<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/NCT03264378</url>
  </required_header>
  <id_info>
    <org_study_id>2017P000186/PHS</org_study_id>
    <nct_id>NCT03264378</nct_id>
  </id_info>
  <brief_title>Partnership in Implementation Science for Geriatric Mental Health (PRISM)</brief_title>
  <official_title>Partnership in Implementation Science for Geriatric Mental Health (PRISM)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Society and Health Institute (Thailand)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Mental Health Center (China)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Brigham and Women's Hospital</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 Partnership in Implementation Science for Geriatric Mental Health (PRISM) project&#xD;
      proposes an evidence-based physical exercise intervention for older adults who exhibit&#xD;
      behavioral and psychological symptoms of dementia (BPSD). The proposed evaluation study will&#xD;
      conduct a randomized controlled trial with a Hybrid Type 3 design to compare the intervention&#xD;
      arm that implements the culturally-adapted GTO model (GTO-ThAI) to deliver implementation&#xD;
      support, with a control arm, which receives usual top-down administrative instruction for&#xD;
      implementing a policy initiative.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall goal of this project is to establish a hub to integrate implementation research&#xD;
      for scaling up sustainable, evidence-based mental health interventions with research&#xD;
      capacity-building activities for East Asia. Specific scale-up study aims include: Aim 1:&#xD;
      Assessing readiness for implementing the evidence-based physical exercise intervention for&#xD;
      improving mental health of older adults in participating provinces of Thailand; Aim 2:&#xD;
      Developing the GTO-ThAI implementation support model through a pre-implementation case study&#xD;
      and formative evaluation; and Aim 3: Evaluation of implementation strategies and clinical&#xD;
      outcomes through a hybrid Type 3 randomized trial to test an evidence-based implementation&#xD;
      support strategy (i.e., the GTO-ThAI model) that emphasizes a systematic process to address&#xD;
      implementation barriers to the delivery of the evidence-based physical exercise intervention&#xD;
      (PEI), compared with the existing standard administrative procedures for delivering the same&#xD;
      PEI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2021</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>The experimental group will receive physical exercise intervention (PEI) that is supported by standardized administrative procedures plus the GTO-ThAI implementation support system designed to improve the quality of implementation of the PEI program. The active comparator group will receive PEI that is supported only by standardized administrative procedures that the Thai government typically uses to promote policy-driven initiatives.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>None of participants, care providers, or outcome assessor knows whether which participants have been assigned to intervention or control condition.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Implementation outcome score</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Adapted from the Quality Implementation Tool (Meyer et al., 2012), using a total score based on average of ratings, by site implementation team leaders, on a 7-point Likert scale over 48 items across eight dimensions of implementation (e.g. adoption, fidelity, dosage, program reach, differentiation, quality of implementation, implementation cost, sustainability).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Behavioral and psychological symptoms of dementia (BPSD)</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>BPSD will be assessed by the Neuropsychiatric Inventory (NPI), using the total score obtained by summing all the individual domain total scores; each domain score is the product of the frequency score multiplied by the severity score for that behavioral domain.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">350</enrollment>
  <condition>Behavioral and Psychological Symptoms of Dementia (BPSD)</condition>
  <arm_group>
    <arm_group_label>PEI-GTO-ThAI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Physical exercise intervention (PEI) supported by the GTO-ThAI Implementation Model</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PEI-Standard</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Physical exercise intervention (PEI) supported by the standard governmental administrative procedures</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical Exercise Intervention</intervention_name>
    <description>The 12-week physical exercise intervention will be delivered by trained community health workers (CHW) who are supervised by nurses. The CHW will visit the patient's home-3 sessions per week for the first 2 weeks, followed by weekly visits for 6 weeks, and then weekly telephone support for 4 weeks-to instruct the family caregiver and the patient in the exercise routine. Each session includes physical activities designed to promote gentle stretching, strength, balance, flexibility, and endurance, with a progressive schedule (i.e., the total length of time increases from 10 minutes up to 30 minutes maximum) and its intensity adjusted based on the participant's level of fitness.</description>
    <arm_group_label>PEI-GTO-ThAI</arm_group_label>
    <arm_group_label>PEI-Standard</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  (a) adults who are aged 55 and older,&#xD;
&#xD;
          -  (b) screen positive for dementia,&#xD;
&#xD;
          -  (c) screen positive for BPSD, and&#xD;
&#xD;
          -  (d) having a caregiver who is willing to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (a) caregivers who are cognitively not intact, and/or&#xD;
&#xD;
          -  (b) not willing to participate in the intervention.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hongtu Chen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Komatra Chuengsatiansup, MD</last_name>
    <phone>+66814411401</phone>
    <email>loxlix@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ministry of Public Health</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Komatra Chuengsatiansup, MD</last_name>
      <phone>+66 626016116</phone>
      <email>loxlix@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Siranee Sihapark, PhD</last_name>
      <phone>+66 810551215</phone>
      <email>daosiam@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>April 29, 2021</last_update_submitted>
  <last_update_submitted_qc>April 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Hongtu Chen</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <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>We don't have a plan to share individual participant data.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03264378
org study id: 2017P000186/PHS
nct id: NCT03264378
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Partnership in Implementation Science for Geriatric Mental Health (PRISM) project
      proposes an evidence-based physical exercise intervention for older adults who exhibit
      behavioral and psychological symptoms of dementia (BPSD). The proposed evaluation study will
      conduct a randomized controlled trial with a Hybrid Type 3 design to compare the intervention
      arm that implements the culturally-adapted GTO model (GTO-ThAI) to deliver implementation
      support, with a control arm, which receives usual top-down administrative instruction for
      implementing a policy initiative.
The overall goal of this project is to establish a hub to integrate implementation research
      for scaling up sustainable, evidence-based mental health interventions with research
      capacity-building activities for East Asia. Specific scale-up study aims include: Aim 1:
      Assessing readiness for implementing the evidence-based physical exercise intervention for
      improving mental health of older adults in participating provinces of Thailand; Aim 2:
      Developing the GTO-ThAI implementation support model through a pre-implementation case study
      and formative evaluation; and Aim 3: Evaluation of implementation strategies and clinical
      outcomes through a hybrid Type 3 randomized trial to test an evidence-based implementation
      support strategy (i.e., the GTO-ThAI model) that emphasizes a systematic process to address
      implementation barriers to the delivery of the evidence-based physical exercise intervention
      (PEI), compared with the existing standard administrative procedures for delivering the same
      PEI.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The experimental group will receive physical exercise intervention (PEI) that is supported by standardized administrative procedures plus the GTO-ThAI implementation support system designed to improve the quality of implementation of the PEI program. The active comparator group will receive PEI that is supported only by standardized administrative procedures that the Thai government typically uses to promote policy-driven initiatives.
primary purpose: Health Services Research
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: None of participants, care providers, or outcome assessor knows whether which participants have been assigned to intervention or control condition.
measure: Implementation outcome score
time frame: Up to 12 months
description: Adapted from the Quality Implementation Tool (Meyer et al., 2012), using a total score based on average of ratings, by site implementation team leaders, on a 7-point Likert scale over 48 items across eight dimensions of implementation (e.g. adoption, fidelity, dosage, program reach, differentiation, quality of implementation, implementation cost, sustainability).
measure: Behavioral and psychological symptoms of dementia (BPSD)
time frame: Up to 12 months
description: BPSD will be assessed by the Neuropsychiatric Inventory (NPI), using the total score obtained by summing all the individual domain total scores; each domain score is the product of the frequency score multiplied by the severity score for that behavioral domain.
arm group label: PEI-GTO-ThAI
arm group type: Experimental
description: Physical exercise intervention (PEI) supported by the GTO-ThAI Implementation Model
arm group label: PEI-Standard
arm group type: Active Comparator
description: Physical exercise intervention (PEI) supported by the standard governmental administrative procedures
intervention type: Behavioral
intervention name: Physical Exercise Intervention
description: The 12-week physical exercise intervention will be delivered by trained community health workers (CHW) who are supervised by nurses. The CHW will visit the patient's home-3 sessions per week for the first 2 weeks, followed by weekly visits for 6 weeks, and then weekly telephone support for 4 weeks-to instruct the family caregiver and the patient in the exercise routine. Each session includes physical activities designed to promote gentle stretching, strength, balance, flexibility, and endurance, with a progressive schedule (i.e., the total length of time increases from 10 minutes up to 30 minutes maximum) and its intensity adjusted based on the participant's level of fitness.
arm group label: PEI-GTO-ThAI
arm group label: PEI-Standard
criteria: 
gender: All
minimum age: 55 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hongtu Chen, PhD
role: Principal Investigator
affiliation: Brigham and Women's Hospital
last name: Komatra Chuengsatiansup, MD
phone: +66814411401
email: loxlix@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Hongtu Chen
investigator title: Assistant Professor
mesh term: Dementia
sharing ipd: No
ipd description: We don't have a plan to share individual participant data.