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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02919748 |
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Date of registration:
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19/09/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Choral Singing For the Prevention of Dementia
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Scientific title:
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Choral Singing For the Prevention of Dementia: A Randomized Controlled Trial |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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360 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT02919748 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Singapore
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Contacts
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Name:
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Lei Feng, Medicine |
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Address:
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Telephone:
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Email:
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Affiliation:
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National University, Singapore |
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Name:
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Lei Feng, Medicine |
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Address:
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Telephone:
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65-67723491 |
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Email:
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pcmfl@nus.edu.sg |
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Affiliation:
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Name:
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Elisabeth Ow, Nursing |
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Address:
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Telephone:
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65-67910134 |
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Email:
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pcmokte@nus.edu.sg |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Community-living elderly aged 60 years and above, and
2. Subjective cognitive complaints based on self-report, or
3. Objective cognitive impairment based on neuropsychological test scores (Z score < 0
and >-1.5), or
4. Multiple risk factors of dementia such as family history, depression, etc., and
5. Not demented: Clinical Dementia Rating (CDR) global score=0
Exclusion Criteria:
1. Any terminal illness, OR
2. Stroke, OR
3. Aphasia, OR
4. Marked hearing impairment, OR
5. Participating in another interventional study
Age minimum:
60 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cognitive Decline
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Dementia
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Intervention(s)
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Other: Choral Singing
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Other: Health Education Program
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Primary Outcome(s)
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Changes in cognitive performance
[Time Frame: Baseline, 1 year, 2 year]
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Secondary Outcome(s)
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Changes in Rey Auditory Verbal Learning Test
[Time Frame: Baseline, 1 year, 2 year]
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Changes in Montreal Cognitive Assessment
[Time Frame: Baseline, 6 month, 1 year, 2 year]
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Changes in biological markers
[Time Frame: Baseline, 1 year, 2 year]
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Changes in Symbol Digit Modality
[Time Frame: Baseline, 1 year, 2 year]
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Anxiety symptoms
[Time Frame: Baseline, 6 month, 1 year, 2 year]
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Changes in Block Design
[Time Frame: Baseline, 1 year, 2 year]
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Changes in Boston Naming
[Time Frame: Baseline, 1 year, 2 year]
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Stress
[Time Frame: Baseline, 6 month, 1 year, 2 year]
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Changes in brain structure and function
[Time Frame: Baseline, 1 year, 2 year]
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Changes in Digit Span
[Time Frame: Baseline, 1 year, 2 year]
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Neuropsychiatric symptoms
[Time Frame: Baseline, 6 month, 1 year, 2 year.]
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Sleep quality
[Time Frame: Baseline, 6 month, 1 year, 2 year]
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Changes in Mini-Mental State Examination
[Time Frame: Baseline, 6 month, 1 year, 2 year]
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Depressive symptoms
[Time Frame: Baseline, 6 month, 1 year, 2 year]
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Changes in Color Trails
[Time Frame: Baseline, 1 year, 2 year]
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Severity of symptoms of dementia
[Time Frame: Baseline, 1 year, 2 year]
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Secondary ID(s)
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NUS-IRB: B-14-304
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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