ROMA (Reminiscence, Reality Orientation, Music and Art ) Therapy, Cognition, Depression and Behavioral Problems in the Population With Dementia
Primary Purpose
Dementia
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
ROMA therapy(reminiacence therpy, orientation, music, and art)
Sponsored by
About this trial
This is an interventional health services research trial for Dementia
Eligibility Criteria
Inclusion Criteria:
- Been diagnosed as mild to moderate dementia and CDR score between 0.5~2
- can communicate in Chinese or Taiwanese
- without visual or auditory impairment after equipping assist devices
Exclusion Criteria:
- severe dementia and Clinical Dementia Rating (CDR) score more than 2 points
- functional dependence
- incapable of expressing their feelings
Sites / Locations
- Yonghe Zhongxing Public Seniors Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ROMA therapy
control group
Arm Description
ROMA therapy combines four elements including reminiscence, reality orientation, music, and art in the intervention.
usual care
Outcomes
Primary Outcome Measures
cognitive functions
Short Portable Mental Status Questionnaire(SPMSQ)
cognitive functions
Short Portable Mental Status Questionnaire(SPMSQ)
cognitive functions
Short Portable Mental Status Questionnaire(SPMSQ)
depressive symptoms
Cornell Scale for Depression in Dementia(CSDD)
depressive symptoms
Cornell Scale for Depression in Dementia(CSDD)
depressive symptoms
Cornell Scale for Depression in Dementia(CSDD)
behavioral problems
Neuropsychiatric Inventory-Questionnaire(NPI-Q)
behavioral problems
Neuropsychiatric Inventory-Questionnaire(NPI-Q)
behavioral problems
Neuropsychiatric Inventory-Questionnaire(NPI-Q)
Secondary Outcome Measures
Full Information
NCT ID
NCT04507633
First Posted
July 25, 2020
Last Updated
March 18, 2022
Sponsor
Taipei Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04507633
Brief Title
ROMA (Reminiscence, Reality Orientation, Music and Art ) Therapy, Cognition, Depression and Behavioral Problems in the Population With Dementia
Official Title
The Effect of ROMA Therapy on Improving Cognitive Functions, Depressive Symptoms and Behavioral Problems in the Population With Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 25, 2020 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
independent researchers will perform intervention and data collection.
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ROMA therapy
Arm Type
Experimental
Arm Description
ROMA therapy combines four elements including reminiscence, reality orientation, music, and art in the intervention.
Arm Title
control group
Arm Type
No Intervention
Arm Description
usual care
Intervention Type
Behavioral
Intervention Name(s)
ROMA therapy(reminiacence therpy, orientation, music, and art)
Intervention 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.
Primary Outcome Measure Information:
Title
cognitive functions
Description
Short Portable Mental Status Questionnaire(SPMSQ)
Time Frame
cognitive functions at baseline
Title
cognitive functions
Description
Short Portable Mental Status Questionnaire(SPMSQ)
Time Frame
cognitive functions after the completion of intervention
Title
cognitive functions
Description
Short Portable Mental Status Questionnaire(SPMSQ)
Time Frame
cognitive functions at 4 weeks after the completion of intervention
Title
depressive symptoms
Description
Cornell Scale for Depression in Dementia(CSDD)
Time Frame
depressive symptoms at baseline
Title
depressive symptoms
Description
Cornell Scale for Depression in Dementia(CSDD)
Time Frame
depressive symptoms after the completion of intervention
Title
depressive symptoms
Description
Cornell Scale for Depression in Dementia(CSDD)
Time Frame
depressive symptoms at 4 weeks after the completion of intervention
Title
behavioral problems
Description
Neuropsychiatric Inventory-Questionnaire(NPI-Q)
Time Frame
behavioral problems at baseline
Title
behavioral problems
Description
Neuropsychiatric Inventory-Questionnaire(NPI-Q)
Time Frame
behavioral problems after the completion of intervention
Title
behavioral problems
Description
Neuropsychiatric Inventory-Questionnaire(NPI-Q)
Time Frame
behavioral problems at 4 weeks after the completion of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Been diagnosed as mild to moderate dementia and CDR score between 0.5~2
can communicate in Chinese or Taiwanese
without visual or auditory impairment after equipping assist devices
Exclusion Criteria:
severe dementia and Clinical Dementia Rating (CDR) score more than 2 points
functional dependence
incapable of expressing their feelings
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui-Chuan Huang, PhD
Organizational Affiliation
School of Nursing, Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonghe Zhongxing Public Seniors Center
City
New Taipei City
ZIP/Postal Code
234
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ROMA (Reminiscence, Reality Orientation, Music and Art ) Therapy, Cognition, Depression and Behavioral Problems in the Population With Dementia
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