xml: <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/NCT05998343</url>
    </required_header>
    <id_info>
      <org_study_id>21-0074-E</org_study_id>
      <nct_id>NCT05998343</nct_id>
    </id_info>
    <brief_title>Intergenerational Program for Social Isolation and Loneliness in Older Adults Discharged From the Emergency Department</brief_title>
    <acronym>SIL</acronym>
    <official_title>Improving Social Isolation and Loneliness in Older Adults Discharged From the Emergency Department - Comparing an Intergenerational Versus Same Generation Peer-support Intervention Versus Common Wait List Control Group in a Three Arm RCT</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mount Sinai Hospital, Canada</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>North York General Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Sunnybrook Research Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Toronto</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Bolton Clarke Research Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>King's College London</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Mount Sinai Hospital, Canada</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Social isolation and loneliness worsens older adults' risk of dementia, quality of life, and&#xD;
        death as much as smoking. Older adults are more likely to use emergency services and are also&#xD;
        more likely to experience social isolation and loneliness than younger people. The emergency&#xD;
        department is a new setting to screen for social isolation and loneliness in older adults and&#xD;
        help accordingly.&#xD;
  &#xD;
        Social isolation and loneliness are experienced differently by different older adults.&#xD;
        Different interventions combatting social isolation and loneliness may work better for&#xD;
        different people, and little is known about older adult's preferences for specific types of&#xD;
        interventions.&#xD;
  &#xD;
        HOW R U? is an effective and feasible intervention using same-generation peer support offered&#xD;
        by trained hospital volunteers to reduce social isolation and loneliness in older adults. In&#xD;
        partnership with the Australian developer of HOW R U?, this study will compare an&#xD;
        intergenerational HOW R U? intervention using younger volunteers with the same-generation&#xD;
        peer support intervention and a waitlist control arm.&#xD;
  &#xD;
        The investigators partnered with the staff of emergency departments and family medicine&#xD;
        clinics to identify people who will benefit from an intervention combatting, and Volunteer&#xD;
        Services to recruit volunteers.&#xD;
  &#xD;
        The investigators hypothesize that the older adults who receive the intergenerational HOW R&#xD;
        U? intervention will have a greater improvement in social isolation and loneliness.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Introduction:&#xD;
  &#xD;
        Social isolation and loneliness (SIL) worsens mortality and other outcomes among older adults&#xD;
        as much as smoking. The investigators previously tested the impact of the HOW R U?&#xD;
        intervention using peer support from similar aged volunteers and demonstrated reduced SIL&#xD;
        among older adults discharged from the Emergency Department (ED). Generativity, defined as&#xD;
        &quot;the interest in establishing and guiding the next generation&quot; can provide an alternative&#xD;
        theoretical basis for reducing SIL via intergenerational programs between members of younger&#xD;
        and older generations. The current study will examine the impact of younger intergenerational&#xD;
        volunteers providing the HOW R U? intervention. As part of a program of research following&#xD;
        the Obesity-Related Behavioral Intervention Trials (ORBIT ) model, findings of this RCT will&#xD;
        be used to define which intervention characteristics are most effective in reducing SIL. This&#xD;
        trial builds on feasibility work conducted in the investigators' previous trial (NCT&#xD;
        05228782).&#xD;
  &#xD;
        Methods and Analysis:&#xD;
  &#xD;
        The investigators will compare the use of the same-generation peer support HOW RU?&#xD;
        intervention to support by intergenerational volunteers. The investigators will use a common&#xD;
        wait list control group in this three-arm randomized controlled trial (RCT).&#xD;
  &#xD;
        Trained volunteers will deliver 12 weekly telephone support calls. The investigators will&#xD;
        recruit 141 participants ≥70 years of age with baseline loneliness (six-item De Jong&#xD;
        loneliness score of 2 or greater) from two EDs. Research staff will assess change in&#xD;
        loneliness (De Jong Loneliness Scale), social isolation (Lubben's Social Network Scale),&#xD;
        depression (Geriatric Depression Score), quality of life (EQ-5D-5L), functional status (Older&#xD;
        Americans Resource Scale), generativity (Loyola Generativity Scale), and perceived benefit at&#xD;
        baseline (subjective Likert scale), at 12-14 weeks, and 24-26 weeks post-intervention. The&#xD;
        study will follow the Standard Protocol Items: Recommendations for Interventional Trials&#xD;
        (SPIRIT) guidelines.&#xD;
  &#xD;
        Ethics and Dissemination:&#xD;
  &#xD;
        The participating research ethics boards have granted ethics approval, and the participants&#xD;
        randomized to the waitlist control group will be offered their choice of intergenerational or&#xD;
        same-generation HOW R U? interventions after 12 weeks. Results will be shared through journal&#xD;
        publications, conference presentations, social media, and through the International&#xD;
        Federation of Emergency Medicine.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 1, 2021</start_date>
    <completion_date type="Anticipated">February 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2023</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>
      <intervention_model_description>This study is a three-arm outcome assessor blinded randomized controlled trial will follow SPIRIT reporting guidelines and is part of a program of research that adheres to the ORBIT model for developing complex behavioural interventions.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Primary outcomes will be assessed after 12 weeks by a research assistant who is blinded to the intervention group and who has had no prior contact with the participants. Participants will also be instructed not to reveal the intervention they have received to any research staff.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in loneliness using De Jong Gierveld 6-item Loneliness Scale from Baseline to 12 Weeks</measure>
      <time_frame>Measure at baseline, at 12 weeks (primary outcome) and 24 weeks (sustainability)</time_frame>
      <description>The minimum value is 0 and the maximum value is 6, with the higher value corresponding with a greater degree of loneliness. It is divided into 4 clinically relevant categories: 0-1 = no loneliness, 2-3 = low levels of loneliness, 4-5 = moderate to severe loneliness, and 6 = severe loneliness.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in perceived social support using Lubben Social Network Scale</measure>
      <time_frame>Measure at baseline, at 12 weeks and 24 weeks (sustainability)</time_frame>
      <description>The Lubben Social Network Scale is a measure of perceived social support received from the family and friends and consists of 6 items each of which is scored from 0 to 5: none = 0, one = 1, two = 2, three or four = 3, five through eight = 4, nine or more = 5. The total score ranges from 0 to 30, and a score of 12 and lower indicates a status of &quot;at-risk&quot; for social isolation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in mood using Geriatric Depression Scale</measure>
      <time_frame>Measure at baseline, at 12 weeks and 24 weeks (sustainability)</time_frame>
      <description>The Geriatric Depression Scale is a 15-item scale of mood that is extensively validated in older populations to screen for depression. Scores range from 0 to 15. A score of 0-4 is considered normal, and a score of 5 or higher is considered indicative of depression with higher scores indicating higher severity of depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Quality of Life using Euro-Qual 5 Dimensions 5 Levels</measure>
      <time_frame>Measure at baseline, at 12 weeks and 24 weeks (sustainability)</time_frame>
      <description>EQ-5D-5Lin 5 dimensions. In each dimension, quality of life can be measured from 1 (best quality of life) to 5 (worst quality of life), giving a possible score of 5-25. A higher score indicates worse quality of life. (Euro-Qual 5 Dimensions 5 Levels) scale assesses quality of life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Functional Status using Older Americans Resource Scale</measure>
      <time_frame>Measure at baseline, at 12 weeks and 24 weeks (sustainability)</time_frame>
      <description>The Older Americans Resource Scale (OARS) consists of 7 activities of daily living (ADL) questions and 7 instrumental activities of daily living (IADL) all rated as &quot;without any help&quot; (2 points), &quot;with some help&quot; (1 point), or &quot;completely unable&quot; (0 points). The ADL and IADL scores can be used separately or combined to produce an overall OARS score from 0-28.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in self-perceptions of generativity using Loyola Generativity Scale</measure>
      <time_frame>Measure at baseline, at 12 weeks and 24 weeks (sustainability)</time_frame>
      <description>The Loyola Generativity Scale is a 20-item scale with each question answered 0 = statement never applies to you, 1 = statement only occasionally or seldom applies to you, 2 = statement applies to you fairly often, or 3 = statement applies to you very often or nearly always.&#xD;
  The higher the score, the greater the sense of generativity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived benefit to participant at 12 weeks</measure>
      <time_frame>Measure at baseline, at 12 weeks and 24 weeks (sustainability)</time_frame>
      <description>Perceived benefit by the participant pre- and post-intervention will be assessed using the question &quot;Compared to working with a volunteer around the same age as you, you think that working with a younger volunteer is:&quot; followed by a 5-point Likert scale with the following options: A lot less helpful for me, a little less helpful for me, about the same for me, a little more helpful for me, or a lot more helpful for me.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived benefit to volunteer at 12 weeks</measure>
      <time_frame>Measure at baseline, at 12 weeks and 24 weeks (sustainability)</time_frame>
      <description>Perceived benefit by the participant for the volunteer pre- and post-intervention will be assessed using the question &quot;Compared to working with a volunteer around the same age as you, you think that working with a younger volunteer is:&quot; followed by a 5-point Likert scale with the following options: A lot less helpful for the volunteer, a little less helpful for the volunteer, about the same for the volunteer, a little more helpful for the volunteer, or a lot more helpful for volunteer.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Feasibility and Process Outcome 1 - Participant preference</measure>
      <time_frame>Measure at 12 weeks</time_frame>
      <description>To assess for participant preference for same-generation peer support versus intergenerational HOW R U? intervention, we will use a 5-point Likert scale with the following options: &quot;I strongly prefer peer support&quot;, &quot;I prefer peer support&quot;, &quot;neutral&quot;, &quot;I prefer intergenerational&quot; and &quot;I strongly prefer intergenerational&quot;.</description>
    </other_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">141</enrollment>
    <condition>Social Isolation</condition>
    <condition>Loneliness</condition>
    <condition>Geriatric</condition>
    <arm_group>
      <arm_group_label>HOW R U? intervention delivered by same-generation peer volunteer</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>HOW R U?</description>
    </arm_group>
    <arm_group>
      <arm_group_label>HOW R U? intervention delivered by intergenerational volunteer</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Waitlist control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>After the primary outcome assessment at 12 weeks, control group participants will be offered HOW R U? intervention support outside of the main trial. They will be allowed to choose either intergenerational or same-generation versions.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Intergenerational HOW R U?</intervention_name>
      <description>1-on-1 discussion over telephone with a trained volunteer aged 19-39 years old who has received training to provide strength-based support sessions weekly for 12 weeks.</description>
      <arm_group_label>HOW R U? intervention delivered by intergenerational volunteer</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Same-Generation Peer Support HOW R U?</intervention_name>
      <description>1-on-1 discussion over telephone with a trained volunteer aged 60 years or older who has received training to provide strength-based support sessions weekly for 12 weeks.</description>
      <arm_group_label>HOW R U? intervention delivered by same-generation peer volunteer</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Any community-dwelling person 70 years of age and older receiving care from the ED,&#xD;
               Family Medicine, or Geriatric clinics at the two participating sites (MSH and NYGH)&#xD;
               will be eligible.&#xD;
  &#xD;
            -  Baseline de Jong loneliness scores of 2.0 will be required for participation in the&#xD;
               trial.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age less than 70 years;&#xD;
  &#xD;
            -  Patients with communication problems (critically ill, unconscious, language barrier,&#xD;
               speech impairment or otherwise unable to provide consent), or admission to a hospital&#xD;
               for &gt; 72 hours.&#xD;
  &#xD;
            -  Patients with severe cognitive impairment or those living in nursing homes who are&#xD;
               dependent on others for their activity of daily living will be excluded.&#xD;
  &#xD;
            -  Patients without any mobile phone or landline.&#xD;
  &#xD;
          Volunteers:&#xD;
  &#xD;
            -  Volunteers will be 60 years of age or older to qualify as peer-support volunteers.&#xD;
  &#xD;
            -  Volunteers will be 19-39 years of age to qualify as intergenerational volunteers.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>70 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jacques Lee, MD</last_name>
      <phone>4168771447</phone>
      <email>Jacques.lee@sinaihealth.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>David Zheng, MD</last_name>
      <phone>5199335838</phone>
      <email>dzheng33@uwo.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Mount Sinai Hospital</name>
        <address>
          <city>Toronto</city>
          <state>Ontario</state>
          <zip>M5G 1XS</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jacques Lee, MD</last_name>
        <email>Jacques.lee@sinaihealth.ca</email>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Loneliness</keyword>
    <keyword>Social Isolation</keyword>
    <keyword>Emergency Department</keyword>
    <keyword>Geriatrics</keyword>
    <keyword>Geriatric Psychiatry</keyword>
    <keyword>Family Medicine</keyword>
    <keyword>Randomized Clinical Trial</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Emergencies</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The de-identified individual level data that support the findings of this study will be available on reasonable request from the Principal Investigator Dr. Jacques Lee (Jacques.lee@sinaihealth.ca) to improve scientific transparency, verify the study findings and generating new knowledge. As this research was supported by public funding, request for commercial purposes will require approval of the funding agency.</ipd_description>
      <ipd_time_frame>18 months from study completion</ipd_time_frame>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05998343
  org study id: 21-0074-E
  nct id: NCT05998343
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Social isolation and loneliness worsens older adults' risk of dementia, quality of life, and
        death as much as smoking. Older adults are more likely to use emergency services and are also
        more likely to experience social isolation and loneliness than younger people. The emergency
        department is a new setting to screen for social isolation and loneliness in older adults and
        help accordingly.
  
        Social isolation and loneliness are experienced differently by different older adults.
        Different interventions combatting social isolation and loneliness may work better for
        different people, and little is known about older adult's preferences for specific types of
        interventions.
  
        HOW R U? is an effective and feasible intervention using same-generation peer support offered
        by trained hospital volunteers to reduce social isolation and loneliness in older adults. In
        partnership with the Australian developer of HOW R U?, this study will compare an
        intergenerational HOW R U? intervention using younger volunteers with the same-generation
        peer support intervention and a waitlist control arm.
  
        The investigators partnered with the staff of emergency departments and family medicine
        clinics to identify people who will benefit from an intervention combatting, and Volunteer
        Services to recruit volunteers.
  
        The investigators hypothesize that the older adults who receive the intergenerational HOW R
        U? intervention will have a greater improvement in social isolation and loneliness.
  Introduction:
  
        Social isolation and loneliness (SIL) worsens mortality and other outcomes among older adults
        as much as smoking. The investigators previously tested the impact of the HOW R U?
        intervention using peer support from similar aged volunteers and demonstrated reduced SIL
        among older adults discharged from the Emergency Department (ED). Generativity, defined as
        "the interest in establishing and guiding the next generation" can provide an alternative
        theoretical basis for reducing SIL via intergenerational programs between members of younger
        and older generations. The current study will examine the impact of younger intergenerational
        volunteers providing the HOW R U? intervention. As part of a program of research following
        the Obesity-Related Behavioral Intervention Trials (ORBIT ) model, findings of this RCT will
        be used to define which intervention characteristics are most effective in reducing SIL. This
        trial builds on feasibility work conducted in the investigators' previous trial (NCT
        05228782).
  
        Methods and Analysis:
  
        The investigators will compare the use of the same-generation peer support HOW RU?
        intervention to support by intergenerational volunteers. The investigators will use a common
        wait list control group in this three-arm randomized controlled trial (RCT).
  
        Trained volunteers will deliver 12 weekly telephone support calls. The investigators will
        recruit 141 participants ≥70 years of age with baseline loneliness (six-item De Jong
        loneliness score of 2 or greater) from two EDs. Research staff will assess change in
        loneliness (De Jong Loneliness Scale), social isolation (Lubben's Social Network Scale),
        depression (Geriatric Depression Score), quality of life (EQ-5D-5L), functional status (Older
        Americans Resource Scale), generativity (Loyola Generativity Scale), and perceived benefit at
        baseline (subjective Likert scale), at 12-14 weeks, and 24-26 weeks post-intervention. The
        study will follow the Standard Protocol Items: Recommendations for Interventional Trials
        (SPIRIT) guidelines.
  
        Ethics and Dissemination:
  
        The participating research ethics boards have granted ethics approval, and the participants
        randomized to the waitlist control group will be offered their choice of intergenerational or
        same-generation HOW R U? interventions after 12 weeks. Results will be shared through journal
        publications, conference presentations, social media, and through the International
        Federation of Emergency Medicine.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This study is a three-arm outcome assessor blinded randomized controlled trial will follow SPIRIT reporting guidelines and is part of a program of research that adheres to the ORBIT model for developing complex behavioural interventions.
  primary purpose: Supportive Care
  masking: Single (Outcomes Assessor)
  masking description: Primary outcomes will be assessed after 12 weeks by a research assistant who is blinded to the intervention group and who has had no prior contact with the participants. Participants will also be instructed not to reveal the intervention they have received to any research staff.
  measure: Change in loneliness using De Jong Gierveld 6-item Loneliness Scale from Baseline to 12 Weeks
  time frame: Measure at baseline, at 12 weeks (primary outcome) and 24 weeks (sustainability)
  description: The minimum value is 0 and the maximum value is 6, with the higher value corresponding with a greater degree of loneliness. It is divided into 4 clinically relevant categories: 0-1 = no loneliness, 2-3 = low levels of loneliness, 4-5 = moderate to severe loneliness, and 6 = severe loneliness.
  measure: Change in perceived social support using Lubben Social Network Scale
  time frame: Measure at baseline, at 12 weeks and 24 weeks (sustainability)
  description: The Lubben Social Network Scale is a measure of perceived social support received from the family and friends and consists of 6 items each of which is scored from 0 to 5: none = 0, one = 1, two = 2, three or four = 3, five through eight = 4, nine or more = 5. The total score ranges from 0 to 30, and a score of 12 and lower indicates a status of "at-risk" for social isolation
  measure: Change in mood using Geriatric Depression Scale
  time frame: Measure at baseline, at 12 weeks and 24 weeks (sustainability)
  description: The Geriatric Depression Scale is a 15-item scale of mood that is extensively validated in older populations to screen for depression. Scores range from 0 to 15. A score of 0-4 is considered normal, and a score of 5 or higher is considered indicative of depression with higher scores indicating higher severity of depression.
  measure: Change in Quality of Life using Euro-Qual 5 Dimensions 5 Levels
  time frame: Measure at baseline, at 12 weeks and 24 weeks (sustainability)
  description: EQ-5D-5Lin 5 dimensions. In each dimension, quality of life can be measured from 1 (best quality of life) to 5 (worst quality of life), giving a possible score of 5-25. A higher score indicates worse quality of life. (Euro-Qual 5 Dimensions 5 Levels) scale assesses quality of life
  measure: Change in Functional Status using Older Americans Resource Scale
  time frame: Measure at baseline, at 12 weeks and 24 weeks (sustainability)
  description: The Older Americans Resource Scale (OARS) consists of 7 activities of daily living (ADL) questions and 7 instrumental activities of daily living (IADL) all rated as "without any help" (2 points), "with some help" (1 point), or "completely unable" (0 points). The ADL and IADL scores can be used separately or combined to produce an overall OARS score from 0-28.
  measure: Change in self-perceptions of generativity using Loyola Generativity Scale
  time frame: Measure at baseline, at 12 weeks and 24 weeks (sustainability)
  description: The Loyola Generativity Scale is a 20-item scale with each question answered 0 = statement never applies to you, 1 = statement only occasionally or seldom applies to you, 2 = statement applies to you fairly often, or 3 = statement applies to you very often or nearly always.
  The higher the score, the greater the sense of generativity.
  measure: Perceived benefit to participant at 12 weeks
  time frame: Measure at baseline, at 12 weeks and 24 weeks (sustainability)
  description: Perceived benefit by the participant pre- and post-intervention will be assessed using the question "Compared to working with a volunteer around the same age as you, you think that working with a younger volunteer is:" followed by a 5-point Likert scale with the following options: A lot less helpful for me, a little less helpful for me, about the same for me, a little more helpful for me, or a lot more helpful for me.
  measure: Perceived benefit to volunteer at 12 weeks
  time frame: Measure at baseline, at 12 weeks and 24 weeks (sustainability)
  description: Perceived benefit by the participant for the volunteer pre- and post-intervention will be assessed using the question "Compared to working with a volunteer around the same age as you, you think that working with a younger volunteer is:" followed by a 5-point Likert scale with the following options: A lot less helpful for the volunteer, a little less helpful for the volunteer, about the same for the volunteer, a little more helpful for the volunteer, or a lot more helpful for volunteer.
  measure: Feasibility and Process Outcome 1 - Participant preference
  time frame: Measure at 12 weeks
  description: To assess for participant preference for same-generation peer support versus intergenerational HOW R U? intervention, we will use a 5-point Likert scale with the following options: "I strongly prefer peer support", "I prefer peer support", "neutral", "I prefer intergenerational" and "I strongly prefer intergenerational".
  arm group label: HOW R U? intervention delivered by same-generation peer volunteer
  arm group type: Experimental
  description: HOW R U?
  arm group label: HOW R U? intervention delivered by intergenerational volunteer
  arm group type: Experimental
  arm group label: Waitlist control group
  arm group type: No Intervention
  description: After the primary outcome assessment at 12 weeks, control group participants will be offered HOW R U? intervention support outside of the main trial. They will be allowed to choose either intergenerational or same-generation versions.
  intervention type: Behavioral
  intervention name: Intergenerational HOW R U?
  description: 1-on-1 discussion over telephone with a trained volunteer aged 19-39 years old who has received training to provide strength-based support sessions weekly for 12 weeks.
  arm group label: HOW R U? intervention delivered by intergenerational volunteer
  intervention type: Behavioral
  intervention name: Same-Generation Peer Support HOW R U?
  description: 1-on-1 discussion over telephone with a trained volunteer aged 60 years or older who has received training to provide strength-based support sessions weekly for 12 weeks.
  arm group label: HOW R U? intervention delivered by same-generation peer volunteer
  criteria: 
  gender: All
  minimum age: 70 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jacques Lee, MD
  phone: 4168771447
  email: Jacques.lee@sinaihealth.ca
  last name: David Zheng, MD
  phone: 5199335838
  email: dzheng33@uwo.ca
  facility: 
  status: Recruiting
  contact: 
  country: Canada
  responsible party type: Sponsor
  mesh term: Emergencies
  sharing ipd: Yes
  ipd description: The de-identified individual level data that support the findings of this study will be available on reasonable request from the Principal Investigator Dr. Jacques Lee (Jacques.lee@sinaihealth.ca) to improve scientific transparency, verify the study findings and generating new knowledge. As this research was supported by public funding, request for commercial purposes will require approval of the funding agency.
  ipd time frame: 18 months from study completion