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 (TDCHandi)

February 26, 2018 updated by: Assistance Publique - Hôpitaux de Paris
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
63

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Roche Guyon, France, 95780
        • Hôpital La Roche Guyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intensive educative program
5 hours a week
Behavioral: Intensive educative management
5 hours a week
Active Comparator: Usual practice of educative program
1 hour a week
Behavioral: Intensive educative management
5 hours a week

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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

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
At the inclusion and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Chronic pain. (EDSS scale)
Time Frame: At the inclusion, 6 months and 12 months.
Pain evaluation with the validated EDSS scale
At the inclusion, 6 months and 12 months.
Evolution of frequency of behavior disorders.
Time Frame: At the inclusion, 6 months and 12 months.
The behavioral disorders will be evaluated during 7 days with a form filled out twice a day by caregivers.
At the inclusion, 6 months and 12 months.
Consumption of psychotropic treatments.
Time Frame: At the inclusion and 12 months.
Reduction of the number and/or dose of psychotropic treatments.
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
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.
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
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
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
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
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
At the inclusion and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique - Hôpitaux de Paris

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Etienne GUILLUY, GUILLUY, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 27, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 27, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • K140701
  • PHRIP140325 (Other Identifier: Assistance publique)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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