PolyhandicapTDCHandiNCT02510846
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
A study testing Intensive educative management in people with Polyhandicap and Behavior Disorders, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 35 years
- Conditions the study is for
- Polyhandicap, Behavior Disorders
- What is being tested?
- Intensive educative management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2016to 27 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 20Show fewer
- 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
Who cannot join
- No agreement of participation to the study by the holders of parental authority / legal guardian.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Intensive educative management
- Keywords
- Polyhandicap, Behavior disorders, Educative program, Caregivers, Quality of life.
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive educative managementBehavioural
5 hours a week
| Study group | Role | What they receive |
|---|---|---|
| Intensive educative program | Experimental | 5 hours a week Receives: Behavioral: Intensive educative management |
| Usual practice of educative program | Active comparator | 1 hour a week Receives: Behavioral: Intensive educative management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the inclusion and 12 months
Secondary outcomes (9)
Chronic pain. (EDSS scale)
Pain evaluation with the validated EDSS scale
Measured: At the inclusion, 6 months and 12 months.
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.
Measured: At the inclusion, 6 months and 12 months.
Consumption of psychotropic treatments.
Reduction of the number and/or dose of psychotropic treatments.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
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
Measured: At the inclusion and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study start15 Jan 2016
- Primary completion27 Jul 2017
- Study completion27 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolyhandicapStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etienne GUILLUY, GUILLUY, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510846
- Sponsor's protocol ID
- K140701
- Other IDs
- PHRIP140325
- Acronym
- TDCHandi
- Status last verified
- Feb 2018
- First submitted
- 13 Jul 2015
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02510846
- Acronym / sponsor ID
- TDCHandi / K140701
- Conditions
- Polyhandicap, Behavior Disorders
- Keywords
- Polyhandicap, Behavior disorders, Educative program, Caregivers, Quality of life.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 15 Jan 2016 (actual)
- Primary completion
- 27 Jul 2017 (actual)
- Study completion
- 27 Jul 2017 (actual)
- First posted
- 29 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive educative program | Experimental | Behavioral: Intensive educative management5 hours a week |
| Usual practice of educative program | Active comparator | Behavioral: Intensive educative management1 hour a week |
Who may qualify
- Ages
- 3 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (20 listed)
- Hospitalized patient
- Age between 3 and 35 years old
- Patient with multiple disabilities defined by the following 5 criteria:
- Patient with at least once per week of the following behavioral disorders:
- or
Key exclusion criteria (1 listed)
- No agreement of participation to the study by the holders of parental authority / legal guardian.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive educative management5 hours a week | Behavioural | Intensive educative program, Usual practice of educative program |
Primary outcome
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
9 secondary outcomes
Chronic pain. (EDSS scale)
Time frame: At the inclusion, 6 months and 12 months.
Evolution of frequency of behavior disorders.
Time frame: At the inclusion, 6 months and 12 months.
Consumption of psychotropic treatments.
Time frame: 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
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.
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etienne GUILLUY, GUILLUY principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive educative management in people with Polyhandicap and Behavior Disorders, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2018.