<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/NCT04507633</url>
  </required_header>
  <id_info>
    <org_study_id>N202005108</org_study_id>
    <nct_id>NCT04507633</nct_id>
  </id_info>
  <brief_title>ROMA (Reminiscence, Reality Orientation, Music and Art ) Therapy, Cognition, Depression and Behavioral Problems in the Population With Dementia</brief_title>
  <official_title>The Effect of ROMA Therapy on Improving Cognitive Functions, Depressive Symptoms and Behavioral Problems in the Population With Dementia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Medical 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>
      This study aimed to conduct a randomized controlled trial to examine the effectiveness of&#xD;
      ROMA therapy( Reminiscence, Reality Orientation, Music, and Art) on improving cognitive&#xD;
      function, behavioral and psychological symptoms in population with dementia. The hypotheis of&#xD;
      this study is that these patients with dementia receiving ROMA therapy featuring&#xD;
      reminiscence, reality orientation, music, and art would improve their cognition, depressive&#xD;
      symptoms, and behavioral symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aimed to conduct a randomized controlled trial to examine the effectiveness of&#xD;
      ROMA therapy( Reminiscence, Reality Orientation, Music, and Art) on improving cognitive&#xD;
      function, behavioral and psychological symptoms in demented population. A total of 60&#xD;
      patients with mild to moderate dementia will be recruited and randomly assigned to two&#xD;
      groups: experimental group and control group. The experimental group will undergo ROMA&#xD;
      therapy with a 60 minute per week for eight weeks. The control group will receive three times&#xD;
      ROMA therapy after completing outcome measurements. Two groups will receive questionnaire&#xD;
      interview at pre-test, post-test, and at 4 weeks after intervention. The measurements&#xD;
      comprises: Short Portable Mental Status Questionnaire(SPMSQ), Cornell Scale for Depression in&#xD;
      Dementia(CSDD),and Neuropsychiatric Inventory-Questionnaire(NPI-Q). By identifying the&#xD;
      effectiveness of ROMA therapy, suitable intervention can be suggested for those demented&#xD;
      population to improve cognitive function, behavioral and psychological symptoms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 25, 2020</start_date>
  <completion_date type="Actual">July 31, 2021</completion_date>
  <primary_completion_date type="Actual">July 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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>independent researchers will perform intervention and data collection.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>cognitive functions</measure>
    <time_frame>cognitive functions at baseline</time_frame>
    <description>Short Portable Mental Status Questionnaire(SPMSQ)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>cognitive functions</measure>
    <time_frame>cognitive functions after the completion of intervention</time_frame>
    <description>Short Portable Mental Status Questionnaire(SPMSQ)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>cognitive functions</measure>
    <time_frame>cognitive functions at 4 weeks after the completion of intervention</time_frame>
    <description>Short Portable Mental Status Questionnaire(SPMSQ)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>depressive symptoms</measure>
    <time_frame>depressive symptoms at baseline</time_frame>
    <description>Cornell Scale for Depression in Dementia(CSDD)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>depressive symptoms</measure>
    <time_frame>depressive symptoms after the completion of intervention</time_frame>
    <description>Cornell Scale for Depression in Dementia(CSDD)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>depressive symptoms</measure>
    <time_frame>depressive symptoms at 4 weeks after the completion of intervention</time_frame>
    <description>Cornell Scale for Depression in Dementia(CSDD)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>behavioral problems</measure>
    <time_frame>behavioral problems at baseline</time_frame>
    <description>Neuropsychiatric Inventory-Questionnaire(NPI-Q)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>behavioral problems</measure>
    <time_frame>behavioral problems after the completion of intervention</time_frame>
    <description>Neuropsychiatric Inventory-Questionnaire(NPI-Q)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>behavioral problems</measure>
    <time_frame>behavioral problems at 4 weeks after the completion of intervention</time_frame>
    <description>Neuropsychiatric Inventory-Questionnaire(NPI-Q)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>ROMA therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ROMA therapy combines four elements including reminiscence, reality orientation, music, and art in the intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>usual care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ROMA therapy(reminiacence therpy, orientation, music, and art)</intervention_name>
    <description>An intervention comprising reminiscence of annual festivals, orientation, and familiar music listening and singing, and animation interaction to improve cognitive functions, depressive symptoms and behaviors problems.</description>
    <arm_group_label>ROMA therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Been diagnosed as mild to moderate dementia and CDR score between 0.5~2&#xD;
&#xD;
          2. can communicate in Chinese or Taiwanese&#xD;
&#xD;
          3. without visual or auditory impairment after equipping assist devices&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. severe dementia and Clinical Dementia Rating (CDR) score more than 2 points&#xD;
&#xD;
          2. functional dependence&#xD;
&#xD;
          3. incapable of expressing their feelings&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hui-Chuan Huang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>School of Nursing, Taipei Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yonghe Zhongxing Public Seniors Center</name>
      <address>
        <city>New Taipei City</city>
        <zip>234</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 25, 2020</study_first_submitted>
  <study_first_submitted_qc>August 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <last_update_submitted>March 18, 2022</last_update_submitted>
  <last_update_submitted_qc>March 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taipei Medical University</investigator_affiliation>
    <investigator_full_name>Huang, Hui-Chuan</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Problem Behavior</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04507633
org study id: N202005108
nct id: NCT04507633
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aimed to conduct a randomized controlled trial to examine the effectiveness of
      ROMA therapy( Reminiscence, Reality Orientation, Music, and Art) on improving cognitive
      function, behavioral and psychological symptoms in population with dementia. The hypotheis of
      this study is that these patients with dementia receiving ROMA therapy featuring
      reminiscence, reality orientation, music, and art would improve their cognition, depressive
      symptoms, and behavioral symptoms.
This study aimed to conduct a randomized controlled trial to examine the effectiveness of
      ROMA therapy( Reminiscence, Reality Orientation, Music, and Art) on improving cognitive
      function, behavioral and psychological symptoms in demented population. A total of 60
      patients with mild to moderate dementia will be recruited and randomly assigned to two
      groups: experimental group and control group. The experimental group will undergo ROMA
      therapy with a 60 minute per week for eight weeks. The control group will receive three times
      ROMA therapy after completing outcome measurements. Two groups will receive questionnaire
      interview at pre-test, post-test, and at 4 weeks after intervention. The measurements
      comprises: Short Portable Mental Status Questionnaire(SPMSQ), Cornell Scale for Depression in
      Dementia(CSDD),and Neuropsychiatric Inventory-Questionnaire(NPI-Q). By identifying the
      effectiveness of ROMA therapy, suitable intervention can be suggested for those demented
      population to improve cognitive function, behavioral and psychological symptoms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: independent researchers will perform intervention and data collection.
measure: cognitive functions
time frame: cognitive functions at baseline
description: Short Portable Mental Status Questionnaire(SPMSQ)
measure: cognitive functions
time frame: cognitive functions after the completion of intervention
description: Short Portable Mental Status Questionnaire(SPMSQ)
measure: cognitive functions
time frame: cognitive functions at 4 weeks after the completion of intervention
description: Short Portable Mental Status Questionnaire(SPMSQ)
measure: depressive symptoms
time frame: depressive symptoms at baseline
description: Cornell Scale for Depression in Dementia(CSDD)
measure: depressive symptoms
time frame: depressive symptoms after the completion of intervention
description: Cornell Scale for Depression in Dementia(CSDD)
measure: depressive symptoms
time frame: depressive symptoms at 4 weeks after the completion of intervention
description: Cornell Scale for Depression in Dementia(CSDD)
measure: behavioral problems
time frame: behavioral problems at baseline
description: Neuropsychiatric Inventory-Questionnaire(NPI-Q)
measure: behavioral problems
time frame: behavioral problems after the completion of intervention
description: Neuropsychiatric Inventory-Questionnaire(NPI-Q)
measure: behavioral problems
time frame: behavioral problems at 4 weeks after the completion of intervention
description: Neuropsychiatric Inventory-Questionnaire(NPI-Q)
arm group label: ROMA therapy
arm group type: Experimental
description: ROMA therapy combines four elements including reminiscence, reality orientation, music, and art in the intervention.
arm group label: control group
arm group type: No Intervention
description: usual care
intervention type: Behavioral
intervention name: ROMA therapy(reminiacence therpy, orientation, music, and art)
description: An intervention comprising reminiscence of annual festivals, orientation, and familiar music listening and singing, and animation interaction to improve cognitive functions, depressive symptoms and behaviors problems.
arm group label: ROMA therapy
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Hui-Chuan Huang, PhD
role: Principal Investigator
affiliation: School of Nursing, Taipei Medical University
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Taipei Medical University
investigator full name: Huang, Hui-Chuan
investigator title: Associate Professor
mesh term: Dementia
mesh term: Problem Behavior
sharing ipd: No