a pilot trial be performed. Results from this pilot trial will inform the&#xD;
      success of a future RCT in three ways: 1) help determine sample size calculation for the&#xD;
      full-scale trial, 2) test procedures (recruitment, randomization, follow-up), which will make&#xD;
      up the design of the full-scale trial, and 3) test feasibility of implementing the&#xD;
      intervention, particularly by estimating rates of recruitment and retention. Triage&#xD;
      algorithms and self-management interventions will be developed using a strong theoretical&#xD;
      framework, informed by needs assessments and a comprehensive integrated mixed methods&#xD;
      systematic review, with preliminary acceptability and usability testing by end-users. The&#xD;
      investigators anticipate minimal risk to safety but will track adverse events using the&#xD;
      Adverse Event Form. Moreover, latest WebApp technologies have been integrated through the use&#xD;
      of a Chatbot named 'Holly'.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2021</start_date>
  <completion_date type="Anticipated">August 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2022</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>
    <intervention_model_description>A two group parallel single blind pilot RCT.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>It is not possible to blind the participants to group allocation due to the specific nature of the intervention; however, a data analyst at the University of Toronto's Faculty of Nursing who is blinded to treatment allocation will conduct the analysis ensuring neutrality of the outcome assessment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility (recruitment, retention, engagement)</measure>
    <time_frame>3 months</time_frame>
    <description>A process evaluation will be used to assess the feasibility of the implementation of the intervention. The PC will track any issues or difficulties encountered during trial implementation, such as problems using the app. Engagement will be assessed using Google Analytics, which will track patterns of app and website usage. Engagement with the app diary will be defined as 100% with daily entries for 3 months. Engagement with goal setting will be defined as 100% when 12 goals are identified over the 3-month period. Criteria for implementation success: recruitment rates &gt; 70%, retention &gt; 85%, minimal technical difficulties reported by &lt; 10%, engagement &gt; 80%, and minimal missed responses. Prevalence of refusal, retention, engagement and technical difficulties reported will be calculated with their 95% confidence intervals.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility (acceptability, satisfaction)</measure>
    <time_frame>3 months</time_frame>
    <description>The investigators will also assess acceptability and satisfaction in all participants in the intervention group using a modified Acceptability e-Scale (AES). The modified AES includes 9 items, each with a 5-point Likert response. Higher scores represent better acceptability/satisfaction. Responses are summed and averaged. Criteria for implementation success: AES mean summary score &gt; 4.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain (Brief Pain Inventory)</measure>
    <time_frame>3 months</time_frame>
    <description>A preliminary efficacy evaluation will also be undertaken focusing on the outcomes of pain. Pain will be measured using the Brief Pain Inventory-Short Form (BPI-SF), which rates pain severity and the degree to which pain interferes with mood, sleep, and other physical activities such as work, social activity and relations with others. We will investigate the variability and sensitivity to change for pain (T2-T1). We will calculate the number of participants who report clinically meaningful decreases in pain, which has been defined for the BPI-SF as a two-point difference in worst pain. Variability will be estimated using the mean/median scores and standard deviation, in each group separately, at pre and post-test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life (HRQOL)</measure>
    <time_frame>3 months</time_frame>
    <description>A preliminary efficacy evaluation will also be undertaken focusing on the outcomes of HRQOL. HRQOL will be measured using the SF-36v2TM, which contains 36 items and yields a score for each of the 8 domains of health: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role emotional), and mental health. We will investigate the variability and sensitivity to change for HRQOL (T2-T1). Sensitivity to change will be assessed by determining the number of participants who had a clinically meaningful increase in HRQOL: ≥ 15 points in physical functioning, general health and mental health; ≥ 16.7 in role emotional functioning; ≥ 18.5 points in role physical functioning and vitality; ≥ 20 points in bodily pain; and ≥ 25 points in social functioning.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">98</enrollment>
  <condition>Pain</condition>
  <condition>Cardiac Ischemia</condition>
  <condition>Women</condition>
  <condition>Pain, Chronic</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants allocated to the control group will receive the usual care and supports provided to women with cardiac pain, including usual clinic appointments and follow-up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants allocated to the treatment group will also learn how to use the progressive WebApp intervention. The intervention will be delivered on restricted password-protected applications that will permit tracking of adherence (number of logins to app and website using Google Analytics). Participants will be encouraged to log-in regularly to the progressive WebApp (via automated alerts) over the 3-month period to complete a Heart and/or Wellness Check. A Chatbot named 'Holly' will assist women with log-in and maintaining health and wellness. Participants will be directed to the PC for technical problems.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>at heart (changed from HEARTPA♀N during usability testing)</intervention_name>
    <description>An integrated smartphone and web-based intervention (at heart) to provide evidence-informed symptom triage and self-management support to reduce pain and increase health-related quality of life (HRQoL) in women with heart disease. The intervention for participants randomized to the treatment group will consist of regular use of a progressive WebApp that is managed by a Chatbot named 'Holly', in addition to usual care, for a period of 3 months.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women greater than 18 years of age with obstructive and non-obstructive CAD pain, post&#xD;
             PCI/cardiac surgery pain lasting greater than 3 months&#xD;
&#xD;
          -  women will be required to speak and read English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe cognitive impairment assessed using the Six-Item Screener&#xD;
&#xD;
          -  major co-morbid medical or psychiatric illness that could preclude their ability to&#xD;
             participate&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>We will use the PRAXY Gender Questionnaire - Short Form</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Monica Parry, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Toronto</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Monica Parry, PhD</last_name>
    <phone>416.946-3561</phone>
    <email>monica.parry@utoronto.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Myra Leyden, MA</last_name>
    <phone>416.978.1327</phone>
    <email>myra.leyden@utoronto.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Monica Parry</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 1P8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Monica Parry, PhD</last_name>
      <phone>416.946.3561</phone>
      <email>monica.parry@utoronto.ca</email>
    </contact>
    <contact_backup>
      <last_name>Arland O'Hara, BA</last_name>
      <email>arland.ohara@utoronto.ca</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>July 21, 2021</last_update_submitted>
  <last_update_submitted_qc>July 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Toronto</investigator_affiliation>
    <investigator_full_name>Monica Parry</investigator_full_name>
    <investigator_title>Associate Professor and Coordinator, Nurse Practitioner Programs</investigator_title>
  </responsible_party>
  <keyword>Women, Self-Management, Cardiac Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Ischemia</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03800082
org study id: 389044
nct id: NCT03800082
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall goal of this program of research is to develop and systematically evaluate an
      integrated smartphone and web-based intervention (at heart [formerly called HEARTPA♀N]) to
      provide evidence-informed symptom triage and self-management support to reduce pain and
      increase health-related quality of life (HRQoL) in women with heart disease. The
      investigators will use the individual and family self-management theory, mobile device
      functionality and the pervasive information architecture of mHealth interventions, and follow
      the sequential phased approach recommended by the Medical Research Council (MRC) to develop
      at heart (progressive WebApp). Funding was received from the Canadian Institutes of Health
      Research to develop the architecture and conduct usability testing (Phase 2, complete) to
      ensure it is easy to use, efficient and satisfying to operate. In Phase 3 (current proposal),
      feasibility in terms of implementation (accrual rates, acceptability and level of engagement)
      and initial estimation of effectiveness outcomes (estimates of magnitude of effect) will be
      evaluated in a pilot randomized controlled trial (RCT). The Phase 3 pilot study will enable
      the investigators to refine the prototype, inform the methodology, and calculate the sample
      size for a larger multi-site RCT (Phase 4, future work).
Phase 3 (Study 3): Pilot Randomized Controlled Trial of the at heart (formerly called
      HEARTPA♀N) Intervention.

      The at heart intervention is the first of its kind; there are no previous trials of the
      efficacy of such an intervention to decrease pain and improve HRQoL in women with heart
      disease. The investigators will undertake a process and preliminary effect evaluation of the
      intervention for women with heart disease, as guided by the MRC framework. The primary
      objective is to determine the feasibility of implementing an RCT of the intervention. A
      process evaluation will be conducted to examine: 1) the feasibility of randomization,
      recruitment and retention, 2) acceptability and barriers to implementing the intervention
      (including the symptom triage algorithms), and 3) the extent of engagement with the
      intervention. The investigators will also undertake a preliminary efficacy evaluation of the
      primary outcomes. Based on the investigator's theorized mechanism of change, they hypothesize
      that the intervention will reduce pain and improve HRQoL (primary outcomes). The
      investigators will assess the variability and sensitivity to change for both outcomes. Prior
      to conducting a full scale RCT of a complex intervention, such as at heart, the MRC
      recommends that a pilot trial be performed. Results from this pilot trial will inform the
      success of a future RCT in three ways: 1) help determine sample size calculation for the
      full-scale trial, 2) test procedures (recruitment, randomization, follow-up), which will make
      up the design of the full-scale trial, and 3) test feasibility of implementing the
      intervention, particularly by estimating rates of recruitment and retention. Triage
      algorithms and self-management interventions will be developed using a strong theoretical
      framework, informed by needs assessments and a comprehensive integrated mixed methods
      systematic review, with preliminary acceptability and usability testing by end-users. The
      investigators anticipate minimal risk to safety but will track adverse events using the
      Adverse Event Form. Moreover, latest WebApp technologies have been integrated through the use
      of a Chatbot named 'Holly'.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A two group parallel single blind pilot RCT.
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: It is not possible to blind the participants to group allocation due to the specific nature of the intervention; however, a data analyst at the University of Toronto's Faculty of Nursing who is blinded to treatment allocation will conduct the analysis ensuring neutrality of the outcome assessment.
measure: Feasibility (recruitment, retention, engagement)
time frame: 3 months
description: A process evaluation will be used to assess the feasibility of the implementation of the intervention. The PC will track any issues or difficulties encountered during trial implementation, such as problems using the app. Engagement will be assessed using Google Analytics, which will track patterns of app and website usage. Engagement with the app diary will be defined as 100% with daily entries for 3 months. Engagement with goal setting will be defined as 100% when 12 goals are identified over the 3-month period. Criteria for implementation success: recruitment rates > 70%, retention > 85%, minimal technical difficulties reported by < 10%, engagement > 80%, and minimal missed responses. Prevalence of refusal, retention, engagement and technical difficulties reported will be calculated with their 95% confidence intervals.
measure: Feasibility (acceptability, satisfaction)
time frame: 3 months
description: The investigators will also assess acceptability and satisfaction in all participants in the intervention group using a modified Acceptability e-Scale (AES). The modified AES includes 9 items, each with a 5-point Likert response. Higher scores represent better acceptability/satisfaction. Responses are summed and averaged. Criteria for implementation success: AES mean summary score > 4.
measure: Pain (Brief Pain Inventory)
time frame: 3 months
description: A preliminary efficacy evaluation will also be undertaken focusing on the outcomes of pain. Pain will be measured using the Brief Pain Inventory-Short Form (BPI-SF), which rates pain severity and the degree to which pain interferes with mood, sleep, and other physical activities such as work, social activity and relations with others. We will investigate the variability and sensitivity to change for pain (T2-T1). We will calculate the number of participants who report clinically meaningful decreases in pain, which has been defined for the BPI-SF as a two-point difference in worst pain. Variability will be estimated using the mean/median scores and standard deviation, in each group separately, at pre and post-test.
measure: Health-related quality of life (HRQOL)
time frame: 3 months
description: A preliminary efficacy evaluation will also be undertaken focusing on the outcomes of HRQOL. HRQOL will be measured using the SF-36v2TM, which contains 36 items and yields a score for each of the 8 domains of health: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role emotional), and mental health. We will investigate the variability and sensitivity to change for HRQOL (T2-T1). Sensitivity to change will be assessed by determining the number of participants who had a clinically meaningful increase in HRQOL: ≥ 15 points in physical functioning, general health and mental health; ≥ 16.7 in role emotional functioning; ≥ 18.5 points in role physical functioning and vitality; ≥ 20 points in bodily pain; and ≥ 25 points in social functioning.
arm group label: Control
arm group type: No Intervention
description: Participants allocated to the control group will receive the usual care and supports provided to women with cardiac pain, including usual clinic appointments and follow-up.
arm group label: Treatment
arm group type: Experimental
description: Participants allocated to the treatment group will also learn how to use the progressive WebApp intervention. The intervention will be delivered on restricted password-protected applications that will permit tracking of adherence (number of logins to app and website using Google Analytics). Participants will be encouraged to log-in regularly to the progressive WebApp (via automated alerts) over the 3-month period to complete a Heart and/or Wellness Check. A Chatbot named 'Holly' will assist women with log-in and maintaining health and wellness. Participants will be directed to the PC for technical problems.
intervention type: Behavioral
intervention name: at heart (changed from HEARTPA♀N during usability testing)
description: An integrated smartphone and web-based intervention (at heart) to provide evidence-informed symptom triage and self-management support to reduce pain and increase health-related quality of life (HRQoL) in women with heart disease. The intervention for participants randomized to the treatment group will consist of regular use of a progressive WebApp that is managed by a Chatbot named 'Holly', in addition to usual care, for a period of 3 months.
arm group label: Treatment
criteria: 
gender: Female
gender based: Yes
gender description: We will use the PRAXY Gender Questionnaire - Short Form
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Monica Parry, PhD
role: Principal Investigator
affiliation: University of Toronto
last name: Monica Parry, PhD
phone: 416.946-3561
email: monica.parry@utoronto.ca
last name: Myra Leyden, MA
phone: 416.978.1327
email: myra.leyden@utoronto.ca
facility: 
status: Recruiting
contact: 
contact backup: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Toronto
investigator full name: Monica Parry
investigator title: Associate Professor and Coordinator, Nurse Practitioner Programs
mesh term: Heart Diseases
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Ischemia
mesh term: Chronic Pain
sharing ipd: No