<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/NCT03276546</url>
  </required_header>
  <id_info>
    <org_study_id>16/LO/0655</org_study_id>
    <nct_id>NCT03276546</nct_id>
  </id_info>
  <brief_title>SHARE-D: a Decision Tool to Help Patients Make Informed Lifestyle Choices</brief_title>
  <acronym>SHARE-D</acronym>
  <official_title>SHARE-D: a Decision Tool to Help Patients With, or at Risk of, Coronary Heart Disease Make Informed Lifestyle Choices: Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queen's University, Belfast</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Northern Ireland Chest Heart and Stroke</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Queen's University, Belfast</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>
      More information is needed about effective ways to help people begin to change their&#xD;
      lifestyle behaviours, particularly physical activity and diet. The investigators propose to&#xD;
      test a 'tool' that can be used to guide discussions between people and health professionals&#xD;
      about their physical activity and diet habits, so that people may be supported better in&#xD;
      making decisions about why and how they might begin to fit more exercise and healthy food&#xD;
      into their daily routines and make long-term changes. The investigators will explore the&#xD;
      feasibility of using this tool in general practice, reviewing behaviours after 1 and 3&#xD;
      months. Patients' and healthcare professionals' views of its use and how it influenced&#xD;
      decisions will inform development of the tool's design and a study of its effectiveness in&#xD;
      helping people to begin to change their behaviour and achieve healthy lifestyles.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Healthier lifestyles, relating to physical activity and diet, reduce the risk of heart&#xD;
      disease and stroke. However, making and sustaining lifestyle changes is difficult. More&#xD;
      information is needed about effective ways to help people begin to change their lifestyle&#xD;
      behaviours. The investigators propose to test the feasibility of using a 'tool' in guiding&#xD;
      discussions between people and health professionals about physical activity and diet, and&#xD;
      support people in making decisions about why and how they might begin to fit more exercise&#xD;
      and healthy food into their daily routines. The 'tool' consists of questions to help people&#xD;
      think about their personal circumstances and their motivation, opportunities, capabilities&#xD;
      and priorities, and includes information about heart disease and stroke.&#xD;
&#xD;
      The investigators will explore the use of this tool in general practice, assessing patients'&#xD;
      physical activity and diet behaviour after 1 and 3 months. Patients' and healthcare&#xD;
      professionals' views of its use and how it influenced decisions will help to improve the&#xD;
      tool's design. Participants' opinions regarding its format and method of delivery will inform&#xD;
      future plans for its use and the design of a study of its effectiveness in helping people to&#xD;
      begin to change their behaviour and achieve healthy lifestyles, hoping to lead to improved&#xD;
      quality of life for people with heart disease and stroke.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2016</start_date>
  <completion_date type="Actual">January 31, 2017</completion_date>
  <primary_completion_date type="Actual">January 31, 2017</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>recruitment rate</measure>
    <time_frame>4 weeks</time_frame>
    <description>numbers of responses accepting invitation to participate in study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>completion rate</measure>
    <time_frame>3 months</time_frame>
    <description>numbers of enrolled participants who compete all assessments and reviews</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>diet behaviour</measure>
    <time_frame>3 months</time_frame>
    <description>DINE questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>physical activity behaviour</measure>
    <time_frame>3 months</time_frame>
    <description>RPAQ questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>objective measure of physical activity</measure>
    <time_frame>2 periods of 7-day measurement: baseline and after 3 months</time_frame>
    <description>accelerometer</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Health Behavior</condition>
  <arm_group>
    <arm_group_label>SHARE-D decision tool use</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention, a shared decision-making tool ('SHARE-D'), which is a paper-based questionnaire, will be used jointly by a health professional and patient to facilitate decision-making about initiating change in physical activity or diet behaviour</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>shared decision-making tool (SHARE-D)</intervention_name>
    <description>questionnaire</description>
    <arm_group_label>SHARE-D decision tool use</arm_group_label>
    <other_name>questionnaire</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 years or over&#xD;
&#xD;
          -  With or at high risk of coronary heart disease&#xD;
&#xD;
          -  Overweight or physically inactive&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to complete questionnaires&#xD;
&#xD;
          -  Unable to make independent changes to physical activity or diet habits&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>May 15, 2018</last_update_submitted>
  <last_update_submitted_qc>May 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Queen's University, Belfast</investigator_affiliation>
    <investigator_full_name>Dr Margaret E Cupples</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <pending_results>
    <submitted>February 17, 2022</submitted>
    <returned>April 25, 2022</returned>
    <submitted>April 9, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03276546
org study id: 16/LO/0655
nct id: NCT03276546
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
More information is needed about effective ways to help people begin to change their
      lifestyle behaviours, particularly physical activity and diet. The investigators propose to
      test a 'tool' that can be used to guide discussions between people and health professionals
      about their physical activity and diet habits, so that people may be supported better in
      making decisions about why and how they might begin to fit more exercise and healthy food
      into their daily routines and make long-term changes. The investigators will explore the
      feasibility of using this tool in general practice, reviewing behaviours after 1 and 3
      months. Patients' and healthcare professionals' views of its use and how it influenced
      decisions will inform development of the tool's design and a study of its effectiveness in
      helping people to begin to change their behaviour and achieve healthy lifestyles.
Healthier lifestyles, relating to physical activity and diet, reduce the risk of heart
      disease and stroke. However, making and sustaining lifestyle changes is difficult. More
      information is needed about effective ways to help people begin to change their lifestyle
      behaviours. The investigators propose to test the feasibility of using a 'tool' in guiding
      discussions between people and health professionals about physical activity and diet, and
      support people in making decisions about why and how they might begin to fit more exercise
      and healthy food into their daily routines. The 'tool' consists of questions to help people
      think about their personal circumstances and their motivation, opportunities, capabilities
      and priorities, and includes information about heart disease and stroke.

      The investigators will explore the use of this tool in general practice, assessing patients'
      physical activity and diet behaviour after 1 and 3 months. Patients' and healthcare
      professionals' views of its use and how it influenced decisions will help to improve the
      tool's design. Participants' opinions regarding its format and method of delivery will inform
      future plans for its use and the design of a study of its effectiveness in helping people to
      begin to change their behaviour and achieve healthy lifestyles, hoping to lead to improved
      quality of life for people with heart disease and stroke.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: recruitment rate
time frame: 4 weeks
description: numbers of responses accepting invitation to participate in study
measure: completion rate
time frame: 3 months
description: numbers of enrolled participants who compete all assessments and reviews
measure: diet behaviour
time frame: 3 months
description: DINE questionnaire
measure: physical activity behaviour
time frame: 3 months
description: RPAQ questionnaire
measure: objective measure of physical activity
time frame: 2 periods of 7-day measurement: baseline and after 3 months
description: accelerometer
arm group label: SHARE-D decision tool use
arm group type: Experimental
description: The intervention, a shared decision-making tool ('SHARE-D'), which is a paper-based questionnaire, will be used jointly by a health professional and patient to facilitate decision-making about initiating change in physical activity or diet behaviour
intervention type: Behavioral
intervention name: shared decision-making tool (SHARE-D)
description: questionnaire
arm group label: SHARE-D decision tool use
other name: questionnaire
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Queen's University, Belfast
investigator full name: Dr Margaret E Cupples
investigator title: Professor
submitted: February 17, 2022
returned: April 25, 2022
submitted: April 9, 2023