Overview

This trial is active, not recruiting.

Conditions polyhandicap, behavior disorders
Treatment intensive educative management
Sponsor Assistance Publique - Hôpitaux de Paris
Start date January 2016
End date July 2017
Trial size 64 participants
Trial identifier NCT02510846, K140701, PHRIP140325

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
5 hours a week
intensive educative management
5 hours a week
(Active Comparator)
1 hour a week
intensive educative management
5 hours a week

Primary Outcomes

Measure
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.
time frame: At the inclusion and 12 months

Secondary Outcomes

Measure
Chronic pain. (EDSS scale)
time frame: At the inclusion, 6 months and 12 months.
Evolution of frequency of behavior disorders.
time frame: At the inclusion, 6 months and 12 months.
Consumption of psychotropic treatments.
time frame: 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).
time frame: 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.
time frame: At the inclusion and 12 months.
Evaluation of the impact of an intensive educative program for patients on emotional distress of referent caregivers evaluated at the inclusion and 12 months with the Hospital Anxiety and Depression Scale (HADS).
time frame: At the inclusion and 12 months
Evaluation of the impact of an intensive educative program for patients on quality of life of referent caregivers evaluated at the inclusion and 12 months with the WOQOL-Bref scale.
time frame: At the inclusion and 12 months
Evaluation of the impact an intensive educative program on the duration of behavioural problems by the average difference between the inclusion and at 12 months
time frame: At the inclusion and 12 months
Evaluation of the impact an intensive educative program on the disorder most invasive behaviour for the patient by the frequency of disappearance between the inclusion and at 12 months and the most pervasive disorder
time frame: At the inclusion and 12 months

Eligibility Criteria

Male or female participants from 3 years up to 35 years old.

Inclusion Criteria: - Hospitalized patient - Age between 3 and 35 years old - Patient with multiple disabilities defined by the following 5 criteria: 1. reached or causal brain injury occurred before 3 years and 2. profound mental disability (IQ lower than 35 or not assessable by psychometric tests when patients are too deficient) and 3. motor disability (para-quadraparesis, hemiparesis, diplegia, ataxia, extrapyramidal motor disorders, neuromuscular disorders) and 4. reduced mobility ( Gross Motor Function Classification System score: GMFCS III à V) and 5. 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). or • 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. or - Rumination or - Bruxism or - Self-mutilations or - Heteroagressif behavior (bite, pinch, hit) or - Gestural stereotypies or - Rythmic movements or - Iterative frictions Exclusion Criteria: - No agreement of participation to the study by the holders of parental authority / legal guardian.

Additional Information

Official title 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
Principal investigator Etienne GUILLUY, GUILLUY
Description People with profound multiples disabilities needs particular follow-up with education, care, communication and socialization. Our hypothesis is that an intensive multimodal educative program of 5 hours a week during 12 months compared to the usual practice of 1 hour a week conducts to the reduction of behavioral disorders and improves the quality of life and feelings of caregivers. This study is multicenter, controlled, randomized in two parallel groups and open-labelled comparing usual practice of educative program and intensive educative program during 12 months. The evolution of predominant behavioral disorder and quality of life and feelings of caregivers is evaluated at inclusion (M0), six months after (M6) and twelve months after (M12).
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.