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Neurodegenerative DiseasesTRAMPDNCT03438513

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 of Neurodegenerative Diseases, run by University Hospital, Montpellier.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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". Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neurodegenerative Diseases
What is being tested?
Occupational Therapy Assessment, Psychological Assessment and Problem Solving Therapy
How many people
0 participants
Where
No sites listed yet
Study dates
5 Jul 2017to 5 Jul 2017
Phase
Observational
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Caregivers of patients affected by major neurocognitive disorder

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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.

Read more

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.

Being tested
Occupational Therapy Assessment, Psychological Assessment, Problem Solving Therapy, Speaking group
Keywords
Caregivers, Burden, Coping, Quality of life, Problem solving therapy
Medical subject headings
Neurodegenerative Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Occupational Therapy AssessmentBehavioural

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

  • Psychological AssessmentBehavioural

    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.

  • Problem Solving TherapyBehavioural

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

  • Speaking groupBehavioural

    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.

Study groups in NCT03438513
Study groupRoleWhat they receive
Problem Solving TherapyThis program is intended for caregivers to acquire techniques to manage stressful situations encountered in everyday life.
Receives: Behavioral: Problem Solving Therapy
Speaking groupThe group will be led by a psychologist.
Receives: Behavioral: Speaking group
Standard medical careOccupational Therapy Assessment Psychological assessment
Receives: Behavioral: Occupational Therapy Assessment; Behavioral: Psychological Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months after the inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2018
  2. Study start5 Jul 2017
  3. Primary completion5 Jul 2017
  4. Study completion5 Jul 2017

Why it stopped: 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03438513
Sponsor's protocol ID
9727
Acronym
TRAMPD
Status last verified
May 2021
First submitted
5 Feb 2018
Last updated
11 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Neurodegenerative Diseases, run by University Hospital, Montpellier.

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 1 inclusion and 5 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: withdrawn, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

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). 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 11 May 2021.

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