<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/NCT03252262</url>
  </required_header>
  <id_info>
    <org_study_id>P 30 AG048785</org_study_id>
    <nct_id>NCT03252262</nct_id>
  </id_info>
  <brief_title>Power V360 - Promoting Optimal Wellness Among Elders Through Vitalize 360</brief_title>
  <official_title>Power V360 - Promoting Optimal Wellness Among Elders Through Vitalize 360</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hebrew SeniorLife</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hebrew SeniorLife</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 primary purpose of this project was to implement Vitalize 360, a comprehensive assessment&#xD;
      system and wellness coaching program for vulnerable, low income, community dwelling older&#xD;
      adults, and to determine if this program is effective in promoting and sustaining&#xD;
      self-management skills to increase well-being and functional health among this group.&#xD;
      Designed specifically for community-dwelling older adults, Vitalize 360 provides a unique&#xD;
      opportunity to guide elders in selecting personal goals that align with their assessment&#xD;
      results and develop an action plan for goal achievement. This strategy holds potential as an&#xD;
      effective mechanism to empower elders to implement behaviors that promote healthy aging.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this project was to determine if Vitalize 360, a comprehensive assessment&#xD;
      system and wellness coaching program was effective in promoting and sustaining increased&#xD;
      physical activity and improved mood, health status and quality of life. A repeated measures,&#xD;
      secondary analysis design was the selected approach Data from 161 participants were used to&#xD;
      test the hypotheses. After one year, the sample had improvement with increased socialization&#xD;
      while physical activity level fluctuated over time suggestive of a seasonality effect. Paired&#xD;
      t-tests and repeated measures analysis revealed no statistically significant improvement in&#xD;
      physical activity level, mood, health status or quality of life. Vitalize 360 provides a&#xD;
      unique opportunity to guide elders in selecting personal goals that align with their&#xD;
      assessment results and develop an action plan for goal achievement. When used among&#xD;
      vulnerable and frail elders, some modifications are needed to provide sustained, favorable&#xD;
      outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2014</start_date>
  <completion_date type="Actual">December 30, 2015</completion_date>
  <primary_completion_date type="Actual">December 30, 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Physical Activity Level</measure>
    <time_frame>18 months</time_frame>
    <description>number of hours engaged in physical activity over the past 3 days</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">161</enrollment>
  <condition>Health, Subjective</condition>
  <arm_group>
    <arm_group_label>Jack Satter House</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Residents of Jack Satter House who participated in the Vitalize 360 Program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Center Communities of Brookline</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Residents of Center Communities of Brookline who participated in the Vitalize 360 Program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Simon C. Fireman</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Residents of Simon C. Fireman who participated in the Vitalize 360 Program</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vitalize 360</intervention_name>
    <description>A comprehensive geriatric assessment system and wellness coaching program.</description>
    <arm_group_label>Center Communities of Brookline</arm_group_label>
    <arm_group_label>Jack Satter House</arm_group_label>
    <arm_group_label>Simon C. Fireman</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Age 60 years and over, residing in subsidized housing sites operated by Hebrew SeniorLife&#xD;
        and participating in Vitalize 360 program&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        younger than 60 years, not participating in Vitalize 360 program and not a permanent&#xD;
        resident of housing sites.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elizabeth P Howard, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hebrew Rehabilitation Center</affiliation>
  </overall_official>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>April 12, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 14, 2017</last_update_submitted>
  <last_update_submitted_qc>August 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Contact PI to obtain approval for use of COLLAGE/interRAI data</ipd_description>
  </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/NCT03252262
org study id: P 30 AG048785
nct id: NCT03252262
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary purpose of this project was to implement Vitalize 360, a comprehensive assessment
      system and wellness coaching program for vulnerable, low income, community dwelling older
      adults, and to determine if this program is effective in promoting and sustaining
      self-management skills to increase well-being and functional health among this group.
      Designed specifically for community-dwelling older adults, Vitalize 360 provides a unique
      opportunity to guide elders in selecting personal goals that align with their assessment
      results and develop an action plan for goal achievement. This strategy holds potential as an
      effective mechanism to empower elders to implement behaviors that promote healthy aging.
The purpose of this project was to determine if Vitalize 360, a comprehensive assessment
      system and wellness coaching program was effective in promoting and sustaining increased
      physical activity and improved mood, health status and quality of life. A repeated measures,
      secondary analysis design was the selected approach Data from 161 participants were used to
      test the hypotheses. After one year, the sample had improvement with increased socialization
      while physical activity level fluctuated over time suggestive of a seasonality effect. Paired
      t-tests and repeated measures analysis revealed no statistically significant improvement in
      physical activity level, mood, health status or quality of life. Vitalize 360 provides a
      unique opportunity to guide elders in selecting personal goals that align with their
      assessment results and develop an action plan for goal achievement. When used among
      vulnerable and frail elders, some modifications are needed to provide sustained, favorable
      outcomes.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Physical Activity Level
time frame: 18 months
description: number of hours engaged in physical activity over the past 3 days
arm group label: Jack Satter House
arm group type: Active Comparator
description: Residents of Jack Satter House who participated in the Vitalize 360 Program.
arm group label: Center Communities of Brookline
arm group type: Active Comparator
description: Residents of Center Communities of Brookline who participated in the Vitalize 360 Program.
arm group label: Simon C. Fireman
arm group type: Active Comparator
description: Residents of Simon C. Fireman who participated in the Vitalize 360 Program
intervention type: Other
intervention name: Vitalize 360
description: A comprehensive geriatric assessment system and wellness coaching program.
arm group label: Center Communities of Brookline
arm group label: Jack Satter House
arm group label: Simon C. Fireman
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Elizabeth P Howard, PhD
role: Principal Investigator
affiliation: Hebrew Rehabilitation Center
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Contact PI to obtain approval for use of COLLAGE/interRAI data