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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Intensive educative management | 5 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.