Back to resultsImpact 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 (TDCHandi)
Primary Purpose
Polyhandicap, Behavior Disorders
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Intensive educative management
Sponsored by
About this trial
This is an interventional supportive care trial for Polyhandicap focused on measuring Polyhandicap, Behavior disorders, Educative program, Caregivers, Quality of life.
Eligibility Criteria
Inclusion Criteria:
- 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).
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.
Sites / Locations
- Hôpital La Roche Guyon
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intensive educative program
Usual practice of educative program
Arm Description
5 hours a week
1 hour a week
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Chronic pain. (EDSS scale)
Pain evaluation with the validated EDSS scale
Evolution of frequency of behavior disorders.
The behavioral disorders will be evaluated during 7 days with a form filled out twice a day by caregivers.
Consumption of psychotropic treatments.
Reduction of the number and/or dose of psychotropic treatments.
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).
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.
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).
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.
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
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
The most pervasive disorder is defined as the most harmful disorder for the patient and/or its management, according to the care teams responsible for each patient
Full Information
NCT ID
NCT02510846
First Posted
July 13, 2015
Last Updated
February 26, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT02510846
Brief 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
Acronym
TDCHandi
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 15, 2016 (Actual)
Primary Completion Date
July 27, 2017 (Actual)
Study Completion Date
July 27, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyhandicap, Behavior Disorders
Keywords
Polyhandicap, Behavior disorders, Educative program, Caregivers, Quality of life.
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intensive educative program
Arm Type
Experimental
Arm Description
5 hours a week
Arm Title
Usual practice of educative program
Arm Type
Active Comparator
Arm Description
1 hour a week
Intervention Type
Behavioral
Intervention Name(s)
Intensive educative management
Intervention Description
5 hours a week
Primary Outcome Measure Information:
Title
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.
Description
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
Time Frame
At the inclusion and 12 months
Secondary Outcome Measure Information:
Title
Chronic pain. (EDSS scale)
Description
Pain evaluation with the validated EDSS scale
Time Frame
At the inclusion, 6 months and 12 months.
Title
Evolution of frequency of behavior disorders.
Description
The behavioral disorders will be evaluated during 7 days with a form filled out twice a day by caregivers.
Time Frame
At the inclusion, 6 months and 12 months.
Title
Consumption of psychotropic treatments.
Description
Reduction of the number and/or dose of psychotropic treatments.
Time Frame
At the inclusion and 12 months.
Title
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
Title
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.
Title
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
Title
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
Title
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
Title
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
Description
The most pervasive disorder is defined as the most harmful disorder for the patient and/or its management, according to the care teams responsible for each patient
Time Frame
At the inclusion and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Etienne GUILLUY, GUILLUY
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital La Roche Guyon
City
La Roche Guyon
ZIP/Postal Code
95780
Country
France
12. IPD Sharing Statement
Learn more about this trial
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
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