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

NCT ID: NCT02510846

Last Updated: 2018-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-15
• Study Completion Date: 2017-07-27

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.

Detailed 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).

Conditions

Polyhandicap; Behavior Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intensive educative program

5 hours a week

Group Type: EXPERIMENTAL

Intensive educative management

Intervention Type: BEHAVIORAL

5 hours a week

Usual practice of educative program

1 hour a week

Group Type: ACTIVE_COMPARATOR

Intensive educative management

Intervention Type: BEHAVIORAL

5 hours a week

Interventions

Intensive educative management

5 hours a week

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Etienne GUILLUY, GUILLUY

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital La Roche Guyon

La Roche-Guyon, , France

Countries

France

Other Identifiers

PHRIP140325

Identifier Type: OTHER

Identifier Source: secondary_id

K140701

Identifier Type: -

Identifier Source: org_study_id