NCT04507633

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

August 25, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

11 months

First QC Date

July 25, 2020

Last Update Submit

March 18, 2022

Conditions

Dementia

Outcome Measures

Primary Outcomes (9)

  • cognitive functions

    Short Portable Mental Status Questionnaire(SPMSQ)

    cognitive functions at baseline

  • cognitive functions

    Short Portable Mental Status Questionnaire(SPMSQ)

    cognitive functions after the completion of intervention

  • cognitive functions

    Short Portable Mental Status Questionnaire(SPMSQ)

    cognitive functions at 4 weeks after the completion of intervention

  • depressive symptoms

    Cornell Scale for Depression in Dementia(CSDD)

    depressive symptoms at baseline

  • depressive symptoms

    Cornell Scale for Depression in Dementia(CSDD)

    depressive symptoms after the completion of intervention

  • depressive symptoms

    Cornell Scale for Depression in Dementia(CSDD)

    depressive symptoms at 4 weeks after the completion of intervention

  • behavioral problems

    Neuropsychiatric Inventory-Questionnaire(NPI-Q)

    behavioral problems at baseline

  • behavioral problems

    Neuropsychiatric Inventory-Questionnaire(NPI-Q)

    behavioral problems after the completion of intervention

  • behavioral problems

    Neuropsychiatric Inventory-Questionnaire(NPI-Q)

    behavioral problems at 4 weeks after the completion of intervention

Study Arms (2)

ROMA therapy

EXPERIMENTAL

ROMA therapy combines four elements including reminiscence, reality orientation, music, and art in the intervention.

Behavioral: ROMA therapy(reminiacence therpy, orientation, music, and art)

control group

NO INTERVENTION

usual care

Interventions

ROMA therapy(reminiacence therpy, orientation, music, and art)BEHAVIORAL

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.

ROMA therapy

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • severe dementia and Clinical Dementia Rating (CDR) score more than 2 points
  • functional dependence
  • incapable of expressing their feelings

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonghe Zhongxing Public Seniors Center

New Taipei City, 234, Taiwan

Location

Related Publications (1)

  • Tz-Han L, Wan-Ru W, I-Hui C, Hui-Chuan H. Reminiscence music intervention on cognitive, depressive, and behavioral symptoms in older adults with dementia. Geriatr Nurs. 2023 Jan-Feb;49:127-132. doi: 10.1016/j.gerinurse.2022.11.014. Epub 2022 Dec 8.

    PMID: 36495795DERIVED

MeSH Terms

Conditions

Dementia

Interventions

Reproductive Techniques, Assisted

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Reproductive TechniquesTherapeuticsInvestigative Techniques

Study Officials

  • Hui-Chuan Huang, PhD

    School of Nursing, Taipei Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
independent researchers will perform intervention and data collection.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 25, 2020

First Posted

August 11, 2020

Study Start

August 25, 2020

Primary Completion

July 30, 2021

Study Completion

July 31, 2021

Last Updated

March 21, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)