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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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16 December 2017 |
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Main ID: |
NCT02933177 |
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Date of registration:
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12/10/2016 |
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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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Effectiveness of Flash Mediation Therapy
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Scientific title:
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Study on Effectiveness of Flash Mediation Therapy in the Context of Acute Psychological and Behavioral Symptoms of Dementia in Nursing Homes |
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Date of first enrolment:
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May 2016 |
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Target sample size:
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241 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02933177 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Pierre Krolak Salmon |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospices Civils de Lyon |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- People ability to object and does not oppose either by themselves or through a trusted
person referred to in Article L. 1111-6 of the Code of Public Health, failing thereof,
by the family, or, if a person talking to the person close and stable ties. For adults
under guardianship, permission must be given by the legal representative of the
person. The research will benefit from the backing of Persons Protection Committee
(PPC) prior to its implementation;
- Man or woman over 60 years;
- patient living in one of the nursing homes participating in the project;
- Patient completing the diagnostic criteria for major neurocognitive disorder according
to Diagnostic and Statistical Manual of Mental Disorders V criteria (DSM-V)
- The patient must have at least one of these productive symptoms (agitation, aberrant
motor behavior, disinhibition) listed by the NPI-NH (score> 2 at least one of these
items)
Exclusion Criteria:
- Deafness or blindness may compromise patient assessment or participation in the
intervention
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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Dementia
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Intervention(s)
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Behavioral: 4 months control condition-2 months chariot flash
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Behavioral: 2 months control condition - 4 months chariot-flash
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Primary Outcome(s)
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Change in number of disorders
[Time Frame: until 4 months]
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Secondary Outcome(s)
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change in the number of administered psychotropic drugs.
[Time Frame: before the beginning of the study, at 2 months, 4 months and 6 months]
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Change in score of well-being
[Time Frame: until 4 months]
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The number of hospitalization
[Time Frame: at 2 months, 4 months and 6 months]
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change in psychotropic drugs prescribed
[Time Frame: until 4 months]
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change in level of agitation
[Time Frame: before the beginning of the study, at 2 months, 4 months and 6 months]
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change in score of BPSD
[Time Frame: before the beginning of the study, at 2 months, 4 months and 6 months]
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The number of fall
[Time Frame: at 2 months, 4 months and 6 months]
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Secondary ID(s)
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69HCL16_0442
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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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