Back to resultsEffectiveness of Flash Mediation Therapy
Primary Purpose
Dementia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
2 months control condition - 4 months chariot-flash
4 months control condition-2 months chariot flash
Sponsored by
About this trial
This is an interventional health services research trial for Dementia focused on measuring Dementia, Alzheimer disease, Behavioral and Psychological Symptoms of Dementia, non-drug intervention
Eligibility Criteria
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
Sites / Locations
- Hôpital des Charpennes Centre de Recherche Clinique "Vieillissement-Cerveau-Fragilité"
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
2 months control condition - 4 months chariot-flash
4 months control condition-2 months chariot flash
Arm Description
200 patient , in 15 nursing homes randomly will be exposed two months in the control condition (usual intervention) and 4 months in the experimental condition (chariot-flash intervention). The experimental condition is to propose the "chariot-flash" in emergency during the emergence or increase of productive symptoms.
200 patient, in 14 other nursing homes will be exposed 4 months in the control condition and 2 months in the experimental condition
Outcomes
Primary Outcome Measures
Change in number of disorders
the number of disorders are evaluated with Cohen Mansfield Agitation Inventory (CMAI) before and 30 minutes after each intervention.
The original version of the CMAI is initially planned to study the frequency of these disorders. However, the goal being to study the decrease in productive symptoms, after using the "chariot-flash", only the number of this item will be considered (between 0 and 29). For example in this modified version, for the item "pace, aimless wandering" nursing team can answer "present" or "absent" instead of (never, less than once a week, once or twice per week, a few times over week, one to two times daily, several times a day, several times per hour)
Secondary Outcome Measures
Change in score of well-being
the score of well-being is assessed using the Instant Well-Being scale (Evaluation Instantané du Bien-Etre : EVIBE) before and 30 minutes after each intervention .
The EVIBE is a visual analogue scale for reporting the status of well-being of the patient at a specific time. On a graduated scale from 0 to 5, the caregiver should position a cursor position to the left corresponding to the feeling of well-being the lowest and the right position to the feeling of well-being the highest.
change in psychotropic drugs prescribed
The caregiver or doctor will check on a board what are the treatments that have been added or modified (compared to the usual treatment) in response to behavioral disorder
change in score of BPSD
the score of BPSD is assessed using the neuropsychiatric inventory nursing home version (NPI-NH).
Each of the 12 BPSD (delusions, hallucinations, agitation, depression, anxiety, excitement, apathy, disinhibition, depression, motor aberrant behavior, sleep and appetite) is evaluated on 12 depending on its frequency and severity (global score =144).
change in level of agitation
the level of agitation is assessed using the original version of CMAI. The CMAI lists 29 agitation and aggressive behaviors by frequency (0: not evaluable 1: never, 2: less than once a week 3 : once or twice per week, 4 : a few times over week, 5: one to two times daily, 6 : several times a day, 7 : several times per hour) to obtain a score ranging from 0-203.
change in the number of administered psychotropic drugs.
The caregiver or doctor will check on a board on which is written all psychotropic treatments that the patient takes and the dosage
The number of hospitalization
The caregiver or doctor will refer in a table the different hospitalizations during the study and their date
The number of fall
The caregiver or doctor will refer in a table the different falls during the study and their date.
Full Information
NCT ID
NCT02933177
First Posted
October 12, 2016
Last Updated
November 29, 2017
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT02933177
Brief Title
Effectiveness of Flash Mediation Therapy
Official Title
Study on Effectiveness of Flash Mediation Therapy in the Context of Acute Psychological and Behavioral Symptoms of Dementia in Nursing Homes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
5. Study Description
Brief Summary
In order to offer a non-drug intervention for caregivers in nursing home to respond promptly to a behavioral crisis with an appropriate response to each patient, a chariot has been developed by the Institute of Ageing Well Korian (Institut du Bien Vieillir Korian) to bring together eleven mediation activities. These activities lasting about 15 minutes are based on emotion (reminiscent, games) and sensory interventions (music, massage, touch) to decentralize patient stimulus that disturbs and focus on a subject not disruptive. This emergency intervention should provide a reduction in Behavioral and Psychological Symptom of Dementia (BPSD) of nursing home patients. The main objective is to measure its immediate effect on productive symptoms (agitation, aberrant motor behavior and disinhibition). The secondary objectives are to measure its immediate impact on the well-being and psychotropic treatments, and measure its effect after two months and after four months on all BPSD with a focus on agitation, the administration of psychotropic drugs, the hospitalizations and the number of falls.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Dementia, Alzheimer disease, Behavioral and Psychological Symptoms of Dementia, non-drug intervention
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
241 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2 months control condition - 4 months chariot-flash
Arm Type
Experimental
Arm Description
200 patient , in 15 nursing homes randomly will be exposed two months in the control condition (usual intervention) and 4 months in the experimental condition (chariot-flash intervention). The experimental condition is to propose the "chariot-flash" in emergency during the emergence or increase of productive symptoms.
Arm Title
4 months control condition-2 months chariot flash
Arm Type
Experimental
Arm Description
200 patient, in 14 other nursing homes will be exposed 4 months in the control condition and 2 months in the experimental condition
Intervention Type
Behavioral
Intervention Name(s)
2 months control condition - 4 months chariot-flash
Intervention Description
The control condition is to propose the usual procedures for the management of productive symptoms during the emergence or increase of these symptoms.
The "chariot-flash" condition is a chariot with eleven drawers. Each drawer contains an activity (lasting about 15 minutes):
Boards of known photographs to recall autobiographical memories
Newspapers to read, talk, associate memories around an article
Massage Oil, refreshing wipes, cream to reconnect with the body
Clay, cookie pieces, washable felt and paper to create shapes, draw.
Walk with a person of the healthcare team the case of behavioral disorders in type of ambulation and untimely exit .
Listening to music
Relaxation-Breathing
Cushion, foam balls to vent his energy on secure hardware.
Plush doll or to invest a vector object of affection and empathy
Sensory flash balls that the patient can squeeze, throw, roll.
Games with which the patient can play according to its possibilities.
Intervention Type
Behavioral
Intervention Name(s)
4 months control condition-2 months chariot flash
Intervention Description
The control condition is to propose the usual procedures for the management of productive symptoms during the emergence or increase of these symptoms.
The "chariot-flash" condition is a chariot with eleven drawers. Each drawer contains an activity (lasting about 15 minutes):
Boards of known photographs to recall autobiographical memories
Newspapers to read, talk, associate memories around an article
Massage Oil, refreshing wipes, cream to reconnect with the body
Clay, cookie pieces, washable felt and paper to create shapes, draw.
Walk with a person of the healthcare team the case of behavioral disorders in type of ambulation and untimely exit .
Listening to music
Relaxation-Breathing
Cushion, foam balls to vent his energy on secure hardware.
Plush doll or to invest a vector object of affection and empathy
Sensory flash balls that the patient can squeeze, throw, roll.
Games with which the patient can play according to its possibilities.
Primary Outcome Measure Information:
Title
Change in number of disorders
Description
the number of disorders are evaluated with Cohen Mansfield Agitation Inventory (CMAI) before and 30 minutes after each intervention.
The original version of the CMAI is initially planned to study the frequency of these disorders. However, the goal being to study the decrease in productive symptoms, after using the "chariot-flash", only the number of this item will be considered (between 0 and 29). For example in this modified version, for the item "pace, aimless wandering" nursing team can answer "present" or "absent" instead of (never, less than once a week, once or twice per week, a few times over week, one to two times daily, several times a day, several times per hour)
Time Frame
until 4 months
Secondary Outcome Measure Information:
Title
Change in score of well-being
Description
the score of well-being is assessed using the Instant Well-Being scale (Evaluation Instantané du Bien-Etre : EVIBE) before and 30 minutes after each intervention .
The EVIBE is a visual analogue scale for reporting the status of well-being of the patient at a specific time. On a graduated scale from 0 to 5, the caregiver should position a cursor position to the left corresponding to the feeling of well-being the lowest and the right position to the feeling of well-being the highest.
Time Frame
until 4 months
Title
change in psychotropic drugs prescribed
Description
The caregiver or doctor will check on a board what are the treatments that have been added or modified (compared to the usual treatment) in response to behavioral disorder
Time Frame
until 4 months
Title
change in score of BPSD
Description
the score of BPSD is assessed using the neuropsychiatric inventory nursing home version (NPI-NH).
Each of the 12 BPSD (delusions, hallucinations, agitation, depression, anxiety, excitement, apathy, disinhibition, depression, motor aberrant behavior, sleep and appetite) is evaluated on 12 depending on its frequency and severity (global score =144).
Time Frame
before the beginning of the study, at 2 months, 4 months and 6 months
Title
change in level of agitation
Description
the level of agitation is assessed using the original version of CMAI. The CMAI lists 29 agitation and aggressive behaviors by frequency (0: not evaluable 1: never, 2: less than once a week 3 : once or twice per week, 4 : a few times over week, 5: one to two times daily, 6 : several times a day, 7 : several times per hour) to obtain a score ranging from 0-203.
Time Frame
before the beginning of the study, at 2 months, 4 months and 6 months
Title
change in the number of administered psychotropic drugs.
Description
The caregiver or doctor will check on a board on which is written all psychotropic treatments that the patient takes and the dosage
Time Frame
before the beginning of the study, at 2 months, 4 months and 6 months
Title
The number of hospitalization
Description
The caregiver or doctor will refer in a table the different hospitalizations during the study and their date
Time Frame
at 2 months, 4 months and 6 months
Title
The number of fall
Description
The caregiver or doctor will refer in a table the different falls during the study and their date.
Time Frame
at 2 months, 4 months and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Krolak Salmon
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital des Charpennes Centre de Recherche Clinique "Vieillissement-Cerveau-Fragilité"
City
Lyon
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of Flash Mediation Therapy
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