- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03438513
Contribution of the Therapies of Resolution of Problem in the Care of the Natural Caregivers of Patients Affected by Neurodegenerative Disease Living at Home (TRAMPD)
The coverage of the caregivers of patients reached of neurodegenerative disease becomes essential. The psychic, physical but also social impacts for the caregivers are widely documented in the literature just like the stress associated with this role, we speak then about "burden of the caregivers". It seems that the caregivers set up little effective strategies of adaptation pulling fatal consequences on their well-being. He was shown in the literature, that a level of high stress is going to engender a decrease of mental flexibility and so entrainer a rigidity of adaptation.
To decrease the burden of the caregivers, numerous interventions were proposed. The analysis of the literature highlights that these interventions are rarely developed from theoretical models pulling(entailing) a stream of techniques proposed to the caregivers but without precise objective. The most effective interventions concerning the coverage(care) of the burden of the caregivers are the ones which are targeted and structured, those who put the helper in active position and who have an effect on the subjective burden. The cognitive-behavioral therapy (TCC) would seem particularly effective.
So, to modify the perception (collection) of the caregivers in front of cognitive, behavioral, functional modifications of their close friend(relation), to bring them to estimate positively their role and to favor the employment(use) of adaptive strategies turns out to be a privileged target of intervention to be used(employed) to improve the well-being of the caregivers and so decrease their burden.
Considering this, an intervention based on the techniques of resolution of problems (TRP) could show itself very relevant as specific coverage (care). The works concerning the contribution of the TRP and the adaptation generally concerning situations of health showed that this type(chap) of intervention facilitated an adapted situational coping, but also increased generally the social, academic and professional performances.
Various searches(researches) also showed that the resolution of problem is associated with indicators of adaptation at patients' nursing reached(affected) by Alzheimer's disease.
So we propose to the family caregivers a coverage(care) based on the therapy of resolution of problems taking support on the model of Lazarus's stress and Folkman and according to the model stemming from works of D' Zurilla and Nezu.
We make the hypothesis that this intervention is going to allow a decrease of the burden by allowing the caregivers to find a capacity to modulate their strategies to fit at best the evolutions of the clinical situation.
The main objective of our study is to compare the efficiency of a coverage(care) based on the Therapy of Resolution of Problems to a group of word and to that proposed at the moment within the pole of gerontology in the decrease of the burden of the caregivers of patients reached(affected) by neurodegenerative disease in 12 months. Our secondary objectives will concern the evolution of the burden in 6 months and the evolution of the strategies of coping, the anxious, depressive symptomatology, the quality of life, the mental flexibility in 6 and 12 months.
According to the data of the current literature, we expect a decrease of the psychological distress, an increase of the good(property) to be psychological. More specifically, by proposing an intervention targeted in particular at the management of the stress, the helper is going to acquire fitnesses which will have a long-lasting(sustainable) therapeutic effect.
By associating techniques of psychoeducation with techniques of management of the stress we hope we can propose a type(chap) of intervention suited to the natural caregivers to favor the preservation at home.
Study Overview
Status
Conditions
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
- caregivers of patients affected by major neurocognitive disorder (cognitive decline which compromises the independence of the person). The symptoms vary according to the type of symptom, (Diagnostic and Statistical Manual 5) according to the definition of the European charter of the family helper " nobody not professional who helps main title partly or totally for one person dependent on its circle of acquaintances for the activities of the everyday life. This help can be lavished in a permanent way or not and can take various forms
Exclusion criteria:
- Diagnosis of major depression or other psychiatric affections
- Participation to another program of intervention (help to the caregivers, taken care TCC)
- Adults protected by the law
- Loss of liberty by court or administrative order.
- Absence of signature of the informed consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Problem Solving Therapy
This program is intended for caregivers to acquire techniques to manage stressful situations encountered in everyday life.
|
Problem-solving learning program for all situations of daily living, done in groups (10 people per group)
|
Speaking group
The group will be led by a psychologist.
|
Intervention, carried out in groups (10 people per group) which will consist of sharing experiences, sufferings, exchange and allow people who attend to share their experiences.
|
Standard medical care
Occupational Therapy Assessment Psychological assessment
|
The occupational therapy assessment includes a functional evaluation of the disorders impact (activities of daily living)
It consists of a detailed history of the patient's experience, an evaluation with the patient (cognitive, emotional, motivational ...), an interview with the caregiver to see the repercussions of the disorders on a daily basis, how they are managed, and how they cope in order to give information and advice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The evolution in 12 months of the burden of the caregivers estimated with the scale of burden of Zarit (ZBI)
Time Frame: 12 months after the inclusion
|
Compare the efficiency of one taken care based on the therapy of resolution of problème
|
12 months after the inclusion
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9727
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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