<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/NCT04423666</url>
  </required_header>
  <id_info>
    <org_study_id>BostonCollege</org_study_id>
    <nct_id>NCT04423666</nct_id>
  </id_info>
  <brief_title>Findings of a Health-coached Technology Based Walking Program in Unpaid Caregivers of Persons With Dementia</brief_title>
  <official_title>Findings of a Health-coached Technology Based Walking Program in Unpaid Caregivers of Persons With Dementia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston College</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>
      This study aims to:&#xD;
&#xD;
        1. Establish the feasibility of a health-coached (HC) walking program utilizing&#xD;
           motivational interviewing (MI) and wireless pedometers in family caregivers of persons&#xD;
           with dementia.&#xD;
&#xD;
        2. Examine preliminary outcomes of a HC walking program utilizing MI with wireless&#xD;
           pedometers on family caregiver's perception of wellbeing, stress, and activity level.&#xD;
&#xD;
        3. Explore caregivers' acceptability and experience of participating in a HC walking&#xD;
           program utilizing MI with wireless pedometers and to explore additional person centered&#xD;
           approaches.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This comparative study will use a two group repeated measure design and mixed methods&#xD;
      approach including well-validated questionnaires and qualitative descriptive methodology.&#xD;
      Qualitative inquiry will provide data about the overall experience of caregivers in the&#xD;
      intervention arm as well as inform web-based, person centered approaches as suggested by&#xD;
      caregivers that will be used to inform future work on person-centered self-care strategies,&#xD;
      aimed at improving caregiver health. Eligibility Criteria: having approval from the primary&#xD;
      care provider to initiate a walking program, being a caregiver of a person with dementia,&#xD;
      being greater than 18 years of age and having access to a computer or smartphone. &quot;The &quot;RSVP&#xD;
      [research volunteer program] for Health,&quot; a registry comprised of individuals interested in&#xD;
      receiving information on research studies conducted at Massachusetts General Hospital (MGH),&#xD;
      will be utilized for recruitment. If a person states they are interested, they will be called&#xD;
      to set up a screening visit to determine study eligibility at which time they will be given&#xD;
      the IRB consent to review and a baseline visit will be set up.&#xD;
&#xD;
      At the baseline visit, the consent will be reviewed by the Principal Investigator (PI) and&#xD;
      signed by participants meeting eligibility criteria. A member of the study team will obtain&#xD;
      demographic and caregiver health characteristics and complete study questionnaires. After&#xD;
      baseline measures are obtained, the study team will: 1) provide all participants with&#xD;
      education about the CDC physical activity recommendations for adults, 2) set participants up&#xD;
      with a wireless pedometer and 3) invite them to join a walking group on-line where they can&#xD;
      monitor their activity as compared to others in the intervention arm. Members of the study&#xD;
      team will then provide participants in the intervention arm with health coaching (HC)&#xD;
      utilizing motivational interviewing (MI) weekly for 8 weeks by email, text message or&#xD;
      telephone. The mode of delivery for the MI will be based on participant preference. The&#xD;
      control group will be able to view the web page and monitor their activity compared to others&#xD;
      in the control group arm, but will receive no coaching.&quot; At the end of the 8 weeks, study&#xD;
      measures will be again be obtained in both groups. The PI will conduct semi-structured&#xD;
      qualitative interviews with participants in the intervention arm to evaluate acceptability&#xD;
      and acquire feedback on the intervention and ideas for other self-care strategies.&quot; Caregiver&#xD;
      Measures Pre - Post&#xD;
&#xD;
        1. Demographic variables&#xD;
&#xD;
        2. General health characteristics&#xD;
&#xD;
        3. Well-being&#xD;
&#xD;
        4. Perceived stress&#xD;
&#xD;
        5. Mini-cog&#xD;
&#xD;
        6. Perceived Steps And post, a qualitative interview&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Actual">October 1, 2019</completion_date>
  <primary_completion_date type="Actual">October 1, 2019</primary_completion_date>
  <phase>Phase 1</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>Convenience sample, randomized, intervention, pre-post design</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants were randomly assigned through a toss of a coin to either the intervention or control</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>8 weeks</time_frame>
    <description>systolic/diastolic</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pulse rate will be combined to report BMI in kg/m^2BMI</measure>
    <time_frame>8 weeks</time_frame>
    <description>count of pulse rate for one minute</description>
  </primary_outcome>
  <primary_outcome>
    <measure>height</measure>
    <time_frame>8 weeks</time_frame>
    <description>in meters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>weight</measure>
    <time_frame>8 weeks</time_frame>
    <description>in kg</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BMI</measure>
    <time_frame>8 weeks</time_frame>
    <description>weight and height will be combined to report BMI in kg/m^2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>wellbeing</measure>
    <time_frame>8 weeks</time_frame>
    <description>self report using 7 item Warwick wellbeing where 1 is none to 5 is all of the time (more positive reponse)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress level</measure>
    <time_frame>8 weeks</time_frame>
    <description>self report using 10-item Perceived Stress Scale where 1 is no stress to 4 is highest level of stress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Qualitative Descriptive</measure>
    <time_frame>At end of 8 weeks</time_frame>
    <description>interviews</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will receive:&#xD;
education&#xD;
a wireless pedometer with set up&#xD;
nurse coaching via text message, email or telephone based on participant preference and at frequency determined by the participant</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Will receive:&#xD;
education&#xD;
a wireless pedometer with set up</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Walking using a wireless pedometer</intervention_name>
    <description>See arm/group</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria - must have/be:&#xD;
&#xD;
        Approval from the primary care provider to initiate a walking program A caregiver of a&#xD;
        person with dementia Greater than age 18 Access access to a computer or smartphone.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Not being able to commit to an 8 week walking program&#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>Jane Flanagan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston College</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</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>
  <link>
    <url>https://academic.oup.com/innovateage/article/3/Supplement_1/S288/5615604</url>
    <description>Geriatric Society of America Conference Proceedings</description>
  </link>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 5, 2020</last_update_submitted>
  <last_update_submitted_qc>June 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>caregiver</keyword>
  <keyword>dementia</keyword>
  <keyword>wellbeing</keyword>
  <keyword>stress</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The Pi will make available upon request the study protocol, SAP, ICF and CSR and as possible these will be shared via dissemination of the findings.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>April 2020 - indefinitely</ipd_time_frame>
    <ipd_access_criteria>notify PI</ipd_access_criteria>
    <ipd_url>http://www.bc.edu/bc-web/schools/cson/faculty-research/faculty-directory/jane-m--flanagan.html</ipd_url>
  </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/NCT04423666
org study id: BostonCollege
nct id: NCT04423666
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to:

        1. Establish the feasibility of a health-coached (HC) walking program utilizing
           motivational interviewing (MI) and wireless pedometers in family caregivers of persons
           with dementia.

        2. Examine preliminary outcomes of a HC walking program utilizing MI with wireless
           pedometers on family caregiver's perception of wellbeing, stress, and activity level.

        3. Explore caregivers' acceptability and experience of participating in a HC walking
           program utilizing MI with wireless pedometers and to explore additional person centered
           approaches.
This comparative study will use a two group repeated measure design and mixed methods
      approach including well-validated questionnaires and qualitative descriptive methodology.
      Qualitative inquiry will provide data about the overall experience of caregivers in the
      intervention arm as well as inform web-based, person centered approaches as suggested by
      caregivers that will be used to inform future work on person-centered self-care strategies,
      aimed at improving caregiver health. Eligibility Criteria: having approval from the primary
      care provider to initiate a walking program, being a caregiver of a person with dementia,
      being greater than 18 years of age and having access to a computer or smartphone. "The "RSVP
      [research volunteer program] for Health," a registry comprised of individuals interested in
      receiving information on research studies conducted at Massachusetts General Hospital (MGH),
      will be utilized for recruitment. If a person states they are interested, they will be called
      to set up a screening visit to determine study eligibility at which time they will be given
      the IRB consent to review and a baseline visit will be set up.

      At the baseline visit, the consent will be reviewed by the Principal Investigator (PI) and
      signed by participants meeting eligibility criteria. A member of the study team will obtain
      demographic and caregiver health characteristics and complete study questionnaires. After
      baseline measures are obtained, the study team will: 1) provide all participants with
      education about the CDC physical activity recommendations for adults, 2) set participants up
      with a wireless pedometer and 3) invite them to join a walking group on-line where they can
      monitor their activity as compared to others in the intervention arm. Members of the study
      team will then provide participants in the intervention arm with health coaching (HC)
      utilizing motivational interviewing (MI) weekly for 8 weeks by email, text message or
      telephone. The mode of delivery for the MI will be based on participant preference. The
      control group will be able to view the web page and monitor their activity compared to others
      in the control group arm, but will receive no coaching." At the end of the 8 weeks, study
      measures will be again be obtained in both groups. The PI will conduct semi-structured
      qualitative interviews with participants in the intervention arm to evaluate acceptability
      and acquire feedback on the intervention and ideas for other self-care strategies." Caregiver
      Measures Pre - Post

        1. Demographic variables

        2. General health characteristics

        3. Well-being

        4. Perceived stress

        5. Mini-cog

        6. Perceived Steps And post, a qualitative interview
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Convenience sample, randomized, intervention, pre-post design
primary purpose: Supportive Care
masking: Single (Participant)
masking description: Participants were randomly assigned through a toss of a coin to either the intervention or control
measure: Blood pressure
time frame: 8 weeks
description: systolic/diastolic
measure: Pulse rate will be combined to report BMI in kg/m^2BMI
time frame: 8 weeks
description: count of pulse rate for one minute
measure: height
time frame: 8 weeks
description: in meters
measure: weight
time frame: 8 weeks
description: in kg
measure: BMI
time frame: 8 weeks
description: weight and height will be combined to report BMI in kg/m^2
measure: wellbeing
time frame: 8 weeks
description: self report using 7 item Warwick wellbeing where 1 is none to 5 is all of the time (more positive reponse)
measure: Stress level
time frame: 8 weeks
description: self report using 10-item Perceived Stress Scale where 1 is no stress to 4 is highest level of stress
measure: Qualitative Descriptive
time frame: At end of 8 weeks
description: interviews
arm group label: Intervention
arm group type: Experimental
description: Will receive:
education
a wireless pedometer with set up
nurse coaching via text message, email or telephone based on participant preference and at frequency determined by the participant
arm group label: Control
arm group type: Experimental
description: Will receive:
education
a wireless pedometer with set up
intervention type: Behavioral
intervention name: Walking using a wireless pedometer
description: See arm/group
arm group label: Control
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jane Flanagan, PhD
role: Principal Investigator
affiliation: Boston College
facility: 
country: United States
url: https://academic.oup.com/innovateage/article/3/Supplement_1/S288/5615604
description: Geriatric Society of America Conference Proceedings
responsible party type: Sponsor
mesh term: Dementia
sharing ipd: Yes
ipd description: The Pi will make available upon request the study protocol, SAP, ICF and CSR and as possible these will be shared via dissemination of the findings.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: April 2020 - indefinitely
ipd access criteria: notify PI
ipd url: http://www.bc.edu/bc-web/schools/cson/faculty-research/faculty-directory/jane-m--flanagan.html