Effectiveness of Flash Mediation Therapy

NCT ID: NCT02933177

Last Updated: 2017-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 241 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-03-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

2 months control condition - 4 months chariot-flash

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.

Group Type: EXPERIMENTAL

2 months control condition - 4 months chariot-flash

Intervention Type: 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

200 patient, in 14 other nursing homes will be exposed 4 months in the control condition and 2 months in the experimental condition

Group Type: EXPERIMENTAL

4 months control condition-2 months chariot flash

Intervention Type: 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.

Interventions

2 months control condition - 4 months chariot-flash

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

4 months control condition-2 months chariot flash

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

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Krolak Salmon

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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

Lyon, , France

Countries

France

Other Identifiers

69HCL16_0442

Identifier Type: -

Identifier Source: org_study_id