Back to resultsEvaluation of the Effectiveness of the Parkinson Specialized Teams Intervention (ES-Park)
Primary Purpose
Parkinson Disease
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ESPark Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Parkinson Disease focused on measuring Parkinson, Quality of life, Complementary non drug intervention, Multidisciplinary approach
Eligibility Criteria
Inclusion Criteria:
For the patient:
- Patient with a diagnosis of idiopathic Parkinson's disease
- Patient over 18 years ;
- Patient with a Hoehn and Yahr Stage greater than or equal to 3;
- Patient without major cognitive impairment defined by a MOCA score ≥21
- Patient living at home ;
- Patient with an identified non-professional primary caregiver;
- Person affiliated with or benefiting from a social security plan;
- Free, informed and and express consent (confirmed in writing) (no later than the day of inclusion and before any examination required by the research).
For the caregiver:
- Male or female over 18 years
- Able to respond to research interviews/questionnaires
- Free, informed and express consent (confirmed in writing) (no later than the day of inclusion and before any examination required by the research).
Exclusion Criteria:
For the patient:
- Patient with medically indicated dementia impairing comprehension and adherence, and/or with severe confusion or psycho-hallucinatory state;
- Institutionalized or foster care patients;
- Patients with a known severe and unstable general pathology that does not allow for patient follow-up;
- Patients already included in another non-drug management trial;
- Patients whose institutionalization is envisaged in the short term (within 6 months) or for whom a change of residence is envisaged in the short term and would not allow for follow-up assessments;
- Patients under guardianship or unable to express consent
- Primary caregiver not wishing to participate in the study or unable to be available for the planned study follow-up;
- Presence of a primary caregiver with a known severe and unstable disease that does not allow for the conduct of the study;
- Presence of a primary caregiver with a known cognitive or psychiatric disorder (chronic progressive psychosis) that does not allow for the proper conduct of the study.
- Pregnant or breastfeeding woman.
For the caregiver:
- Unable to follow the research interviews or questionnaires.
- Primary caregiver not wishing to participate in the study or unable to be available for the planned study follow-up;
- Primary caregiver with a known severe and unstable illness that does not allow for the proper conduct of the study;
- Primary caregiver with known cognitive or psychiatric disorders (chronic progressive psychosis) that do not allow the study to be conducted properly.
Sites / Locations
- Hopital PellegrinRecruiting
- CHU de Limoges
- CHU Poitiers
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard care
ESPark Intervention
Arm Description
Under medical prescription and in addition to medical and physiotherapy care, the ESPark will intervene in an ecological way with Parkinson's patients in order to rehabilitate them, maintain their autonomy in their daily life and their social life with the aim of improving the quality of life of the patient and his main caregiver. Beyond a rehabilitative intervention in the home, the ESPark's mission would also be to optimize the patient's living environment and possibly help with the implementation of the necessary aids in the continuity of medical care.
Outcomes
Primary Outcome Measures
Score of quality of life scale (PDQ 39)
Self-questionnaire in 39 items evaluating the quality of life of Parkinson's patients from a motor and psychological point of view. Each question is rated from 0 (no disturbance) to 4 (maximum disturbance). The items are divided into 8 dimensions (activity of daily living, emotional well-being, psychological discomfort, social support, cognitive impairment, communication, physical discomfort, mobility) It consists of 39 items with a total score that varies from 0 to 154
Score of quality of life scale (PDQ 39)
Self-questionnaire in 39 items evaluating the quality of life of Parkinson's patients from a motor and psychological point of view. Each question is rated from 0 (no disturbance) to 4 (maximum disturbance). The items are divided into 8 dimensions (activity of daily living, emotional well-being, psychological discomfort, social support, cognitive impairment, communication, physical discomfort, mobility) It consists of 39 items with a total score that varies from 0 to 154
Secondary Outcome Measures
IADL assessment
Assessment of the level of dependence in instrumental activities of daily living It consists of 9 items with a total score that varies from 0 to 36 Each item is scored from 0 (autonom) to 4 (no autonom) or NA
IADL assessment
Assessment of the level of dependence in instrumental activities of daily living
IADL assessment
Assessment of the level of dependence in instrumental activities of daily living
Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Rate
Used to evaluate the various motor and non-motor symptoms. In this protocol, only motor examination will be carried out. This part includes the following items: speech, facial expression, rigidity, finger tapping, hand movements, hand pronation supination movements, toe tapping, leg agility, getting up from the examination chair, walking, postural stability, posture, overall spontaneity of movement, postural hand tremor, hand action tremor, amplitude of resting tremor, constancy of resting tremor. The items of the Parkinsonian triad are evaluated on the different parts of the body (extremities of the limbs, lip and jaw for resting tremor and neck for rigidity). The presence of dyskinesias is mentioned at the end of the evaluation and if they interfered with the motor examination, as well as the global scale of Hoehn and Yahr. All items are rated from 0 to 4 and are clearly defined : 0: normal, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe
Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Rate
Used to evaluate the various motor and non-motor symptoms. In this protocol, only motor examination will be carried out. This part includes the following items: speech, facial expression, rigidity, finger tapping, hand movements, hand pronation supination movements, toe tapping, leg agility, getting up from the examination chair, walking, postural stability, posture, overall spontaneity of movement, postural hand tremor, hand action tremor, amplitude of resting tremor, constancy of resting tremor. The items of the Parkinsonian triad are evaluated on the different parts of the body (extremities of the limbs, lip and jaw for resting tremor and neck for rigidity). The presence of dyskinesias is mentioned at the end of the evaluation and if they interfered with the motor examination, as well as the global scale of Hoehn and Yahr. All items are rated from 0 to 4 and are clearly defined : 0: normal, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe
Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Rate
Used to evaluate the various motor and non-motor symptoms. In this protocol, only motor examination will be carried out. This part includes the following items: speech, facial expression, rigidity, finger tapping, hand movements, hand pronation supination movements, toe tapping, leg agility, getting up from the examination chair, walking, postural stability, posture, overall spontaneity of movement, postural hand tremor, hand action tremor, amplitude of resting tremor, constancy of resting tremor. The items of the Parkinsonian triad are evaluated on the different parts of the body (extremities of the limbs, lip and jaw for resting tremor and neck for rigidity). The presence of dyskinesias is mentioned at the end of the evaluation and if they interfered with the motor examination, as well as the global scale of Hoehn and Yahr. All items are rated from 0 to 4 and are clearly defined : 0: normal, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe
Non-motor symptoms Scale for Parkinson's Disease (NMSS)
30-item scale that assesses a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The NMSS measures the severity and frequency of non-motor symptoms across nine dimensions. The scale can be used for patients in all stages of PD.
Non-motor symptoms Scale for Parkinson's Disease (NMSS)
30-item scale that assesses a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The NMSS measures the severity and frequency of non-motor symptoms across nine dimensions. The scale can be used for patients in all stages of PD.
Non-motor symptoms Scale for Parkinson's Disease (NMSS) score
30-item scale that assesses a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The NMSS measures the severity and frequency of non-motor symptoms across nine dimensions. The scale can be used for patients in all stages of PD.
Montreal Cognitive Assessment (MOCA) score
The MoCA assesses mild cognitive dysfunction. It assesses the following functions: short-term memory, visual-spatial skills, executive functions, attention, concentration, working memory, language, abstraction, calculation and orientation in time and space. Cognitive impairment is assessed using a 30-point score (27-30: no cognitive impairment; 18-26: mild; 10-17: moderate; < 10: severe).
Montreal Cognitive Assessment (MOCA) score
The MoCA assesses mild cognitive dysfunction. It assesses the following functions: short-term memory, visual-spatial skills, executive functions, attention, concentration, working memory, language, abstraction, calculation and orientation in time and space. Cognitive impairment is assessed using a 30-point score (27-30: no cognitive impairment; 18-26: mild; 10-17: moderate; < 10: severe).
Montreal Cognitive Assessment (MOCA) score
The MoCA assesses mild cognitive dysfunction. It assesses the following functions: short-term memory, visual-spatial skills, executive functions, attention, concentration, working memory, language, abstraction, calculation and orientation in time and space. Cognitive impairment is assessed using a 30-point score (27-30: no cognitive impairment; 18-26: mild; 10-17: moderate; < 10: severe).
Beck Depression Inventory (BDI-II) score
Self-questionnaire comprising a list of 21 items measuring the somatic, affective and cognitive severity of depressive symptoms. Each item is rated for symptom severity and/or frequency, over the past 7 days, on a 4-point scale ranging from 0 to 3. Higher scores indicate severe symptomatology.
Beck Depression Inventory (BDI-II) score
Self-questionnaire comprising a list of 21 items measuring the somatic, affective and cognitive severity of depressive symptoms. Each item is rated for symptom severity and/or frequency, over the past 7 days, on a 4-point scale ranging from 0 to 3. Higher scores indicate severe symptomatology.
Beck Depression Inventory (BDI-II) score
Self-questionnaire comprising a list of 21 items measuring the somatic, affective and cognitive severity of depressive symptoms. Each item is rated for symptom severity and/or frequency, over the past 7 days, on a 4-point scale ranging from 0 to 3. Higher scores indicate severe symptomatology.
Parkinson Anxiety Scale (PAS) Score
Self-questionnaire assessing anxiety in Parkinson's disease dealing with several dimensions of anxiety: Persistent anxiety (5 items), Episodic anxiety (4 items), Avoidance behavior (3 items). Each item is scored from 0 (not at all) to 4 (strongly or almost always).
Parkinson Anxiety Scale (PAS) Score
Self-questionnaire assessing anxiety in Parkinson's disease dealing with several dimensions of anxiety: Persistent anxiety (5 items), Episodic anxiety (4 items), Avoidance behavior (3 items). Each item is scored from 0 (not at all) to 4 (strongly or almost always).
Parkinson Anxiety Scale (PAS) Score
Self-questionnaire assessing anxiety in Parkinson's disease dealing with several dimensions of anxiety: Persistent anxiety (5 items), Episodic anxiety (4 items), Avoidance behavior (3 items). Each item is scored from 0 (not at all) to 4 (strongly or almost always).
Reduced Neuropsychiatric Inventory (NPI-R) score
Used to assesses 12 domains of psychobehavioral disorders (21). It is a questionnaire consisting of a screening question and seven to nine items for each of the 12 domains: delusions, hallucinations, agitation/aggressiveness, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor aberration, behavioural disorders, sleep, appetite and eating. The score ranges from 0 to 144 .
Reduced Neuropsychiatric Inventory (NPI-R) score
Used to assesses 12 domains of psychobehavioral disorders (21). It is a questionnaire consisting of a screening question and seven to nine items for each of the 12 domains: delusions, hallucinations, agitation/aggressiveness, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor aberration, behavioural disorders, sleep, appetite and eating. The score ranges from 0 to 144 .
Reduced Neuropsychiatric Inventory (NPI-R) score
Used to assesses 12 domains of psychobehavioral disorders. It is a questionnaire consisting of a screening question and seven to nine items for each of the 12 domains: delusions, hallucinations, agitation/aggressiveness, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor aberration, behavioural disorders, sleep, appetite and eating. The score ranges from 0 to 144 .
Zarit scale score
This scale assesses caregiver burden ; it consists of 22 items with a total score that varies from 0 to 88. (score ≤20, no burden - score> 60, severe burden).
Zarit scale score
This scale assesses caregiver burden ; it consists of 22 items with a total score that varies from 0 to 88. (score ≤20, no burden - score> 60, severe burden).
Zarit scale score
This scale assesses caregiver burden ; it consists of 22 items with a total score that varies from 0 to 88. (score ≤20, no burden - score> 60, severe burden).
State Trait Anxiety Inventory short scale (STAI-E and STAI-T) score
This anxiety scale consists of 2 scales of 20 questions that assess how subjects feel at the time and generally.
State Trait Anxiety Inventory short scale (STAI-E and STAI-T) score
This anxiety scale consists of 2 scales of 20 questions that assess how subjects feel at the time and generally.
State Trait Anxiety Inventory short scale (STAI-E and STAI-T) score
This anxiety scale consists of 2 scales of 20 questions that assess how subjects feel at the time and generally.
Quality of life as measured by the PQoL Carers.
Quality of life questionnaire for caregivers Self-questionnaire comprising a list of 26 items with a total score that varies from 0 to 104
Quality of life as measured by the PQoL Carers.
Quality of life questionnaire for caregivers Self-questionnaire comprising a list of 26 items with a total score that varies from 0 to 104
Quality of life as measured by the PQoL Carers.
Quality of life questionnaire for caregivers Self-questionnaire comprising a list of 26 items with a total score that varies from 0 to 104
Sense of competence questionnaire
This 35-item questionnaire covers three areas: the impact of caregiving on the caregiver's personal life, satisfaction with one's own performance as a caregiver, and satisfaction with the person with dementia as a recipient of care Each item is scored from 1 ("yes") to 3 ("No") and 2 (Yes/no) The total score varies from 27 to 81
Sense of competence questionnaire
This 35-item questionnaire covers three areas: the impact of caregiving on the caregiver's personal life, satisfaction with one's own performance as a caregiver, and satisfaction with the person with dementia as a recipient of care Each item is scored from 1 ("yes") to 3 ("No") and 2 (Yes/no) The total score varies from 27 to 81
Sense of competence questionnaire
This 35-item questionnaire covers three areas: the impact of caregiving on the caregiver's personal life, satisfaction with one's own performance as a caregiver, and satisfaction with the person with dementia as a recipient of care Each item is scored from 1 ("yes") to 3 ("No") and 2 (Yes/no) The total score varies from 27 to 81
Ressource Utilization in Dementia (RUD)
The questionnaire allows us to estimate the medico-social costs associated with the care of the patient. This estimate is based on the evaluation of the quantity of formal resources (including social services, home care) and informal resources (care and assistance provided by the caregiver) involved in the day-to-day care of the patient; the resources are valued economically using the health insurance rates, where applicable, and the hourly costs of medical and social assistance at home
Ressource Utilization in Dementia (RUD)
The questionnaire allows us to estimate the medico-social costs associated with the care of the patient. This estimate is based on the evaluation of the quantity of formal resources (including social services, home care) and informal resources (care and assistance provided by the caregiver) involved in the day-to-day care of the patient; the resources are valued economically using the health insurance rates, where applicable, and the hourly costs of medical and social assistance at home
Ressource Utilization in Dementia (RUD)
The questionnaire allows us to estimate the medico-social costs associated with the care of the patient. This estimate is based on the evaluation of the quantity of formal resources (including social services, home care) and informal resources (care and assistance provided by the caregiver) involved in the day-to-day care of the patient; the resources are valued economically using the health insurance rates, where applicable, and the hourly costs of medical and social assistance at home
Full Information
NCT ID
NCT05433441
First Posted
June 21, 2022
Last Updated
December 7, 2022
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT05433441
Brief Title
Evaluation of the Effectiveness of the Parkinson Specialized Teams Intervention
Acronym
ES-Park
Official Title
Evaluation of the Effectiveness of the Parkinson's Specialized Teams Intervention on the Quality of Life of Parkinson's Patients in the Territory of the Nouvelle-Aquitaine: ES-Park Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2022 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A pilot experiment interventional study is proposed in order to set up multidisciplinary team for Parkinson's patients at home. The aim of this study is to evaluate the effectiveness of this specialized Parkinson's team (ESPark) intervention a on the quality of life of patients with moderate to severe Parkinson's disease
Detailed Description
Parkinson's disease (PD) and related disorders are the second most common cause of motor disability in the elderly after stroke. Progressively, the disability impacts the activities of daily living and social life of Parkinson's patients with a major impact on their quality of life. The diversity and complexity of the needs of parkinsonian patients and their caregivers justify a specific multidisciplinary approach. Several studies have evaluated the effectiveness of the intervention of such teams on the maintenance of activities of daily living and quality of life of Parkinson's patients with contradictory results. In France, the experience of specialized Alzheimer teams (ESA) based on the same concept seems to have brought positive results on autonomy and resocialization. Based on the positive experience of ESA intervention in Alzheimer's disease and in view of the data in the literature on Parkinson's disease, we would like to develop the same type of care with teams adapted to the problems of Parkinson's disease patients, which we could call ESParks, and to evaluate the effectiveness of such teams in the context of support for Parkinson's patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson, Quality of life, Complementary non drug intervention, Multidisciplinary approach
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard care
Arm Type
No Intervention
Arm Title
ESPark Intervention
Arm Type
Experimental
Arm Description
Under medical prescription and in addition to medical and physiotherapy care, the ESPark will intervene in an ecological way with Parkinson's patients in order to rehabilitate them, maintain their autonomy in their daily life and their social life with the aim of improving the quality of life of the patient and his main caregiver. Beyond a rehabilitative intervention in the home, the ESPark's mission would also be to optimize the patient's living environment and possibly help with the implementation of the necessary aids in the continuity of medical care.
Intervention Type
Procedure
Intervention Name(s)
ESPark Intervention
Intervention Description
The treatment will include 15 sessions (1 session per week). An initial assessment will be carried out during the first session in order to determine the objectives and the personalized follow-up.
Primary Outcome Measure Information:
Title
Score of quality of life scale (PDQ 39)
Description
Self-questionnaire in 39 items evaluating the quality of life of Parkinson's patients from a motor and psychological point of view. Each question is rated from 0 (no disturbance) to 4 (maximum disturbance). The items are divided into 8 dimensions (activity of daily living, emotional well-being, psychological discomfort, social support, cognitive impairment, communication, physical discomfort, mobility) It consists of 39 items with a total score that varies from 0 to 154
Time Frame
Initial Visit - Day 0
Title
Score of quality of life scale (PDQ 39)
Description
Self-questionnaire in 39 items evaluating the quality of life of Parkinson's patients from a motor and psychological point of view. Each question is rated from 0 (no disturbance) to 4 (maximum disturbance). The items are divided into 8 dimensions (activity of daily living, emotional well-being, psychological discomfort, social support, cognitive impairment, communication, physical discomfort, mobility) It consists of 39 items with a total score that varies from 0 to 154
Time Frame
6 months
Secondary Outcome Measure Information:
Title
IADL assessment
Description
Assessment of the level of dependence in instrumental activities of daily living It consists of 9 items with a total score that varies from 0 to 36 Each item is scored from 0 (autonom) to 4 (no autonom) or NA
Time Frame
Initial Visit - Day 0
Title
IADL assessment
Description
Assessment of the level of dependence in instrumental activities of daily living
Time Frame
6 months
Title
IADL assessment
Description
Assessment of the level of dependence in instrumental activities of daily living
Time Frame
12 months
Title
Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Rate
Description
Used to evaluate the various motor and non-motor symptoms. In this protocol, only motor examination will be carried out. This part includes the following items: speech, facial expression, rigidity, finger tapping, hand movements, hand pronation supination movements, toe tapping, leg agility, getting up from the examination chair, walking, postural stability, posture, overall spontaneity of movement, postural hand tremor, hand action tremor, amplitude of resting tremor, constancy of resting tremor. The items of the Parkinsonian triad are evaluated on the different parts of the body (extremities of the limbs, lip and jaw for resting tremor and neck for rigidity). The presence of dyskinesias is mentioned at the end of the evaluation and if they interfered with the motor examination, as well as the global scale of Hoehn and Yahr. All items are rated from 0 to 4 and are clearly defined : 0: normal, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe
Time Frame
Initial Visit - Day 0
Title
Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Rate
Description
Used to evaluate the various motor and non-motor symptoms. In this protocol, only motor examination will be carried out. This part includes the following items: speech, facial expression, rigidity, finger tapping, hand movements, hand pronation supination movements, toe tapping, leg agility, getting up from the examination chair, walking, postural stability, posture, overall spontaneity of movement, postural hand tremor, hand action tremor, amplitude of resting tremor, constancy of resting tremor. The items of the Parkinsonian triad are evaluated on the different parts of the body (extremities of the limbs, lip and jaw for resting tremor and neck for rigidity). The presence of dyskinesias is mentioned at the end of the evaluation and if they interfered with the motor examination, as well as the global scale of Hoehn and Yahr. All items are rated from 0 to 4 and are clearly defined : 0: normal, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe
Time Frame
6 months
Title
Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Rate
Description
Used to evaluate the various motor and non-motor symptoms. In this protocol, only motor examination will be carried out. This part includes the following items: speech, facial expression, rigidity, finger tapping, hand movements, hand pronation supination movements, toe tapping, leg agility, getting up from the examination chair, walking, postural stability, posture, overall spontaneity of movement, postural hand tremor, hand action tremor, amplitude of resting tremor, constancy of resting tremor. The items of the Parkinsonian triad are evaluated on the different parts of the body (extremities of the limbs, lip and jaw for resting tremor and neck for rigidity). The presence of dyskinesias is mentioned at the end of the evaluation and if they interfered with the motor examination, as well as the global scale of Hoehn and Yahr. All items are rated from 0 to 4 and are clearly defined : 0: normal, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe
Time Frame
12 months
Title
Non-motor symptoms Scale for Parkinson's Disease (NMSS)
Description
30-item scale that assesses a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The NMSS measures the severity and frequency of non-motor symptoms across nine dimensions. The scale can be used for patients in all stages of PD.
Time Frame
Initial Visit - Day 0
Title
Non-motor symptoms Scale for Parkinson's Disease (NMSS)
Description
30-item scale that assesses a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The NMSS measures the severity and frequency of non-motor symptoms across nine dimensions. The scale can be used for patients in all stages of PD.
Time Frame
6 months
Title
Non-motor symptoms Scale for Parkinson's Disease (NMSS) score
Description
30-item scale that assesses a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The NMSS measures the severity and frequency of non-motor symptoms across nine dimensions. The scale can be used for patients in all stages of PD.
Time Frame
12 months
Title
Montreal Cognitive Assessment (MOCA) score
Description
The MoCA assesses mild cognitive dysfunction. It assesses the following functions: short-term memory, visual-spatial skills, executive functions, attention, concentration, working memory, language, abstraction, calculation and orientation in time and space. Cognitive impairment is assessed using a 30-point score (27-30: no cognitive impairment; 18-26: mild; 10-17: moderate; < 10: severe).
Time Frame
Initial Visit - Day 0
Title
Montreal Cognitive Assessment (MOCA) score
Description
The MoCA assesses mild cognitive dysfunction. It assesses the following functions: short-term memory, visual-spatial skills, executive functions, attention, concentration, working memory, language, abstraction, calculation and orientation in time and space. Cognitive impairment is assessed using a 30-point score (27-30: no cognitive impairment; 18-26: mild; 10-17: moderate; < 10: severe).
Time Frame
6 months
Title
Montreal Cognitive Assessment (MOCA) score
Description
The MoCA assesses mild cognitive dysfunction. It assesses the following functions: short-term memory, visual-spatial skills, executive functions, attention, concentration, working memory, language, abstraction, calculation and orientation in time and space. Cognitive impairment is assessed using a 30-point score (27-30: no cognitive impairment; 18-26: mild; 10-17: moderate; < 10: severe).
Time Frame
12 months
Title
Beck Depression Inventory (BDI-II) score
Description
Self-questionnaire comprising a list of 21 items measuring the somatic, affective and cognitive severity of depressive symptoms. Each item is rated for symptom severity and/or frequency, over the past 7 days, on a 4-point scale ranging from 0 to 3. Higher scores indicate severe symptomatology.
Time Frame
Initial Visit - Day 0
Title
Beck Depression Inventory (BDI-II) score
Description
Self-questionnaire comprising a list of 21 items measuring the somatic, affective and cognitive severity of depressive symptoms. Each item is rated for symptom severity and/or frequency, over the past 7 days, on a 4-point scale ranging from 0 to 3. Higher scores indicate severe symptomatology.
Time Frame
6 months
Title
Beck Depression Inventory (BDI-II) score
Description
Self-questionnaire comprising a list of 21 items measuring the somatic, affective and cognitive severity of depressive symptoms. Each item is rated for symptom severity and/or frequency, over the past 7 days, on a 4-point scale ranging from 0 to 3. Higher scores indicate severe symptomatology.
Time Frame
12 months
Title
Parkinson Anxiety Scale (PAS) Score
Description
Self-questionnaire assessing anxiety in Parkinson's disease dealing with several dimensions of anxiety: Persistent anxiety (5 items), Episodic anxiety (4 items), Avoidance behavior (3 items). Each item is scored from 0 (not at all) to 4 (strongly or almost always).
Time Frame
Initial Visit - Day 0
Title
Parkinson Anxiety Scale (PAS) Score
Description
Self-questionnaire assessing anxiety in Parkinson's disease dealing with several dimensions of anxiety: Persistent anxiety (5 items), Episodic anxiety (4 items), Avoidance behavior (3 items). Each item is scored from 0 (not at all) to 4 (strongly or almost always).
Time Frame
6 months
Title
Parkinson Anxiety Scale (PAS) Score
Description
Self-questionnaire assessing anxiety in Parkinson's disease dealing with several dimensions of anxiety: Persistent anxiety (5 items), Episodic anxiety (4 items), Avoidance behavior (3 items). Each item is scored from 0 (not at all) to 4 (strongly or almost always).
Time Frame
12 months
Title
Reduced Neuropsychiatric Inventory (NPI-R) score
Description
Used to assesses 12 domains of psychobehavioral disorders (21). It is a questionnaire consisting of a screening question and seven to nine items for each of the 12 domains: delusions, hallucinations, agitation/aggressiveness, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor aberration, behavioural disorders, sleep, appetite and eating. The score ranges from 0 to 144 .
Time Frame
Initial Visit - Day 0
Title
Reduced Neuropsychiatric Inventory (NPI-R) score
Description
Used to assesses 12 domains of psychobehavioral disorders (21). It is a questionnaire consisting of a screening question and seven to nine items for each of the 12 domains: delusions, hallucinations, agitation/aggressiveness, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor aberration, behavioural disorders, sleep, appetite and eating. The score ranges from 0 to 144 .
Time Frame
6 months
Title
Reduced Neuropsychiatric Inventory (NPI-R) score
Description
Used to assesses 12 domains of psychobehavioral disorders. It is a questionnaire consisting of a screening question and seven to nine items for each of the 12 domains: delusions, hallucinations, agitation/aggressiveness, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor aberration, behavioural disorders, sleep, appetite and eating. The score ranges from 0 to 144 .
Time Frame
12 months
Title
Zarit scale score
Description
This scale assesses caregiver burden ; it consists of 22 items with a total score that varies from 0 to 88. (score ≤20, no burden - score> 60, severe burden).
Time Frame
Initial Visit - Day 0
Title
Zarit scale score
Description
This scale assesses caregiver burden ; it consists of 22 items with a total score that varies from 0 to 88. (score ≤20, no burden - score> 60, severe burden).
Time Frame
6 Months
Title
Zarit scale score
Description
This scale assesses caregiver burden ; it consists of 22 items with a total score that varies from 0 to 88. (score ≤20, no burden - score> 60, severe burden).
Time Frame
12 Months
Title
State Trait Anxiety Inventory short scale (STAI-E and STAI-T) score
Description
This anxiety scale consists of 2 scales of 20 questions that assess how subjects feel at the time and generally.
Time Frame
Initial Visit - Day 0
Title
State Trait Anxiety Inventory short scale (STAI-E and STAI-T) score
Description
This anxiety scale consists of 2 scales of 20 questions that assess how subjects feel at the time and generally.
Time Frame
6 months
Title
State Trait Anxiety Inventory short scale (STAI-E and STAI-T) score
Description
This anxiety scale consists of 2 scales of 20 questions that assess how subjects feel at the time and generally.
Time Frame
12 months
Title
Quality of life as measured by the PQoL Carers.
Description
Quality of life questionnaire for caregivers Self-questionnaire comprising a list of 26 items with a total score that varies from 0 to 104
Time Frame
Initial Visit - Day 0
Title
Quality of life as measured by the PQoL Carers.
Description
Quality of life questionnaire for caregivers Self-questionnaire comprising a list of 26 items with a total score that varies from 0 to 104
Time Frame
6 months
Title
Quality of life as measured by the PQoL Carers.
Description
Quality of life questionnaire for caregivers Self-questionnaire comprising a list of 26 items with a total score that varies from 0 to 104
Time Frame
12 months
Title
Sense of competence questionnaire
Description
This 35-item questionnaire covers three areas: the impact of caregiving on the caregiver's personal life, satisfaction with one's own performance as a caregiver, and satisfaction with the person with dementia as a recipient of care Each item is scored from 1 ("yes") to 3 ("No") and 2 (Yes/no) The total score varies from 27 to 81
Time Frame
Initial Visit - Day 0
Title
Sense of competence questionnaire
Description
This 35-item questionnaire covers three areas: the impact of caregiving on the caregiver's personal life, satisfaction with one's own performance as a caregiver, and satisfaction with the person with dementia as a recipient of care Each item is scored from 1 ("yes") to 3 ("No") and 2 (Yes/no) The total score varies from 27 to 81
Time Frame
6 months
Title
Sense of competence questionnaire
Description
This 35-item questionnaire covers three areas: the impact of caregiving on the caregiver's personal life, satisfaction with one's own performance as a caregiver, and satisfaction with the person with dementia as a recipient of care Each item is scored from 1 ("yes") to 3 ("No") and 2 (Yes/no) The total score varies from 27 to 81
Time Frame
12 months
Title
Ressource Utilization in Dementia (RUD)
Description
The questionnaire allows us to estimate the medico-social costs associated with the care of the patient. This estimate is based on the evaluation of the quantity of formal resources (including social services, home care) and informal resources (care and assistance provided by the caregiver) involved in the day-to-day care of the patient; the resources are valued economically using the health insurance rates, where applicable, and the hourly costs of medical and social assistance at home
Time Frame
Initial Visit - Day 0
Title
Ressource Utilization in Dementia (RUD)
Description
The questionnaire allows us to estimate the medico-social costs associated with the care of the patient. This estimate is based on the evaluation of the quantity of formal resources (including social services, home care) and informal resources (care and assistance provided by the caregiver) involved in the day-to-day care of the patient; the resources are valued economically using the health insurance rates, where applicable, and the hourly costs of medical and social assistance at home
Time Frame
6 Months
Title
Ressource Utilization in Dementia (RUD)
Description
The questionnaire allows us to estimate the medico-social costs associated with the care of the patient. This estimate is based on the evaluation of the quantity of formal resources (including social services, home care) and informal resources (care and assistance provided by the caregiver) involved in the day-to-day care of the patient; the resources are valued economically using the health insurance rates, where applicable, and the hourly costs of medical and social assistance at home
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
For the patient:
Patient with a diagnosis of idiopathic Parkinson's disease
Patient over 18 years ;
Patient with a Hoehn and Yahr Stage greater than or equal to 3;
Patient without major cognitive impairment defined by a MOCA score ≥21
Patient living at home ;
Patient with an identified non-professional primary caregiver;
Person affiliated with or benefiting from a social security plan;
Free, informed and and express consent (confirmed in writing) (no later than the day of inclusion and before any examination required by the research).
For the caregiver:
Male or female over 18 years
Able to respond to research interviews/questionnaires
Free, informed and express consent (confirmed in writing) (no later than the day of inclusion and before any examination required by the research).
Exclusion Criteria:
For the patient:
Patient with medically indicated dementia impairing comprehension and adherence, and/or with severe confusion or psycho-hallucinatory state;
Institutionalized or foster care patients;
Patients with a known severe and unstable general pathology that does not allow for patient follow-up;
Patients already included in another non-drug management trial;
Patients whose institutionalization is envisaged in the short term (within 6 months) or for whom a change of residence is envisaged in the short term and would not allow for follow-up assessments;
Patients under guardianship or unable to express consent
Primary caregiver not wishing to participate in the study or unable to be available for the planned study follow-up;
Presence of a primary caregiver with a known severe and unstable disease that does not allow for the conduct of the study;
Presence of a primary caregiver with a known cognitive or psychiatric disorder (chronic progressive psychosis) that does not allow for the proper conduct of the study.
Pregnant or breastfeeding woman.
For the caregiver:
Unable to follow the research interviews or questionnaires.
Primary caregiver not wishing to participate in the study or unable to be available for the planned study follow-up;
Primary caregiver with a known severe and unstable illness that does not allow for the proper conduct of the study;
Primary caregiver with known cognitive or psychiatric disorders (chronic progressive psychosis) that do not allow the study to be conducted properly.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra FOUBERT-SAMIER, Dr
Phone
05 57 82 12 53
Email
alexandra.samier-foubert@u-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sandrine DUPOUY
Phone
05 57 82 14 62
Email
sandrine.dupouy@chu-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra FOUBERT-SAMIER
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Pellegrin
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra FOUBERT-SAMIER, Dr
Email
alexandra.samier-foubert@u-bordeaux.fr
Facility Name
CHU de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Luc HOUETO, Pr
Email
jean-luc.houeto@chu-limoges.fr
Facility Name
CHU Poitiers
City
Poitiers
ZIP/Postal Code
90577
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle BENATRU, Dr
Email
isabelle.benatru@chu-poitiers.fr
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Effectiveness of the Parkinson Specialized Teams Intervention
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