Effectiveness of Flash Mediation Therapy

NCT02933177 | Completed

• 1 other identifier: 69HCL16_0442
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

Dementia; Alzheimer disease; Behavioral and Psychological Symptoms of Dementia; non-drug intervention

Outcome Measures

Primary Outcomes (1)

• 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)

  until 4 months

Secondary Outcomes (7)

• Change in score of well-being

  until 4 months

• change in psychotropic drugs prescribed

  until 4 months

• change in score of BPSD

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

• change in level of agitation

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

• change in the number of administered psychotropic drugs.

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

Study Arms (2)

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.

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

Behavioral: 4 months control condition-2 months chariot flash

Interventions

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.

2 months control condition - 4 months chariot-flash

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.

4 months control condition-2 months chariot flash

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Deafness or blindness may compromise patient assessment or participation in the intervention

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Lyon, France

Location

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Behavior

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Study Officials

• Pierre Krolak Salmon

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 14, 2016
• Study Start: May 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: December 2, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)