<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/NCT03017196</url>
  </required_header>
  <id_info>
    <org_study_id>16-007340</org_study_id>
    <nct_id>NCT03017196</nct_id>
  </id_info>
  <brief_title>My Life, My Healthcare</brief_title>
  <official_title>My Life, My Healthcare</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gordon and Betty Moore Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to answer the following questions: &quot;Is the My Life, My Healthcare&#xD;
      Discussion Aid feasible for use in primary care? Does it positively impact patient and&#xD;
      healthcare teams' care experience and communication, while reducing patient treatment&#xD;
      burden?&quot;&#xD;
&#xD;
      Through implementation of the My Life, My Healthcare Discussion Aid for patients with chronic&#xD;
      conditions, the study team hypothesizes that it will be feasible to implement in routine&#xD;
      primary care practice and positively impact patient and healthcare teams experience of&#xD;
      chronic care, while reducing patient treatment burden.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">July 2019</completion_date>
  <primary_completion_date type="Actual">July 2019</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>Patient Assessment of Chronic Illness Care (PACIC)</measure>
    <time_frame>6 months</time_frame>
    <description>The 20-item scale measures goal setting, coordination of care, decision support, problem solving, and patient activation, and prompts the patient to reflect with items such as: &quot;Over the past 6 months, when I received care for my chronic conditions, I was: helped to make a treatment plan that I could carry out in my daily life.&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Illness Intrusiveness Scale</measure>
    <time_frame>6 months</time_frame>
    <description>This identifies the extent to which the treatment regimen interferes with life by asking &quot;How much does your illness and/or its treatment interfere with...&quot; things like &quot;your work, including job, house work, chores, or errands?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General Self-Rated Health</measure>
    <time_frame>6 months</time_frame>
    <description>&quot;In general, would you say your health is: Excellent, Very Good, Good, Fair, Poor?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Communicate with Physician Self-Efficacy Subscale</measure>
    <time_frame>6 months</time_frame>
    <description>This 3-item scale has been used in work by Lorig et al. for chronic disease, and asks questions such as &quot;How confident are you that you can discuss openly with your doctor any personal problems that may be related to your illness?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consultation Care Measure</measure>
    <time_frame>6 months</time_frame>
    <description>This 20-item scale is a valid and discriminating tool to measure communication and partnership, personal relationship, health promotion, positive and clear approach to the problem, and interest in effect of healthcare on patient's life within a single pat</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy to Manage Disease in General Subscale</measure>
    <time_frame>6 months</time_frame>
    <description>asks questions such as &quot;How confident are you that you can do all the things necessary to manage your condition on a regular basis?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Burden Questionnaire (TBQ)</measure>
    <time_frame>6 months</time_frame>
    <description>The questionnaire measures the perceived burden of taking medications, self-monitoring and other self-management activities by asking participants to rate the impact of these tasks on a scale from 1-10 with items such as: &quot;The taste, shape or size of your tablets and/or the annoyances caused by your injections (e.g., pain, bleeding, bruising or scars).&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relational Coordination of Care Team</measure>
    <time_frame>6 months</time_frame>
    <description>assesses seven domains of coordinated teams: frequent, timely, accurate, and problem-solving communication, shared goals, shared knowledge, and mutual respect.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Care Team Assessment of Chronic Illness Care (ACIC)</measure>
    <time_frame>6 months</time_frame>
    <description>Measures clinician, coach, and clinical team satisfaction with care delivery.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1929</enrollment>
  <condition>Chronic Disease</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sites randomized to intervention will be expected to implement the My Life, My Healthcare Discussion Aid in their practice for at least a 6-month period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Sites randomized to control will not be expected to implement the My Life, My Healthcare Discussion Aid in practice. They will be expected to practice chronic care as usual.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>My Life, My Healthcare Discussion Aid</intervention_name>
    <description>The My Life, My Healthcare instrument is a conversational tool designed to help patients and clinicians discuss capacity in clinical conversations of primary care.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        InclusionCriteria: Particpant population will include patients 18 years of age or older who&#xD;
        have one or more chronic conditions and do not have any barriers to consent (such as major&#xD;
        cognitive disabilities) will be eligible for enrollment. Clinicians who treat patients with&#xD;
        chronic conditions at participating sites are eligible for enrollment.&#xD;
&#xD;
        Exclusion Criteria: Patients who do not have a chronic condition, or have barriers to&#xD;
        consent such as cognitive impairment will be excluded from the study. Health professionals&#xD;
        who do not treat patients with chronic conditions will not be included.&#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>
  <overall_official>
    <last_name>Kasey R. Boehmer, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Primary Care Centers of East Kentucky</name>
      <address>
        <city>Hazard</city>
        <state>Kentucky</state>
        <zip>41701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lewis County Primary Care Center, Inc.</name>
      <address>
        <city>Vanceburg</city>
        <state>Kentucky</state>
        <zip>41179</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Health System - Springfield</name>
      <address>
        <city>Springfield</city>
        <state>Minnesota</state>
        <zip>56087</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vidant Multispecialty Clinic Belhaven</name>
      <address>
        <city>Belhaven</city>
        <state>North Carolina</state>
        <zip>27810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elizabeth Family Medicine</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CMC- Union Family Medicine</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vidant Family Medicine Chocowinity</name>
      <address>
        <city>Chocowinity</city>
        <state>North Carolina</state>
        <zip>28717</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Health System La Crosse</name>
      <address>
        <city>La Crosse</city>
        <state>Wisconsin</state>
        <zip>54601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>June 3, 2020</last_update_submitted>
  <last_update_submitted_qc>June 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Kasey R. Boehmer</investigator_full_name>
    <investigator_title>M.P.H.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Disease</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/NCT03017196
org study id: 16-007340
nct id: NCT03017196
lead sponsor: 
collaborator: 
has dmc: No
This study is designed to answer the following questions: "Is the My Life, My Healthcare
      Discussion Aid feasible for use in primary care? Does it positively impact patient and
      healthcare teams' care experience and communication, while reducing patient treatment
      burden?"

      Through implementation of the My Life, My Healthcare Discussion Aid for patients with chronic
      conditions, the study team hypothesizes that it will be feasible to implement in routine
      primary care practice and positively impact patient and healthcare teams experience of
      chronic care, while reducing patient treatment burden.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Patient Assessment of Chronic Illness Care (PACIC)
time frame: 6 months
description: The 20-item scale measures goal setting, coordination of care, decision support, problem solving, and patient activation, and prompts the patient to reflect with items such as: "Over the past 6 months, when I received care for my chronic conditions, I was: helped to make a treatment plan that I could carry out in my daily life."
measure: Illness Intrusiveness Scale
time frame: 6 months
description: This identifies the extent to which the treatment regimen interferes with life by asking "How much does your illness and/or its treatment interfere with..." things like "your work, including job, house work, chores, or errands?"
measure: General Self-Rated Health
time frame: 6 months
description: "In general, would you say your health is: Excellent, Very Good, Good, Fair, Poor?"
measure: Communicate with Physician Self-Efficacy Subscale
time frame: 6 months
description: This 3-item scale has been used in work by Lorig et al. for chronic disease, and asks questions such as "How confident are you that you can discuss openly with your doctor any personal problems that may be related to your illness?"
measure: Consultation Care Measure
time frame: 6 months
description: This 20-item scale is a valid and discriminating tool to measure communication and partnership, personal relationship, health promotion, positive and clear approach to the problem, and interest in effect of healthcare on patient's life within a single pat
measure: Self-efficacy to Manage Disease in General Subscale
time frame: 6 months
description: asks questions such as "How confident are you that you can do all the things necessary to manage your condition on a regular basis?"
measure: Treatment Burden Questionnaire (TBQ)
time frame: 6 months
description: The questionnaire measures the perceived burden of taking medications, self-monitoring and other self-management activities by asking participants to rate the impact of these tasks on a scale from 1-10 with items such as: "The taste, shape or size of your tablets and/or the annoyances caused by your injections (e.g., pain, bleeding, bruising or scars)."
measure: Relational Coordination of Care Team
time frame: 6 months
description: assesses seven domains of coordinated teams: frequent, timely, accurate, and problem-solving communication, shared goals, shared knowledge, and mutual respect.
measure: Care Team Assessment of Chronic Illness Care (ACIC)
time frame: 6 months
description: Measures clinician, coach, and clinical team satisfaction with care delivery.
arm group label: Intervention
arm group type: Experimental
description: Sites randomized to intervention will be expected to implement the My Life, My Healthcare Discussion Aid in their practice for at least a 6-month period.
arm group label: Control
arm group type: No Intervention
description: Sites randomized to control will not be expected to implement the My Life, My Healthcare Discussion Aid in practice. They will be expected to practice chronic care as usual.
intervention type: Other
intervention name: My Life, My Healthcare Discussion Aid
description: The My Life, My Healthcare instrument is a conversational tool designed to help patients and clinicians discuss capacity in clinical conversations of primary care.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kasey R. Boehmer, MPH
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Kasey R. Boehmer
investigator title: M.P.H.
mesh term: Chronic Disease