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/NCT05977608</url>
    </required_header>
    <id_info>
      <org_study_id>H23-0046</org_study_id>
      <nct_id>NCT05977608</nct_id>
    </id_info>
    <brief_title>The Impact of a Telephone Reminiscence Program</brief_title>
    <official_title>The Impact of a Telephone Reminiscence Program on Reminiscence Functions and Mental Health Outcomes in Community-Dwelling Older Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Connecticut</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>StoriiCare Company</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Connecticut</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 purpose of this study is to better understand how a telephone reminiscence program&#xD;
        impacts reminiscence functions and mental health outcomes in community-dwelling older&#xD;
        adults.This study will take 12 weeks to complete and will include approximately 90 study&#xD;
        participants. Participants will be randomly assigned to one of two telephone reminiscence&#xD;
        groups.They will be either assigned to begin a telephone reminiscence program immediately or&#xD;
        in 6 weeks. Participants will receive automatic calls three times a week asking the&#xD;
        meaningful questions about their lives. At week 1, week 6, and week 12, participants will&#xD;
        also be asked to complete assessments via phone, by research assistants using four&#xD;
        questionnaires.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The prevalence of social isolation and loneliness among older adults is a public health&#xD;
        problem. It is reported that 25 % of community-dwelling older adults 65 and older are&#xD;
        socially isolated while 43 % of older adults 60 and older feel lonely (Cudge et al., 2020).&#xD;
        Research has shown that social isolation and loneliness are associated with cardiovascular&#xD;
        disease, stroke, depression, dementia, and mortality (Holjlerda, 2016). Loneliness, in&#xD;
        particular, has been identified as a potential predictor of mild cognitive impairment (Bundy,&#xD;
        et al., 2021; Sutin et al., 2018; Dahlberg, 2021). As a result of the prevalence data,&#xD;
        gerontologists and researchers have cited the need for developing, implementing and testing&#xD;
        innovative interventions to address this problem. Reminiscence is one example of a&#xD;
        cost-effective intervention shown to decrease loneliness and improve mental health and&#xD;
        wellness.&#xD;
  &#xD;
        STORII is a telephone reminiscence program designed to provide a service that automatically&#xD;
        calls older adults three times a week asking them meaningful questions about their lives. The&#xD;
        participants have the opportunity to select curated prompts that enable them to record their&#xD;
        life stories through the phone. The participants can choose to share them online with their&#xD;
        families. Through formative evaluation of the program, the STORII team has noted that their&#xD;
        participants to be highly satisfied and highly engaged. As a result of these informal data,&#xD;
        it was decided that a more in-depth investigation should be undertaken. Therefore, the&#xD;
        purpose of this study is to examine the impact of the STORII program on reminiscence&#xD;
        functions and mental health outcomes in community-dwelling older adults.&#xD;
  &#xD;
        Participants will be invited to join a telephone reminiscence program designed to provide a&#xD;
        service that automatically calls older adults three times a week asking them meaningful&#xD;
        questions about their lives. Examples of the questions are &quot;What is the best meal you have&#xD;
        ever tasted?&quot;, &quot;What is one of your proudest moments?&quot;, &quot;What is your earliest memory?&quot;.&#xD;
        Participants can share as much or as little as they would like. They have up to 10 minutes to&#xD;
        record the answers and can end the call at any time by hanging up. There will be no operator&#xD;
        on the line that can hear or respond. The participants can choose to share their stories&#xD;
        online with their families.&#xD;
  &#xD;
        All outcome measures will be assessed at baseline (T0), 6-week post-test (T1), and at 12-week&#xD;
        follow-up (T2). Participants will complete assessments via phone, by trained research&#xD;
        assistants using four questionnaires. Assessments will be completed by research assistants&#xD;
        who are not aware of participants' allocation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 25, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 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>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Mental health as measured by mean changes in the Mental Health Continuum Short Form (MHC-SF) scores</measure>
      <time_frame>Baseline, Week 6 (Endpoint), Week 12 (Follow up)</time_frame>
      <description>The Mental Health Continuum Short Form (MHC-SF) (Keyes, 2002) will be used to assess mental health and well-being. The 14 item scale measures emotional, social, and psychological dimensions of mental health. Participants answer each item on a 6-point scale, ranging from 0 and 5, resulting in a total score between 0 to 70. The emotional well-being subscale has a range from 0 to 15, the social well-being subscale scores range from 0 to 25, and the psychological well-being subscale scores range from 0 to 30. Higher scores on MHC- SF indicate a higher level of mental well-being. The MHC-SF has demonstrated excellent internal consistency (&gt;.80) and discriminant validity in adults in the United States (Keyes, 2005, 2006), and its test-retest reliability has also been demonstrated, with an average of 0.68 over three consecutive three-month periods and 0.65 over a 9-month period (Lamers et al., 2011).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in reminiscence functions as measured by mean changes in the Modified Reminiscence Functions Scale (MRFS) scores</measure>
      <time_frame>Baseline, Week 6 (Endpoint), Week 12 (Follow up)</time_frame>
      <description>The Modified Reminiscence Functions Scale (MRFS) containing 29 items will be used to measure reminiscence functions. The scale measures the frequency of different reminiscence functions identified as: (a) self-regard, (b) death preparation, (c) bitterness revival, (d) conversation, and (e) intimacy maintenance, teach and inform, boredom reduction, and conversation. Respondents are asked to report their level of agreement with statements such as, &quot;When I reminisce, it is to teach younger people about cultural values&quot; or &quot;When I reminisce, recalling my past help me know who I am now&quot; on a 5-point scale ranging from 1 (never) to 5 (very often). A higher score indicates more frequent reminiscences for the specific function. The Cronbach's Alpha for the subscales ranged from .73 to .91, indicating good internal consistency (Shellman &amp; Zhang, 2014; Washington, 2009).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from loneliness as measured by mean changes in UCLA 3 Item Loneliness Scale scores</measure>
      <time_frame>Baseline, Week 6 (Endpoint), Week 12 (Follow up)</time_frame>
      <description>UCLA 3 Item Loneliness Scale (UCLA 3) (Russell, 1996) is a brief 3-item scale that measures three dimensions of loneliness: relational connectedness, social connectedness, and self. Responses are provided on a 3-point response scale ranging from &quot;hardly&quot; to &quot;often&quot;, with total scores ranging from 3 to 9. Higher scores indicate a higher level of loneliness. The instrument has favorable psychometric properties, including high internal consistency (ranging from 0.89 to 0.94) and a good test-retest reliability over one year (r = .73) (Russell, 1996).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from life satisfaction as measured by mean changes in the Satisfaction with Life Scale scores</measure>
      <time_frame>Baseline, Week 6 (Endpoint), Week 12 (Follow up)</time_frame>
      <description>The Satisfaction with Life Scale (SWLS) (Diener et al., 1985) is a measure of life satisfaction that includes five statements, such as &quot;In most ways, my life is close to my ideal.&quot; Responses are provided on a seven-point scale ranging from (1) &quot;strongly disagree&quot; to (7) &quot;strongly agree&quot;, with a total score ranging from 7 to 35. Higher scores indicate greater life satisfaction. The scale is a highly reliable measure, with good internal consistency (0.87) and high test-retest reliability over a 2-month period (r = .82) (Diener et al., 1985).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Mental Health</condition>
    <condition>Loneliness</condition>
    <condition>Social Isolation</condition>
    <arm_group>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be asked to participate in the reminiscence program during the first 6 weeks of the study.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be asked to participate in the reminiscence program during the second 6 weeks of the study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Telephone Reminiscence Intervention</intervention_name>
      <description>Participants will receive automatic calls three times a week asking their life experiences and personal memories. They can share as much or as little as they would like. They have up to 10 minutes to record their answer and can end the call at any time by hanging up.They will be able to share the stories online with their families if they want.</description>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_label>Group 2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults age &gt;60 years;&#xD;
  &#xD;
            -  English speaking&#xD;
  &#xD;
            -  Community-dwelling&#xD;
  &#xD;
            -  Willing to participate in a 12 week study&#xD;
  &#xD;
            -  Willing and able to share memories using a telephone, 10 minutes, 3 times a week&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Significant hearing loss&#xD;
  &#xD;
            -  Cognitive impairment&#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_contact>
      <last_name>Juliette Shellman, PhD</last_name>
      <phone>860-212-4044</phone>
      <email>juliette.shellman@uconn.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Connecticut</name>
        <address>
          <city>Storrs</city>
          <state>Connecticut</state>
          <zip>06269</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Juliette Shellman, PhD</last_name>
        <phone>860-212-4044</phone>
        <email>juliette.shellman@uconn.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Keyes CL. The mental health continuum: from languishing to flourishing in life. J Health Soc Behav. 2002 Jun;43(2):207-22.</citation>
      <PMID>12096700</PMID>
    </reference>
    <reference>
      <citation>Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.</citation>
      <PMID>16367493</PMID>
    </reference>
    <reference>
      <citation>Russell DW. UCLA Loneliness Scale (Version 3): reliability, validity, and factor structure. J Pers Assess. 1996 Feb;66(1):20-40. doi: 10.1207/s15327752jpa6601_2.</citation>
      <PMID>8576833</PMID>
    </reference>
    <reference>
      <citation>Shellman JM, Zhang D. Psychometric testing of the Modified Reminiscence Functions Scale. J Nurs Meas. 2014;22(3):500-10. doi: 10.1891/1061-3749.22.3.500.</citation>
      <PMID>25608435</PMID>
    </reference>
    <reference>
      <citation>Cudjoe TKM, Roth DL, Szanton SL, Wolff JL, Boyd CM, Thorpe RJ. The Epidemiology of Social Isolation: National Health and Aging Trends Study. J Gerontol B Psychol Sci Soc Sci. 2020 Jan 1;75(1):107-113. doi: 10.1093/geronb/gby037.</citation>
      <PMID>29590462</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Connecticut</investigator_affiliation>
      <investigator_full_name>Juliette Shellman</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05977608
  org study id: H23-0046
  nct id: NCT05977608
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to better understand how a telephone reminiscence program
        impacts reminiscence functions and mental health outcomes in community-dwelling older
        adults.This study will take 12 weeks to complete and will include approximately 90 study
        participants. Participants will be randomly assigned to one of two telephone reminiscence
        groups.They will be either assigned to begin a telephone reminiscence program immediately or
        in 6 weeks. Participants will receive automatic calls three times a week asking the
        meaningful questions about their lives. At week 1, week 6, and week 12, participants will
        also be asked to complete assessments via phone, by research assistants using four
        questionnaires.
  The prevalence of social isolation and loneliness among older adults is a public health
        problem. It is reported that 25 % of community-dwelling older adults 65 and older are
        socially isolated while 43 % of older adults 60 and older feel lonely (Cudge et al., 2020).
        Research has shown that social isolation and loneliness are associated with cardiovascular
        disease, stroke, depression, dementia, and mortality (Holjlerda, 2016). Loneliness, in
        particular, has been identified as a potential predictor of mild cognitive impairment (Bundy,
        et al., 2021; Sutin et al., 2018; Dahlberg, 2021). As a result of the prevalence data,
        gerontologists and researchers have cited the need for developing, implementing and testing
        innovative interventions to address this problem. Reminiscence is one example of a
        cost-effective intervention shown to decrease loneliness and improve mental health and
        wellness.
  
        STORII is a telephone reminiscence program designed to provide a service that automatically
        calls older adults three times a week asking them meaningful questions about their lives. The
        participants have the opportunity to select curated prompts that enable them to record their
        life stories through the phone. The participants can choose to share them online with their
        families. Through formative evaluation of the program, the STORII team has noted that their
        participants to be highly satisfied and highly engaged. As a result of these informal data,
        it was decided that a more in-depth investigation should be undertaken. Therefore, the
        purpose of this study is to examine the impact of the STORII program on reminiscence
        functions and mental health outcomes in community-dwelling older adults.
  
        Participants will be invited to join a telephone reminiscence program designed to provide a
        service that automatically calls older adults three times a week asking them meaningful
        questions about their lives. Examples of the questions are "What is the best meal you have
        ever tasted?", "What is one of your proudest moments?", "What is your earliest memory?".
        Participants can share as much or as little as they would like. They have up to 10 minutes to
        record the answers and can end the call at any time by hanging up. There will be no operator
        on the line that can hear or respond. The participants can choose to share their stories
        online with their families.
  
        All outcome measures will be assessed at baseline (T0), 6-week post-test (T1), and at 12-week
        follow-up (T2). Participants will complete assessments via phone, by trained research
        assistants using four questionnaires. Assessments will be completed by research assistants
        who are not aware of participants' allocation.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Double (Participant, Outcomes Assessor)
  measure: Change in Mental health as measured by mean changes in the Mental Health Continuum Short Form (MHC-SF) scores
  time frame: Baseline, Week 6 (Endpoint), Week 12 (Follow up)
  description: The Mental Health Continuum Short Form (MHC-SF) (Keyes, 2002) will be used to assess mental health and well-being. The 14 item scale measures emotional, social, and psychological dimensions of mental health. Participants answer each item on a 6-point scale, ranging from 0 and 5, resulting in a total score between 0 to 70. The emotional well-being subscale has a range from 0 to 15, the social well-being subscale scores range from 0 to 25, and the psychological well-being subscale scores range from 0 to 30. Higher scores on MHC- SF indicate a higher level of mental well-being. The MHC-SF has demonstrated excellent internal consistency (>.80) and discriminant validity in adults in the United States (Keyes, 2005, 2006), and its test-retest reliability has also been demonstrated, with an average of 0.68 over three consecutive three-month periods and 0.65 over a 9-month period (Lamers et al., 2011).
  measure: Change in reminiscence functions as measured by mean changes in the Modified Reminiscence Functions Scale (MRFS) scores
  time frame: Baseline, Week 6 (Endpoint), Week 12 (Follow up)
  description: The Modified Reminiscence Functions Scale (MRFS) containing 29 items will be used to measure reminiscence functions. The scale measures the frequency of different reminiscence functions identified as: (a) self-regard, (b) death preparation, (c) bitterness revival, (d) conversation, and (e) intimacy maintenance, teach and inform, boredom reduction, and conversation. Respondents are asked to report their level of agreement with statements such as, "When I reminisce, it is to teach younger people about cultural values" or "When I reminisce, recalling my past help me know who I am now" on a 5-point scale ranging from 1 (never) to 5 (very often). A higher score indicates more frequent reminiscences for the specific function. The Cronbach's Alpha for the subscales ranged from .73 to .91, indicating good internal consistency (Shellman & Zhang, 2014; Washington, 2009).
  measure: Change from loneliness as measured by mean changes in UCLA 3 Item Loneliness Scale scores
  time frame: Baseline, Week 6 (Endpoint), Week 12 (Follow up)
  description: UCLA 3 Item Loneliness Scale (UCLA 3) (Russell, 1996) is a brief 3-item scale that measures three dimensions of loneliness: relational connectedness, social connectedness, and self. Responses are provided on a 3-point response scale ranging from "hardly" to "often", with total scores ranging from 3 to 9. Higher scores indicate a higher level of loneliness. The instrument has favorable psychometric properties, including high internal consistency (ranging from 0.89 to 0.94) and a good test-retest reliability over one year (r = .73) (Russell, 1996).
  measure: Change from life satisfaction as measured by mean changes in the Satisfaction with Life Scale scores
  time frame: Baseline, Week 6 (Endpoint), Week 12 (Follow up)
  description: The Satisfaction with Life Scale (SWLS) (Diener et al., 1985) is a measure of life satisfaction that includes five statements, such as "In most ways, my life is close to my ideal." Responses are provided on a seven-point scale ranging from (1) "strongly disagree" to (7) "strongly agree", with a total score ranging from 7 to 35. Higher scores indicate greater life satisfaction. The scale is a highly reliable measure, with good internal consistency (0.87) and high test-retest reliability over a 2-month period (r = .82) (Diener et al., 1985).
  arm group label: Group 1
  arm group type: Experimental
  description: Participants will be asked to participate in the reminiscence program during the first 6 weeks of the study.
  arm group label: Group 2
  arm group type: Experimental
  description: Participants will be asked to participate in the reminiscence program during the second 6 weeks of the study.
  intervention type: Behavioral
  intervention name: Telephone Reminiscence Intervention
  description: Participants will receive automatic calls three times a week asking their life experiences and personal memories. They can share as much or as little as they would like. They have up to 10 minutes to record their answer and can end the call at any time by hanging up.They will be able to share the stories online with their families if they want.
  arm group label: Group 1
  arm group label: Group 2
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Juliette Shellman, PhD
  phone: 860-212-4044
  email: juliette.shellman@uconn.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  citation: Keyes CL. The mental health continuum: from languishing to flourishing in life. J Health Soc Behav. 2002 Jun;43(2):207-22.
  PMID: 12096700
  citation: Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
  PMID: 16367493
  citation: Russell DW. UCLA Loneliness Scale (Version 3): reliability, validity, and factor structure. J Pers Assess. 1996 Feb;66(1):20-40. doi: 10.1207/s15327752jpa6601_2.
  PMID: 8576833
  citation: Shellman JM, Zhang D. Psychometric testing of the Modified Reminiscence Functions Scale. J Nurs Meas. 2014;22(3):500-10. doi: 10.1891/1061-3749.22.3.500.
  PMID: 25608435
  citation: Cudjoe TKM, Roth DL, Szanton SL, Wolff JL, Boyd CM, Thorpe RJ. The Epidemiology of Social Isolation: National Health and Aging Trends Study. J Gerontol B Psychol Sci Soc Sci. 2020 Jan 1;75(1):107-113. doi: 10.1093/geronb/gby037.
  PMID: 29590462
  responsible party type: Principal Investigator
  investigator affiliation: University of Connecticut
  investigator full name: Juliette Shellman
  investigator title: Associate Professor
  sharing ipd: No