<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/NCT03768401</url>
  </required_header>
  <id_info>
    <org_study_id>17-008524</org_study_id>
    <nct_id>NCT03768401</nct_id>
  </id_info>
  <brief_title>Accessible Mobile Health and Wellness</brief_title>
  <acronym>CHAMPs</acronym>
  <official_title>Accessible Mobile Health and Wellness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kristin Zhao, PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Southeastern Minnesota Center for Independent Living</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mayo Clinic</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>
      Can community outreach education help develop self-sustaining wellness and exercise programs,&#xD;
      and will associated wellness clinics help persons with a neurological physical disability&#xD;
      achieve better well-being?&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Funding/grant expired.&#xD;
  </why_stopped>
  <start_date type="Actual">August 1, 2018</start_date>
  <completion_date type="Actual">December 21, 2018</completion_date>
  <primary_completion_date type="Actual">December 21, 2018</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of new self-sustaining wellness and exercise programs</measure>
    <time_frame>3 months post end of wellness clinics</time_frame>
    <description>Incidence of new self-sustaining wellness and exercise programs, as determined by Follow-up Site Staff Survey</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy of seminars for individuals with a neurological physical disability</measure>
    <time_frame>3 months post end of wellness clinics</time_frame>
    <description>Efficacy of seminars, as determined by repeated t-tests based on the Exercise Self-Efficacy Survey (ESES), a 10-question survey with scores of 1 to 4 (with 4 being the best outcome), summed for a minimum score of 10, and a maximum score of 40.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of seminars for caregivers and clinic staff of patients with neurological physical disabilities</measure>
    <time_frame>3 months post end of wellness clinics</time_frame>
    <description>Efficacy of seminars, as determined by repeated t-tests based on the Exercise Efficacy for Caregivers and Staff, a 10-question survey with scores of 1 to 4 (with 4 being the best outcome), summed for a minimum score of 10, and a maximum score of 40.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of wellness clinics</measure>
    <time_frame>3 months post end of wellness clinics</time_frame>
    <description>Efficacy of wellness clinics, as determined by repeated t-tests</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Physical Disability</condition>
  <condition>Neurologic Dysfunction</condition>
  <arm_group>
    <arm_group_label>Educational Seminars and Wellness Clinics</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>I. Community outreach educational seminars about wellness and exercise while living with a neurological physical disability and measurement of the effects of these seminars for training individuals with neurological physical disabilities and their care givers (family, therapists, community personal trainers and community funders such as Lions or Rotary Clubs) about how to create a safe cost-effective exercise program .&#xD;
II. Creation and measurement of the effects of a wellness clinic for those with a neurological physical disability.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Education</intervention_name>
    <description>Seminars about wellness and exercise, and resulting therapeutic programs, while living with a neurological physical disability.</description>
    <arm_group_label>Educational Seminars and Wellness Clinics</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Trial Exercise Modalities</intervention_name>
    <description>Wellness/exercise clinics located at Mayo Clinic, Rochester will be offered to persons with neurological physical disabilities on a regular basis, at least monthly, during the last half of the trial period.</description>
    <arm_group_label>Educational Seminars and Wellness Clinics</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  [for community participants/caregivers/family members] Ability to demonstrate clear&#xD;
             communication and understanding of English.&#xD;
&#xD;
          -  [for participants with neurological physical conditions] Neurological physical&#xD;
             conditions including cerebral palsy, spinal cord injury, stroke, multiple sclerosis,&#xD;
             or similar diagnoses&#xD;
&#xD;
          -  [for educational seminars] &gt; 6 years of age.&#xD;
&#xD;
          -  [for wellness/exercise clinic] 18 65 years of age&#xD;
&#xD;
          -  [for wellness/exercise clinic; participants with neurological physical conditions]&#xD;
             Clearance by primary care or treating physician&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  [for participants with neurological physical conditions] Unstable fractures&#xD;
&#xD;
          -  [for participants with neurological physical conditions] Uncontrolled hypertension&#xD;
             (combined systolic/diastolic &gt; 140/90 mmHg)&#xD;
&#xD;
          -  [for participants with neurological physical conditions] Enrollment of individual&#xD;
             deemed by study staff to be unsafe&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristin D Zhao</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <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_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>April 2019</verification_date>
  <study_first_submitted>July 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>April 28, 2019</last_update_submitted>
  <last_update_submitted_qc>April 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Kristin Zhao, PhD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neurologic Manifestations</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/NCT03768401
org study id: 17-008524
nct id: NCT03768401
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Can community outreach education help develop self-sustaining wellness and exercise programs,
      and will associated wellness clinics help persons with a neurological physical disability
      achieve better well-being?
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Incidence of new self-sustaining wellness and exercise programs
time frame: 3 months post end of wellness clinics
description: Incidence of new self-sustaining wellness and exercise programs, as determined by Follow-up Site Staff Survey
measure: Efficacy of seminars for individuals with a neurological physical disability
time frame: 3 months post end of wellness clinics
description: Efficacy of seminars, as determined by repeated t-tests based on the Exercise Self-Efficacy Survey (ESES), a 10-question survey with scores of 1 to 4 (with 4 being the best outcome), summed for a minimum score of 10, and a maximum score of 40.
measure: Efficacy of seminars for caregivers and clinic staff of patients with neurological physical disabilities
time frame: 3 months post end of wellness clinics
description: Efficacy of seminars, as determined by repeated t-tests based on the Exercise Efficacy for Caregivers and Staff, a 10-question survey with scores of 1 to 4 (with 4 being the best outcome), summed for a minimum score of 10, and a maximum score of 40.
measure: Efficacy of wellness clinics
time frame: 3 months post end of wellness clinics
description: Efficacy of wellness clinics, as determined by repeated t-tests
arm group label: Educational Seminars and Wellness Clinics
arm group type: Experimental
description: I. Community outreach educational seminars about wellness and exercise while living with a neurological physical disability and measurement of the effects of these seminars for training individuals with neurological physical disabilities and their care givers (family, therapists, community personal trainers and community funders such as Lions or Rotary Clubs) about how to create a safe cost-effective exercise program .
II. Creation and measurement of the effects of a wellness clinic for those with a neurological physical disability.
intervention type: Other
intervention name: Education
description: Seminars about wellness and exercise, and resulting therapeutic programs, while living with a neurological physical disability.
arm group label: Educational Seminars and Wellness Clinics
intervention type: Behavioral
intervention name: Trial Exercise Modalities
description: Wellness/exercise clinics located at Mayo Clinic, Rochester will be offered to persons with neurological physical disabilities on a regular basis, at least monthly, during the last half of the trial period.
arm group label: Educational Seminars and Wellness Clinics
criteria: 
gender: All
minimum age: 6 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kristin D Zhao
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Sponsor-Investigator
investigator affiliation: Mayo Clinic
investigator full name: Kristin Zhao, PhD
investigator title: Principal Investigator
mesh term: Neurologic Manifestations
sharing ipd: No