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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
- Conditions
- Neurodegenerative Diseases
- 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 group | Role | What they receive |
|---|---|---|
| Problem Solving Therapy | This program is intended for caregivers to acquire techniques to manage stressful situations encountered in everyday life. Receives: Behavioral: Problem Solving Therapy | |
| Speaking group | The group will be led by a psychologist. Receives: Behavioral: Speaking group | |
| Standard medical care | Occupational 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.
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.
- First posted19 Feb 2018
- Study start5 Jul 2017
- Primary completion5 Jul 2017
- 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
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodegenerative DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of the Therapies of Resolution of Problem in the Care of the Natural Caregivers of Patients Affected by Neurodegenerative Disease Living at Home
- ClinicalTrials.gov ID
- NCT03438513
- Acronym / sponsor ID
- TRAMPD / 9727
- Conditions
- Neurodegenerative Diseases
- Keywords
- Caregivers, Burden, Coping, Quality of life, Problem solving therapy
- Study type
- Observational
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- 5 Jul 2017 (actual)
- Study completion
- 5 Jul 2017 (actual)
- First posted
- 19 Feb 2018 (actual)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Problem Solving Therapy | – | Behavioral: Problem Solving TherapyThis program is intended for caregivers to acquire techniques to manage stressful situations encountered in everyday life. |
| Speaking group | – | Behavioral: Speaking groupThe group will be led by a psychologist. |
| Standard medical care | – | Behavioral: Occupational Therapy Assessment, Behavioral: Psychological AssessmentOccupational Therapy Assessment Psychological assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Caregivers of patients affected by major neurocognitive disorder
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Occupational Therapy AssessmentThe occupational therapy assessment includes a functional evaluation of the disorders impact (activities of daily living) | Behavioural | Standard medical care |
| Psychological AssessmentIt 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. | Behavioural | Standard medical care |
| Problem Solving TherapyProblem-solving learning program for all situations of daily living, done in groups (10 people per group) | Behavioural | Problem Solving Therapy |
| Speaking groupIntervention, 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. | Behavioural | Speaking group |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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.