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WithdrawnNCT03438513TRAMPDUpdated May 11, 2021

Contribution of the Therapies of Resolution of Problem in the Care of the Natural Caregivers of Patients Affected by Neurodegenerative Disease Living at Home

An observational study in Neurodegenerative Diseases, sponsored by University Hospital, Montpellier. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-11.

Sponsored by University Hospital, Montpellier · Observational

Why this study was withdrawn
Still no inclusion 10 months after the implementation visit. The study is outdated. Since, there has been "Alzheimer Plan" and establishment of external structures identical to the research project.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Neurodegenerative Diseases

Keywords

  • Caregivers
  • Burden
  • Coping
  • Quality of life
  • Problem solving therapy
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Caregivers of patients affected by major neurocognitive disorder

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • Problem Solving Therapy

    This program is intended for caregivers to acquire techniques to manage stressful situations encountered in everyday life.

    Behavioral: Problem Solving Therapy

  • Speaking group

    The group will be led by a psychologist.

    Behavioral: Speaking group

  • Standard medical care

    Occupational Therapy Assessment Psychological assessment

    Behavioral: Occupational Therapy Assessment · Behavioral: Psychological Assessment

Interventions

  • BehavioralOccupational Therapy Assessment

    The occupational therapy assessment includes a functional evaluation of the disorders impact (activities of daily living)

  • BehavioralPsychological Assessment

    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.

  • BehavioralProblem Solving Therapy

    Problem-solving learning program for all situations of daily living, done in groups (10 people per group)

  • BehavioralSpeaking group

    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.

05

What researchers measure

Primary outcomes

  1. The evolution in 12 months of the burden of the caregivers estimated with the scale of burden of Zarit (ZBI)

    Compare the efficiency of one taken care based on the therapy of resolution of problème

    Time frame: 12 months after the inclusion

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03438513
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Feb 19, 2018
Start date
Jul 5, 2017
Primary completion
Jul 5, 2017
Completion
Jul 5, 2017
Last update
May 11, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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