DementiaNCT02933177
Effectiveness of Flash Mediation Therapy
A study of Dementia, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteFrance
- Study dates
- May 2016to Mar 2017
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Deafness or blindness may compromise patient assessment or participation in the intervention
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital des Charpennes Centre de Recherche Clinique "Vieillissement-Cerveau-Fragilité"
Lyon
About this study
Official title: Study on Effectiveness of Flash Mediation Therapy in the Context of Acute Psychological and Behavioral Symptoms of Dementia in Nursing Homes
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.
- Conditions
- Dementia
- Being tested
- 2 months control condition - 4 months chariot-flash, 4 months control condition-2 months chariot flash
- Keywords
- Dementia, Alzheimer disease, Behavioral and Psychological Symptoms of Dementia, non-drug intervention
- Medical subject headings
- Dementia, Alzheimer Disease, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 months control condition - 4 months chariot-flashBehavioural
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.
4 months control condition-2 months chariot flashBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 2 months control condition - 4 months chariot-flash | Experimental | 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. Receives: Behavioral: 2 months control condition - 4 months chariot-flash |
| 4 months control condition-2 months chariot flash | Experimental | 200 patient, in 14 other nursing homes will be exposed 4 months in the control condition and 2 months in the experimental condition Receives: Behavioral: 4 months control condition-2 months chariot flash |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: until 4 months
Secondary outcomes (7)
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.
Measured: until 4 months
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
Measured: until 4 months
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).
Measured: before the beginning of the study, at 2 months, 4 months and 6 months
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.
Measured: before the beginning of the study, at 2 months, 4 months and 6 months
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
Measured: before the beginning of the study, at 2 months, 4 months and 6 months
The number of hospitalization
The caregiver or doctor will refer in a table the different hospitalizations during the study and their date
Measured: at 2 months, 4 months and 6 months
The number of fall
The caregiver or doctor will refer in a table the different falls during the study and their date.
Measured: at 2 months, 4 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startMay 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Krolak Salmon, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933177
- Sponsor's protocol ID
- 69HCL16_0442
- Status last verified
- Aug 2017
- First submitted
- 12 Oct 2016
- Last updated
- 2 Dec 2017
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Effectiveness of Flash Mediation Therapy in the Context of Acute Psychological and Behavioral Symptoms of Dementia in Nursing Homes
- ClinicalTrials.gov ID
- NCT02933177
- Acronym / sponsor ID
- 69HCL16_0442
- Conditions
- Dementia
- Keywords
- Dementia, Alzheimer disease, Behavioral and Psychological Symptoms of Dementia, non-drug intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 14 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 months control condition - 4 months chariot-flash | Experimental | Behavioral: 2 months control condition - 4 months chariot-flash200 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. |
| 4 months control condition-2 months chariot flash | Experimental | Behavioral: 4 months control condition-2 months chariot flash200 patient, in 14 other nursing homes will be exposed 4 months in the control condition and 2 months in the experimental condition |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (1 listed)
- Deafness or blindness may compromise patient assessment or participation in the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2 months control condition - 4 months chariot-flashThe 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. | Behavioural | 2 months control condition - 4 months chariot-flash |
| 4 months control condition-2 months chariot flashThe 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. | Behavioural | 4 months control condition-2 months chariot flash |
Primary outcome
Change in number of disorders
Time frame: until 4 months
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)
7 secondary outcomes
Change in score of well-being
Time frame: until 4 months
change in psychotropic drugs prescribed
Time frame: until 4 months
change in score of BPSD
Time frame: before the beginning of the study, at 2 months, 4 months and 6 months
change in level of agitation
Time frame: before the beginning of the study, at 2 months, 4 months and 6 months
change in the number of administered psychotropic drugs.
Time frame: before the beginning of the study, at 2 months, 4 months and 6 months
The number of hospitalization
Time frame: at 2 months, 4 months and 6 months
The number of fall
Time frame: at 2 months, 4 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Krolak Salmon principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Dementia, run by Hospices Civils de Lyon at 1 site in France.
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 5 inclusion and 1 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 2 Dec 2017. 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 France. 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?
Change in number of disorders (time frame: until 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2017.