Clinical Trials Directory

Trials / Completed

CompletedNCT02510846

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
63 (actual)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
3 Years – 35 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALIntensive educative management5 hours a week

Timeline

Start date
2016-01-15
Primary completion
2017-07-27
Completion
2017-07-27
First posted
2015-07-29
Last updated
2018-02-27

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02510846. Inclusion in this directory is not an endorsement.

Impact of an Intensive Multimodal Educative Program on Behavioral Disorders of Patients With Profound Multiple Disabilit (NCT02510846) · Clinical Trials Directory