<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/NCT03009851</url>
  </required_header>
  <id_info>
    <org_study_id>RRF 2014-090</org_study_id>
    <nct_id>NCT03009851</nct_id>
  </id_info>
  <brief_title>Testing the Effectiveness of an Occupation-based Cultural Intervention in Long-term Care</brief_title>
  <acronym>OBCHI</acronym>
  <official_title>Testing an Occupation-Based Cultural Heritage Intervention in Long-Term Care Facilities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Texas Woman's University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Retirement Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Texas Woman's University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goals of the proposed research were to:&#xD;
&#xD;
        1. describe the person and environment characteristics and activity patterns of residents&#xD;
           in long-term care (LTC) facilities;&#xD;
&#xD;
        2. modify the evidence-based, occupation-based cultural heritage intervention (OBCHI)&#xD;
           grounded on the results of Aim 1;&#xD;
&#xD;
        3. test the effectiveness of the OBCHI intended to facilitate adaptation to relocation into&#xD;
           LTC facilities relative to a usual activities group;&#xD;
&#xD;
        4. determine the cost-effectiveness of the intervention conducted by in-house staff&#xD;
           compared to the control group; and&#xD;
&#xD;
        5. examine person and environment factors as potential moderators of the relationship&#xD;
           between treatment condition and adaptation outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specific Aims&#xD;
&#xD;
      Primary Aims&#xD;
&#xD;
        1. Describe the person and environment characteristics and activity patterns of residents&#xD;
           in LTC facilities.&#xD;
&#xD;
        2. Modify the OBCHI grounded on the evidence-based results of Aim 1 specific to these&#xD;
           facilities and residents.&#xD;
&#xD;
        3. Test the effectiveness of the OBCHI conducted by activity department staff, relative to&#xD;
           usual activities, as measured by quality of life, activity engagement, and social&#xD;
           participation.&#xD;
&#xD;
           H1a-c: Those receiving OBCHI will have significantly greater improvement in&#xD;
&#xD;
           a) quality of life, b) activity engagement, and c) social participation at&#xD;
           post-intervention relative to those receiving usual activities.&#xD;
&#xD;
           H2a-c: Those receiving OBCHI will have greater maintenance of improvements in a) quality&#xD;
           of life, b) activity engagement, and c) social participation at 1-month follow-up,&#xD;
           relative to those receiving usual activities.&#xD;
&#xD;
        4. Determine the cost-effectiveness of the intervention in terms of quality adjusted life&#xD;
           year (QALY) and other health factors.&#xD;
&#xD;
           H3: When OBCHI is proven to be more effective in promoting quality of life than usual&#xD;
           activities, the investigators will expect the OBCHI to produce a higher QALY at a lower&#xD;
           cost per QALY.&#xD;
&#xD;
           H4: Between these two mutually exclusive treatments, the OBCHI intervention will be more&#xD;
           efficient (more effective and less costly) or cost saving with a negative incremental&#xD;
           cost-effectiveness ratio (ICER) when compared to those receiving usual activities.&#xD;
&#xD;
           Exploratory Aim&#xD;
&#xD;
        5. Examine person characteristics (i.e. cultural heritage, life experiences social support,&#xD;
           resilience, depression, and resident demographics [age, gender, ethnicity]) and select&#xD;
           environment characteristics (i.e., participant perceptions of the intervention and&#xD;
           facility) as potential moderators of the relationship between treatment condition (OBCHI&#xD;
           versus usual care) and change in adaptation outcomes from pre- to post-intervention.&#xD;
&#xD;
      Table 1. Timeline of Person/Environment Factors, Outcomes and Tools&#xD;
&#xD;
      Person Characteristics Tools Baseline 1 wk. post 1 m. follow-up&#xD;
&#xD;
      Cognitive Screen SPMSQ x&#xD;
&#xD;
      Life Experience Interview x&#xD;
&#xD;
      Social Support Yesterday Interview x x x&#xD;
&#xD;
      Resilience Resilience Scale x&#xD;
&#xD;
      Depression GDS-15 x x x&#xD;
&#xD;
      Environment Characteristics&#xD;
&#xD;
      LTC Facility Setting Site Demographics x&#xD;
&#xD;
      Resident Perceptions SCES x x x Intervention Evaluation (midway) x&#xD;
&#xD;
      Staff Perceptions Questionnaire x x&#xD;
&#xD;
      Outcomes&#xD;
&#xD;
      QoL QOLI/SF-12 x x x&#xD;
&#xD;
      Cost Effectiveness SF-12 x x x&#xD;
&#xD;
      Activity Engagement and Social Participation Yesterday Interview x x x&#xD;
&#xD;
      Significance&#xD;
&#xD;
      As the need for LTC increases with the steady growth of older adults, relocation into&#xD;
      residential settings will grow. About 70 percent of persons over 65 will require spending&#xD;
      time in LTC services, with 40 percent requiring nursing home care for a period of time.&#xD;
      Relocation is moving from one permanent home to another permanent home which is sometimes&#xD;
      precipitated by an illness and considered a significant life event. Skinner noted a forced&#xD;
      relocation could have disturbing effects upon the elderly including loss of social and&#xD;
      community connections. However, even with a planned relocation, encountering this new and&#xD;
      unfamiliar environment requires the older person to rethink the ways in which his or her life&#xD;
      will differ with adjustment duration of a few weeks to several years. Many factors determine&#xD;
      the ways in which this 'new life' will evolve including: past adaptive strategies and life&#xD;
      experiences, family support systems, socioeconomic resources, and cultural values.&#xD;
&#xD;
      Moving from a familiar environment to an unfamiliar one involves adaptation, regardless of&#xD;
      age. Adaptation is a process involving interaction between the person and environment.&#xD;
      Indicators of successful adaptation to LTC have included: developing a sense of identity and&#xD;
      place, having care needs met, knowing and being known to other residents, maintaining or&#xD;
      developing social networks, continuity of lifestyle, and maintaining control over life&#xD;
      situations. As defined for this study, adaptation is a normal process by which a person&#xD;
      encounters a perceived challenge in the environment and is able to successfully manage that&#xD;
      challenge as measured by increased quality of life, activity engagement and social&#xD;
      participation. Central to adaptation is the cultural heritage that an individual brings to&#xD;
      the LTC facility upon relocation. Because culture is the learned beliefs, values, customs,&#xD;
      actions, communication, and life ways of an individual, it can be expected to permeate all&#xD;
      aspects of life in a residential facility. Attention to an individual's cultural heritage has&#xD;
      begun to make in-roads to the daily life routines encountered in these facilities.&#xD;
&#xD;
      Acknowledgement of the resident's culture is a major contributing factor to his/her quality&#xD;
      of life (QOL). However, QOL is a complex construct and has been used synonymously with terms&#xD;
      like well-being, life satisfaction, and functional health. Lawton asserted that QOL is a&#xD;
      collection of dimensions comprised of both objective and subjective factors which may include&#xD;
      all or some of the following: behavioral competence, objective environment, perceived QOL,&#xD;
      psychological well-being, and health-related status. Other factors associated with QOL&#xD;
      include: interaction with family and friends, personal qualities, room and meal items, number&#xD;
      of health problems, staff-resident ratios and continuity of care. These findings attest to&#xD;
      the importance of a person-environment 'match' when QOL issues for residents are considered.&#xD;
&#xD;
      Incorporating meaningful activity and social connections into the lives of elders that have&#xD;
      been circumscribed by illness and disability is particularly important to QOL. Gerontological&#xD;
      literature concerning the activities of elders has concentrated upon personal care and&#xD;
      instrumental activities and how they contribute to health and functional status. These&#xD;
      obligatory tasks are essential to one's survival, but perhaps even more significant to an&#xD;
      elder's well-being are those discretionary activities involving social and meaningful&#xD;
      occupations; such findings support the proposition that activity and social support systems&#xD;
      are important in mediating the impact of illness on well-being.&#xD;
&#xD;
      In summary, the relationship of relocation, culture, adaptation, QOL, activity engagement,&#xD;
      and social participation is reflected in outcomes where failure to provide culturally&#xD;
      competent and culturally sensitive care have occurred. With increasing diversity of the US&#xD;
      population, practitioners are challenged to deliver culturally competent services and to&#xD;
      improve the QOL for diverse LTC residents.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>Change is being assessed at baseline, 1 week and 1 month follow up</time_frame>
    <description>QOLNH by Ferran</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SF-12</measure>
    <time_frame>Change is being assessed at baseline, 1 week and 1 month follow up</time_frame>
    <description>Measurement of general health</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Fragility</condition>
  <arm_group>
    <arm_group_label>OBCHI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This small group process intervention focuses upon the cultural heritage of the residents in LTC settings measuring quality of life, activity engagement and social participation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group only received the typical activities conducted in LTC facilities.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>OBCHI</intervention_name>
    <description>Occupation-based cultural heritage intervention emphasizing the cultural background of residents in LTC settings.</description>
    <arm_group_label>OBCHI</arm_group_label>
    <other_name>occupation-based cultural heritage intervention</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speaking, less than one year from admission, cognitive level of 4/5 on SPMSQ&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non English speaking, more than one year in LTC, and less than cut off score on SPMSQ&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Donna Tilley, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Texas Woman's University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Texas Woman's University</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>January 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>January 2, 2017</last_update_submitted>
  <last_update_submitted_qc>January 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be presented without names and by treatment and/or control group. Information may include: gender, age, ethnicity, education level, and/or scores from the outcome measures. This information will be shared via publications and professional presentations.&#xD;
The IRB is currently approved and continues to be renewed on a yearly basis. Contact the PI for further information.</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/NCT03009851
org study id: RRF 2014-090
nct id: NCT03009851
lead sponsor: 
collaborator: 
has dmc: No
The goals of the proposed research were to:

        1. describe the person and environment characteristics and activity patterns of residents
           in long-term care (LTC) facilities;

        2. modify the evidence-based, occupation-based cultural heritage intervention (OBCHI)
           grounded on the results of Aim 1;

        3. test the effectiveness of the OBCHI intended to facilitate adaptation to relocation into
           LTC facilities relative to a usual activities group;

        4. determine the cost-effectiveness of the intervention conducted by in-house staff
           compared to the control group; and

        5. examine person and environment factors as potential moderators of the relationship
           between treatment condition and adaptation outcomes.
Specific Aims

      Primary Aims

        1. Describe the person and environment characteristics and activity patterns of residents
           in LTC facilities.

        2. Modify the OBCHI grounded on the evidence-based results of Aim 1 specific to these
           facilities and residents.

        3. Test the effectiveness of the OBCHI conducted by activity department staff, relative to
           usual activities, as measured by quality of life, activity engagement, and social
           participation.

           H1a-c: Those receiving OBCHI will have significantly greater improvement in

           a) quality of life, b) activity engagement, and c) social participation at
           post-intervention relative to those receiving usual activities.

           H2a-c: Those receiving OBCHI will have greater maintenance of improvements in a) quality
           of life, b) activity engagement, and c) social participation at 1-month follow-up,
           relative to those receiving usual activities.

        4. Determine the cost-effectiveness of the intervention in terms of quality adjusted life
           year (QALY) and other health factors.

           H3: When OBCHI is proven to be more effective in promoting quality of life than usual
           activities, the investigators will expect the OBCHI to produce a higher QALY at a lower
           cost per QALY.

           H4: Between these two mutually exclusive treatments, the OBCHI intervention will be more
           efficient (more effective and less costly) or cost saving with a negative incremental
           cost-effectiveness ratio (ICER) when compared to those receiving usual activities.

           Exploratory Aim

        5. Examine person characteristics (i.e. cultural heritage, life experiences social support,
           resilience, depression, and resident demographics [age, gender, ethnicity]) and select
           environment characteristics (i.e., participant perceptions of the intervention and
           facility) as potential moderators of the relationship between treatment condition (OBCHI
           versus usual care) and change in adaptation outcomes from pre- to post-intervention.

      Table 1. Timeline of Person/Environment Factors, Outcomes and Tools

      Person Characteristics Tools Baseline 1 wk. post 1 m. follow-up

      Cognitive Screen SPMSQ x

      Life Experience Interview x

      Social Support Yesterday Interview x x x

      Resilience Resilience Scale x

      Depression GDS-15 x x x

      Environment Characteristics

      LTC Facility Setting Site Demographics x

      Resident Perceptions SCES x x x Intervention Evaluation (midway) x

      Staff Perceptions Questionnaire x x

      Outcomes

      QoL QOLI/SF-12 x x x

      Cost Effectiveness SF-12 x x x

      Activity Engagement and Social Participation Yesterday Interview x x x

      Significance

      As the need for LTC increases with the steady growth of older adults, relocation into
      residential settings will grow. About 70 percent of persons over 65 will require spending
      time in LTC services, with 40 percent requiring nursing home care for a period of time.
      Relocation is moving from one permanent home to another permanent home which is sometimes
      precipitated by an illness and considered a significant life event. Skinner noted a forced
      relocation could have disturbing effects upon the elderly including loss of social and
      community connections. However, even with a planned relocation, encountering this new and
      unfamiliar environment requires the older person to rethink the ways in which his or her life
      will differ with adjustment duration of a few weeks to several years. Many factors determine
      the ways in which this 'new life' will evolve including: past adaptive strategies and life
      experiences, family support systems, socioeconomic resources, and cultural values.

      Moving from a familiar environment to an unfamiliar one involves adaptation, regardless of
      age. Adaptation is a process involving interaction between the person and environment.
      Indicators of successful adaptation to LTC have included: developing a sense of identity and
      place, having care needs met, knowing and being known to other residents, maintaining or
      developing social networks, continuity of lifestyle, and maintaining control over life
      situations. As defined for this study, adaptation is a normal process by which a person
      encounters a perceived challenge in the environment and is able to successfully manage that
      challenge as measured by increased quality of life, activity engagement and social
      participation. Central to adaptation is the cultural heritage that an individual brings to
      the LTC facility upon relocation. Because culture is the learned beliefs, values, customs,
      actions, communication, and life ways of an individual, it can be expected to permeate all
      aspects of life in a residential facility. Attention to an individual's cultural heritage has
      begun to make in-roads to the daily life routines encountered in these facilities.

      Acknowledgement of the resident's culture is a major contributing factor to his/her quality
      of life (QOL). However, QOL is a complex construct and has been used synonymously with terms
      like well-being, life satisfaction, and functional health. Lawton asserted that QOL is a
      collection of dimensions comprised of both objective and subjective factors which may include
      all or some of the following: behavioral competence, objective environment, perceived QOL,
      psychological well-being, and health-related status. Other factors associated with QOL
      include: interaction with family and friends, personal qualities, room and meal items, number
      of health problems, staff-resident ratios and continuity of care. These findings attest to
      the importance of a person-environment 'match' when QOL issues for residents are considered.

      Incorporating meaningful activity and social connections into the lives of elders that have
      been circumscribed by illness and disability is particularly important to QOL. Gerontological
      literature concerning the activities of elders has concentrated upon personal care and
      instrumental activities and how they contribute to health and functional status. These
      obligatory tasks are essential to one's survival, but perhaps even more significant to an
      elder's well-being are those discretionary activities involving social and meaningful
      occupations; such findings support the proposition that activity and social support systems
      are important in mediating the impact of illness on well-being.

      In summary, the relationship of relocation, culture, adaptation, QOL, activity engagement,
      and social participation is reflected in outcomes where failure to provide culturally
      competent and culturally sensitive care have occurred. With increasing diversity of the US
      population, practitioners are challenged to deliver culturally competent services and to
      improve the QOL for diverse LTC residents.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Quality of Life
time frame: Change is being assessed at baseline, 1 week and 1 month follow up
description: QOLNH by Ferran
measure: SF-12
time frame: Change is being assessed at baseline, 1 week and 1 month follow up
description: Measurement of general health
arm group label: OBCHI
arm group type: Experimental
description: This small group process intervention focuses upon the cultural heritage of the residents in LTC settings measuring quality of life, activity engagement and social participation.
arm group label: Control
arm group type: No Intervention
description: The control group only received the typical activities conducted in LTC facilities.
intervention type: Behavioral
intervention name: OBCHI
description: Occupation-based cultural heritage intervention emphasizing the cultural background of residents in LTC settings.
arm group label: OBCHI
other name: occupation-based cultural heritage intervention
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Donna Tilley, PhD
role: Study Director
affiliation: Texas Woman's University
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Data will be presented without names and by treatment and/or control group. Information may include: gender, age, ethnicity, education level, and/or scores from the outcome measures. This information will be shared via publications and professional presentations.
The IRB is currently approved and continues to be renewed on a yearly basis. Contact the PI for further information.