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DementiaNCT04507633

ROMA (Reminiscence, Reality Orientation, Music and Art ) Therapy, Cognition, Depression and Behavioral Problems in the Population With Dementia

A study testing ROMA therapy(reminiacence therpy, orientation, music, and art) in people with Dementia, run by Taipei Medical University at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Dementia
What is being tested?
ROMA therapy(reminiacence therpy, orientation, music, and art)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteTaiwan
Study dates
25 Aug 2020to 31 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Yonghe Zhongxing Public Seniors Center

    New Taipei City, 234

Other trials in Taiwan

About this study

Official title: The Effect of ROMA Therapy on Improving Cognitive Functions, Depressive Symptoms and Behavioral Problems in the Population With Dementia

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.

Read the 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.

Conditions
Dementia
Being tested
ROMA therapy(reminiacence therpy, orientation, music, and art)
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ROMA therapy(reminiacence therpy, orientation, music, and art)Behavioural

    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.

Study groups in NCT04507633
Study groupRoleWhat they receive
ROMA therapyExperimentalROMA therapy combines four elements including reminiscence, reality orientation, music, and art in the intervention.
Receives: Behavioral: ROMA therapy(reminiacence therpy, orientation, music, and art)
control groupNo interventionusual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cognitive functions

    Short Portable Mental Status Questionnaire(SPMSQ)

    Measured: cognitive functions at baseline

  2. cognitive functions

    Short Portable Mental Status Questionnaire(SPMSQ)

    Measured: cognitive functions after the completion of intervention

  3. cognitive functions

    Short Portable Mental Status Questionnaire(SPMSQ)

    Measured: cognitive functions at 4 weeks after the completion of intervention

  4. depressive symptoms

    Cornell Scale for Depression in Dementia(CSDD)

    Measured: depressive symptoms at baseline

  5. depressive symptoms

    Cornell Scale for Depression in Dementia(CSDD)

    Measured: depressive symptoms after the completion of intervention

  6. depressive symptoms

    Cornell Scale for Depression in Dementia(CSDD)

    Measured: depressive symptoms at 4 weeks after the completion of intervention

  7. behavioral problems

    Neuropsychiatric Inventory-Questionnaire(NPI-Q)

    Measured: behavioral problems at baseline

  8. behavioral problems

    Neuropsychiatric Inventory-Questionnaire(NPI-Q)

    Measured: behavioral problems after the completion of intervention

  9. behavioral problems

    Neuropsychiatric Inventory-Questionnaire(NPI-Q)

    Measured: behavioral problems at 4 weeks after the completion of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2020
  2. Study start25 Aug 2020
  3. Primary completion30 Jul 2021
  4. Study completion31 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04507633
Sponsor's protocol ID
N202005108
Status last verified
Mar 2022
First submitted
25 Jul 2020
Last updated
21 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36495795

Questions about this trial

What is this clinical trial studying?

A study testing ROMA therapy(reminiacence therpy, orientation, music, and art) in people with Dementia, run by Taipei Medical University at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cognitive functions (time frame: cognitive functions at baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04507633, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.

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