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Completed

NCT Number: NCT02933177

Effectiveness of Flash Mediation Therapy

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.

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Key information

Conditions

Dementia Alzheimer Disease Behavior Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital des Charpennes Centre de Recherche Clinique "Vieillissement-Cerveau-Fragilité"

Lyon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2 months control condition - 4 months chariot-flash

Behavioral

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 flash

Behavioral

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 outcomes

  1. 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)

Secondary outcomes

  1. Change in score of well-being

    Time frame: until 4 months

    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.

  2. change in psychotropic drugs prescribed

    Time frame: until 4 months

    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

  3. change in score of BPSD

    Time frame: before the beginning of the study, at 2 months, 4 months and 6 months

    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).

  4. change in level of agitation

    Time frame: before the beginning of the study, at 2 months, 4 months and 6 months

    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.

  5. 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 caregiver or doctor will check on a board on which is written all psychotropic treatments that the patient takes and the dosage

  6. The number of hospitalization

    Time frame: at 2 months, 4 months and 6 months

    The caregiver or doctor will refer in a table the different hospitalizations during the study and their date

  7. The number of fall

    Time frame: at 2 months, 4 months and 6 months

    The caregiver or doctor will refer in a table the different falls during the study and their date.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Study on Effectiveness of Flash Mediation Therapy in the Context of Acute Psychological and Behavioral Symptoms of Dementia in Nursing Homes

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 14, 2016
Registry last updated
Dec 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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