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/NCT05980299</url>
    </required_header>
    <id_info>
      <org_study_id>FY22_Pilot5_Abbott</org_study_id>
      <secondary_id>U54AG063546</secondary_id>
      <secondary_id>403853</secondary_id>
      <nct_id>NCT05980299</nct_id>
    </id_info>
    <brief_title>Testing the Feasibility of the Individualized Positive Psychosocial Intervention (IPPI)</brief_title>
    <acronym>IPPI</acronym>
    <official_title>Testing the Feasibility of the Individualized Positive Psychosocial Intervention (IPPI)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Miami University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>United Church Homes</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Penn State University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Virginia Polytechnic Institute and State University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>National Institute on Aging (NIA)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Miami University</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 goal of this clinical trial is to test the feasibility of the Individualized Positive&#xD;
        Psychosocial Interaction (IPPI) with 108 nursing home residents living with dementia and&#xD;
        distress or depressive symptoms. The main questions it aims to answer are: •is it feasible to&#xD;
        deliver the IPPI and track impact through data collected in the electronic medical records.&#xD;
        Care partners will engage eligible residents in 2 brief preference-based IPPIs per week over&#xD;
        the course of 6 months.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Specific Aims. Psychological and behavioral symptoms of distress (BPSD) expressed by people&#xD;
        living with dementia (PLWD) are challenging to respond to in nursing home (NH) care.&#xD;
        Experienced by 78% of PLWD, BPSD can include wandering, persistent vocalizations, and&#xD;
        resistance or refusal of care.1 In addition, 30% of NH residents experience depressive&#xD;
        symptoms2 and among those with depressive symptoms, 47% also have dementia.3 Together, these&#xD;
        conditions will be referred to as distress throughout this proposal. Without appropriate&#xD;
        guidance or training, care partners (e.g., Certified Nursing Assistants) struggle to prevent&#xD;
        or positively remediate distress experienced by PLWD. The Individualized Positive&#xD;
        Psychosocial Intervention (IPPI) is an evidence-based program designed to support care&#xD;
        partners in engaging PLWD with brief (i.e.,10 minute) one-to-one preference-based activities.&#xD;
        IPPI is designed to enhance well-being and reduce negative emotional and behavioral responses&#xD;
        using non-pharmacological approaches that align care with residents' preferences recorded in&#xD;
        Section F of the MDS (e.g., choose what clothes to wear). Specifically, in our IPPI&#xD;
        randomized controlled trial (RCT) effectiveness trial,4 NH residents receiving the IPPI&#xD;
        program delivered by care partners experienced more pleasure, alertness, engagement, and&#xD;
        positive verbal behavior compared with the usual care group.&#xD;
  &#xD;
        Our goal with this proposal is to partner with United Church Homes (UCH), a 106-year-old&#xD;
        nonprofit national senior living provider to conduct a full implementation feasibility pilot&#xD;
        of the IPPI program with long-stay residents in 9 of their NHs. Our objective is to conduct a&#xD;
        pilot study to evaluate 1) the ability of staff to identify residents who are optimal for the&#xD;
        IPPI, 2) implementation of IPPI, and 3) the impact on pragmatic clinical outcome measures&#xD;
        (BPSD and depressive symptoms). Staff champions will be identified by the stakeholder team in&#xD;
        each NH (e.g., Director of Nursing, Activity Professional) and trained to identify residents&#xD;
        optimal for the IPPI (i.e., experiencing cognitive impairment (Minimum Data Set (MDS) Brief&#xD;
        Inventory for Mental Status (BIMS) score 0-12) as well as documentation (MDS Section E or D)&#xD;
        of distress within the past 3-months. Distress is indicated by a 1 or higher on any of the 5&#xD;
        behavior items from MDS Section E (i.e., physical, verbal, other behavior, rejection of care,&#xD;
        wandering) and/or a score of 1 or higher on one of 5 MDS section D items (i.e., anhedonia,&#xD;
        sad mood, poor self-esteem, poor appetite, restlessness).&#xD;
  &#xD;
        Care partners of identified residents will be invited to be trained to deliver IPPI. The&#xD;
        investigators anticipate that each NH will initiate engagement with 4-5 residents per month&#xD;
        for each of 3 consecutive months (12-15 residents per NH) in addition to 3-4 care partners&#xD;
        who will deliver the IPPI. Resident initiation in the program will occur on a rolling basis&#xD;
        (i.e., initiating intervention activities for a given resident when he/she is due for a&#xD;
        routine quarterly care plan review). Each selected resident will then receive 2 IPPI sessions&#xD;
        per week for 6 months. The project seeks to achieve the following specific aims:&#xD;
  &#xD;
        Aim 1. To conduct a pilot embedded Pragmatic Clinical Trial (ePCT) to evaluate and establish&#xD;
        the feasibility of implementing the IPPI program in 9 NHs among 108-135 residents.&#xD;
        Quantitative implementation endpoints indicating success include (a) that staff in each&#xD;
        community will be able to identify and engage 12-15 residents experiencing both dementia&#xD;
        (e.g., BIMS 0-12) and distress (either BPSD or depressive symptoms) within the past 2 weeks,&#xD;
        measured by a count of participants; (b) that all the implementation team members (champions&#xD;
        and care partners) can complete the online training within the first two months of initiating&#xD;
        implementation, as indicated by the learning management system; (c) that the implementation&#xD;
        team will be able to (i) review existing data from Section F of the MDS for all selected&#xD;
        residents; (ii) identify a match between a resident's important preferences and 1-2 IPPI&#xD;
        protocols; (iii) identify a targeted expression of distress as measured by documentation in&#xD;
        the electronic medical record; and (d) that staff can conduct at least 2 ten-minute sessions&#xD;
        per week, per targeted resident with fidelity over the course of 6 months as measured in the&#xD;
        electronic medial record (EMR). Qualitative data to evaluate implementation will be&#xD;
        ascertained from semi-structured interviews with implementation team members in each&#xD;
        community to assess acceptability, feasibility, and appropriateness as well as facilitators&#xD;
        and barriers to fidelity of the IPPI sessions.&#xD;
  &#xD;
        Aim 2. To establish the feasibility of tracking intervention impact on a primary clinical&#xD;
        outcome of a targeted behavior (identified by staff) through the MDS Section E (E0200A, B or&#xD;
        C; or E0800) or MDS Section D (Patient Health Questionnaire (PHQ-9) items of anhedonia, sad&#xD;
        mood, poor self-esteem, poor appetite, or restlessness). The primary outcome measure will&#xD;
        consist of a single variable indicating improvement, no change, or worsening of a&#xD;
        staff-targeted behavior of distress of each resident receiving the intervention, tracked pre-&#xD;
        and post-IPPI intervention using routinely collected data in the EMR. Secondary staff&#xD;
        outcomes will include knowledge of emotion-focused communication and staff reported&#xD;
        self-efficacy in applying the communication skills.&#xD;
  &#xD;
        IMPACT: The IPPI program teaches care partners strategies to better identify and manage their&#xD;
        own feelings and those of PLWD through our emotion-focused communication course. In addition,&#xD;
        the program provides highly structured and feasible protocols to guide short but impactful&#xD;
        interactions with PLWD designed to prevent and remediate distress (i.e., BPSD and symptoms of&#xD;
        depression). Findings from this pilot study will guide the implementation, approach, and&#xD;
        power needed for a full-scale Stage IV effectiveness ePCT study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 10, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Behavioral or Psychological Symptoms of Dementia or Depressive Symptoms</measure>
      <time_frame>6 Months</time_frame>
      <description>The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress: Minimum Data Set (MDS) Section E (E0200A, B or C; or E0800) or MDS Section D (Patient Health Questionnaire (PHQ-9) items of anhedonia, sad mood, poor self-esteem, poor appetite, or restlessness) the investigators will look to see if that item has decreased (moved to zero) on the 6 month MDS follow-up. Lower scores (zero) indicate no distress while higher scores (1 or greater) indicate distress.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Staff-Reported</measure>
      <time_frame>1 month</time_frame>
      <description>Secondary staff outcomes will include knowledge of emotion-focused communication and staff reported self-efficacy in applying the communication skills as measured via a pre and post test administered just before and immediately after completing the training.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">108</enrollment>
    <condition>Dementia</condition>
    <condition>Depression</condition>
    <condition>Behavior</condition>
    <arm_group>
      <arm_group_label>experimental</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The experimental arm involves a brief positive interaction around a preferred activity or personal care routine.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Individualized Positive Psychosocial Interaction</intervention_name>
      <description>The intervention involves a brief positive interaction around a preferred activity or personal care routine.</description>
      <arm_group_label>experimental</arm_group_label>
      <other_name>Individualized Positive Psychosocial Intervention</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Eligibility for Individualized Positive Psychosocial Interaction (IPPI)&#xD;
  &#xD;
            1. Be a long-term resident in a nursing home&#xD;
  &#xD;
            2. Have a score of 0-12 on the Brief Inventory for Mental Status (BIMS)&#xD;
  &#xD;
            3. Either (could be both) on their most recent Minimum Data Set (MDS) 3.0 assessment A&#xD;
               score of 1 or higher on any of the 5 behavior items from MDS Section E (i.e.,&#xD;
               physical, verbal, other behavior, rejection of care, wandering) A score of 1 or higher&#xD;
               on one of 5 MDS section D items (i.e., anhedonia, sad mood, poor self-esteem, poor&#xD;
               appetite, restlessness)&#xD;
  &#xD;
          Exclusion Criteria: Nursing home residents who are expected to live in the community for&#xD;
          less than 6 months.&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>110 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Katherine Abbott, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Miami University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Katherine Abbott, PhD</last_name>
      <phone>5135290869</phone>
      <email>abbottkm@miamioh.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>The Trinity Community at Beavercreek</name>
        <address>
          <city>Beavercreek</city>
          <state>Ohio</state>
          <zip>45440</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Laura Farrell</last_name>
        <phone>937-426-8481</phone>
        <email>lfarrell@uchinc.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Chapel Hill Community</name>
        <address>
          <city>Canal Fulton</city>
          <state>Ohio</state>
          <zip>44614</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Josh Kerr</last_name>
        <phone>330-854-4177</phone>
        <email>jkerr@uchinc.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Trinity Community at Fairborn</name>
        <address>
          <city>Fairborn</city>
          <state>Ohio</state>
          <zip>45324</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Jeremy Lemon</last_name>
        <phone>937-878-0262</phone>
        <email>JLemon@uchinc.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Four Winds Community</name>
        <address>
          <city>Jackson</city>
          <state>Ohio</state>
          <zip>45640</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Mary Faye</last_name>
        <phone>740-286-7551</phone>
        <email>MFaye@uchinc.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Harmar Place Community</name>
        <address>
          <city>Marietta</city>
          <state>Ohio</state>
          <zip>45750</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Sue Boulton</last_name>
        <phone>740-376-5600</phone>
        <email>SBoulton@uchinc.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>SEM Haven</name>
        <address>
          <city>Milford</city>
          <state>Ohio</state>
          <zip>45150</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Jessica Hall</last_name>
        <phone>513-248-1270</phone>
        <email>jhall@semhaven.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Parkvue Community</name>
        <address>
          <city>Sandusky</city>
          <state>Ohio</state>
          <zip>44870</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Dan Miller</last_name>
        <phone>419-621-1900</phone>
        <email>dmiller@uchinc.org</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://www.preferencebasedliving.com/ippi/individualized-positive-psychosocial-intervention-protocol-ippi/</url>
      <description>IPPI program</description>
    </link>
    <results_reference>
      <citation>Van Haitsma KS, Curyto K, Abbott KM, Towsley GL, Spector A, Kleban M. A randomized controlled trial for an individualized positive psychosocial intervention for the affective and behavioral symptoms of dementia in nursing home residents. J Gerontol B Psychol Sci Soc Sci. 2015 Jan;70(1):35-45. doi: 10.1093/geronb/gbt102. Epub 2013 Dec 4.</citation>
      <PMID>24304555</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>dementia</keyword>
    <keyword>depressive symptoms</keyword>
    <keyword>psychosocial intervention</keyword>
    <keyword>feasibility</keyword>
    <keyword>emotion</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dementia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>There is not a plan to make individual participant data (IPT) available.</ipd_description>
    </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/NCT05980299
  org study id: FY22_Pilot5_Abbott
  secondary id: U54AG063546
  secondary id: 403853
  nct id: NCT05980299
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to test the feasibility of the Individualized Positive
        Psychosocial Interaction (IPPI) with 108 nursing home residents living with dementia and
        distress or depressive symptoms. The main questions it aims to answer are: •is it feasible to
        deliver the IPPI and track impact through data collected in the electronic medical records.
        Care partners will engage eligible residents in 2 brief preference-based IPPIs per week over
        the course of 6 months.
  Specific Aims. Psychological and behavioral symptoms of distress (BPSD) expressed by people
        living with dementia (PLWD) are challenging to respond to in nursing home (NH) care.
        Experienced by 78% of PLWD, BPSD can include wandering, persistent vocalizations, and
        resistance or refusal of care.1 In addition, 30% of NH residents experience depressive
        symptoms2 and among those with depressive symptoms, 47% also have dementia.3 Together, these
        conditions will be referred to as distress throughout this proposal. Without appropriate
        guidance or training, care partners (e.g., Certified Nursing Assistants) struggle to prevent
        or positively remediate distress experienced by PLWD. The Individualized Positive
        Psychosocial Intervention (IPPI) is an evidence-based program designed to support care
        partners in engaging PLWD with brief (i.e.,10 minute) one-to-one preference-based activities.
        IPPI is designed to enhance well-being and reduce negative emotional and behavioral responses
        using non-pharmacological approaches that align care with residents' preferences recorded in
        Section F of the MDS (e.g., choose what clothes to wear). Specifically, in our IPPI
        randomized controlled trial (RCT) effectiveness trial,4 NH residents receiving the IPPI
        program delivered by care partners experienced more pleasure, alertness, engagement, and
        positive verbal behavior compared with the usual care group.
  
        Our goal with this proposal is to partner with United Church Homes (UCH), a 106-year-old
        nonprofit national senior living provider to conduct a full implementation feasibility pilot
        of the IPPI program with long-stay residents in 9 of their NHs. Our objective is to conduct a
        pilot study to evaluate 1) the ability of staff to identify residents who are optimal for the
        IPPI, 2) implementation of IPPI, and 3) the impact on pragmatic clinical outcome measures
        (BPSD and depressive symptoms). Staff champions will be identified by the stakeholder team in
        each NH (e.g., Director of Nursing, Activity Professional) and trained to identify residents
        optimal for the IPPI (i.e., experiencing cognitive impairment (Minimum Data Set (MDS) Brief
        Inventory for Mental Status (BIMS) score 0-12) as well as documentation (MDS Section E or D)
        of distress within the past 3-months. Distress is indicated by a 1 or higher on any of the 5
        behavior items from MDS Section E (i.e., physical, verbal, other behavior, rejection of care,
        wandering) and/or a score of 1 or higher on one of 5 MDS section D items (i.e., anhedonia,
        sad mood, poor self-esteem, poor appetite, restlessness).
  
        Care partners of identified residents will be invited to be trained to deliver IPPI. The
        investigators anticipate that each NH will initiate engagement with 4-5 residents per month
        for each of 3 consecutive months (12-15 residents per NH) in addition to 3-4 care partners
        who will deliver the IPPI. Resident initiation in the program will occur on a rolling basis
        (i.e., initiating intervention activities for a given resident when he/she is due for a
        routine quarterly care plan review). Each selected resident will then receive 2 IPPI sessions
        per week for 6 months. The project seeks to achieve the following specific aims:
  
        Aim 1. To conduct a pilot embedded Pragmatic Clinical Trial (ePCT) to evaluate and establish
        the feasibility of implementing the IPPI program in 9 NHs among 108-135 residents.
        Quantitative implementation endpoints indicating success include (a) that staff in each
        community will be able to identify and engage 12-15 residents experiencing both dementia
        (e.g., BIMS 0-12) and distress (either BPSD or depressive symptoms) within the past 2 weeks,
        measured by a count of participants; (b) that all the implementation team members (champions
        and care partners) can complete the online training within the first two months of initiating
        implementation, as indicated by the learning management system; (c) that the implementation
        team will be able to (i) review existing data from Section F of the MDS for all selected
        residents; (ii) identify a match between a resident's important preferences and 1-2 IPPI
        protocols; (iii) identify a targeted expression of distress as measured by documentation in
        the electronic medical record; and (d) that staff can conduct at least 2 ten-minute sessions
        per week, per targeted resident with fidelity over the course of 6 months as measured in the
        electronic medial record (EMR). Qualitative data to evaluate implementation will be
        ascertained from semi-structured interviews with implementation team members in each
        community to assess acceptability, feasibility, and appropriateness as well as facilitators
        and barriers to fidelity of the IPPI sessions.
  
        Aim 2. To establish the feasibility of tracking intervention impact on a primary clinical
        outcome of a targeted behavior (identified by staff) through the MDS Section E (E0200A, B or
        C; or E0800) or MDS Section D (Patient Health Questionnaire (PHQ-9) items of anhedonia, sad
        mood, poor self-esteem, poor appetite, or restlessness). The primary outcome measure will
        consist of a single variable indicating improvement, no change, or worsening of a
        staff-targeted behavior of distress of each resident receiving the intervention, tracked pre-
        and post-IPPI intervention using routinely collected data in the EMR. Secondary staff
        outcomes will include knowledge of emotion-focused communication and staff reported
        self-efficacy in applying the communication skills.
  
        IMPACT: The IPPI program teaches care partners strategies to better identify and manage their
        own feelings and those of PLWD through our emotion-focused communication course. In addition,
        the program provides highly structured and feasible protocols to guide short but impactful
        interactions with PLWD designed to prevent and remediate distress (i.e., BPSD and symptoms of
        depression). Findings from this pilot study will guide the implementation, approach, and
        power needed for a full-scale Stage IV effectiveness ePCT study.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Behavioral or Psychological Symptoms of Dementia or Depressive Symptoms
  time frame: 6 Months
  description: The investigators are using a person-centered outcome measure. If the participant has an indicate of 1 or more on any of the following items that indicate distress: Minimum Data Set (MDS) Section E (E0200A, B or C; or E0800) or MDS Section D (Patient Health Questionnaire (PHQ-9) items of anhedonia, sad mood, poor self-esteem, poor appetite, or restlessness) the investigators will look to see if that item has decreased (moved to zero) on the 6 month MDS follow-up. Lower scores (zero) indicate no distress while higher scores (1 or greater) indicate distress.
  measure: Staff-Reported
  time frame: 1 month
  description: Secondary staff outcomes will include knowledge of emotion-focused communication and staff reported self-efficacy in applying the communication skills as measured via a pre and post test administered just before and immediately after completing the training.
  arm group label: experimental
  arm group type: Experimental
  description: The experimental arm involves a brief positive interaction around a preferred activity or personal care routine.
  intervention type: Behavioral
  intervention name: Individualized Positive Psychosocial Interaction
  description: The intervention involves a brief positive interaction around a preferred activity or personal care routine.
  arm group label: experimental
  other name: Individualized Positive Psychosocial Intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 110 Years
  healthy volunteers: No
  last name: Katherine Abbott, PhD
  role: Principal Investigator
  affiliation: Miami University
  last name: Katherine Abbott, PhD
  phone: 5135290869
  email: abbottkm@miamioh.edu
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  country: United States
  url: https://www.preferencebasedliving.com/ippi/individualized-positive-psychosocial-intervention-protocol-ippi/
  description: IPPI program
  citation: Van Haitsma KS, Curyto K, Abbott KM, Towsley GL, Spector A, Kleban M. A randomized controlled trial for an individualized positive psychosocial intervention for the affective and behavioral symptoms of dementia in nursing home residents. J Gerontol B Psychol Sci Soc Sci. 2015 Jan;70(1):35-45. doi: 10.1093/geronb/gbt102. Epub 2013 Dec 4.
  PMID: 24304555
  responsible party type: Sponsor
  mesh term: Dementia
  sharing ipd: No
  ipd description: There is not a plan to make individual participant data (IPT) available.