Impact of an Intensive Multimodal Educative Program on Behavioral Disorders of Patients With Profound Multiple Disabilities and on the Quality of Life and Feelings of Caregivers

NCT02510846 | Completed

• 2 other identifiers: K140701PHRIP140325
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Profound multiple disabilities also called in French polyhandicap are defined by the combination of a deep mental disability and severe motor deficit with extreme restriction of autonomy. Life in institution for people with profound multiple disabilities induces emotional and educative deficiency and often conducts to behavioral disorders. These behavioral disorders also impact on quality of life and feelings of caregivers. An intensive multimodal educative program proposed to patients with profound multiple disabilities can improve their psychic well-being, reduce chronic pain and improve also quality of life and feelings of caregivers. The intensive multimodal educative program will be compared to the usual practice of educative program.

Conditions

Polyhandicap; Behavior Disorders

Keywords

Polyhandicap; Behavior disorders; Educative program; Caregivers; Quality of life.

Outcome Measures

Primary Outcomes (1)

• To assess the efficacy at 12 months of intensive multimodalitaire educational care compared to usual educational care of patients with multiple disabilities on behavioral disorders.

  The average number of predominant behavioral disorder will be evaluated by caregivers filling a form twice a day during 7 days. The predominant behavioral disorder will be identified by the caregivers after 15 days of observation among the following disorders: * Restlessness episodes * Unexplained crying * Rumination * Bruxism * Self-mutilations * Heteroagressif behavior * Gestural Stereotypies * Rythmic movements (swings) * Iterative friction

  At the inclusion and 12 months

Secondary Outcomes (9)

• Chronic pain. (EDSS scale)

  At the inclusion, 6 months and 12 months.

• Evolution of frequency of behavior disorders.

  At the inclusion, 6 months and 12 months.

• Consumption of psychotropic treatments.

  At the inclusion and 12 months.

• Evaluation of the impact of an intensive educative program for patients on chronic stress consequences on referent caregivers at the inclusion, 6 months and 12 months evaluated by the Maslach Burnout Inventory (MBI).

  At the inclusion, 6 months and 12 months

• Evaluation of the impact of an intensive educative program for patients on implemented strategy to deal with stress among referent caregivers at the inclusion and 12 months. with the Brief-COPE questionnaire.

  At the inclusion and 12 months.

Study Arms (2)

Intensive educative program

EXPERIMENTAL

5 hours a week

Behavioral: Intensive educative management

Usual practice of educative program

ACTIVE COMPARATOR

1 hour a week

Behavioral: Intensive educative management

Interventions

Intensive educative management BEHAVIORAL

5 hours a week

Intensive educative program; Usual practice of educative program

Eligibility Criteria

• Age: 3 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Hospitalized patient
• Age between 3 and 35 years old
• Patient with multiple disabilities defined by the following 5 criteria:
• reached or causal brain injury occurred before 3 years and
• profound mental disability (IQ lower than 35 or not assessable by psychometric tests when patients are too deficient) and
• motor disability (para-quadraparesis, hemiparesis, diplegia, ataxia, extrapyramidal motor disorders, neuromuscular disorders) and
• reduced mobility ( Gross Motor Function Classification System score: GMFCS III à V) and
• extreme autonomy restriction (FMI Functional Independency lower than 50)
• Patient with at least once per week of the following behavioral disorders:
• Restlessness episodes (refusal of physical or verbal contact expressed by gestures aiming to push off other patients or caregivers and/or shouts when caregivers try to approach).
• Unexplained crying: according to the Riccilo S.C, Watterson T \[Riccilo 1984\] definition: fully or partially closed eyes, facial grim/wince and vocalization with or without tears.
• Rumination or
• Bruxism or
• Self-mutilations or
• Heteroagressif behavior (bite, pinch, hit) or

You may not qualify if:

• No agreement of participation to the study by the holders of parental authority / legal guardian.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital La Roche Guyon

La Roche-Guyon, 95780, France

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Etienne GUILLUY, GUILLUY

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: July 29, 2015
• Study Start: January 15, 2016
• Primary Completion: July 27, 2017
• Study Completion: July 27, 2017
• Last Updated: February 27, 2018

Record last verified: 2018-02

Locations

FR (1)