Ignite Creation Date:
2024-05-06 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03638505
Status:
RECRUITING
Last Update Posted:
2024-01-08
First Post:
2018-08-16
Brief Title:
Quality of Life of the Patient and the Burden of the Caregiver in Progressive Supranuclear Palsy
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
Cross-sectional Study of the Factors Determining the Quality of Life of the Patient and the Burden of the Caregiver in Progressive Supranuclear Palsy
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Qual-PSP
Brief Summary:
Progressive supranuclear palsy PSP is a rare neurodegenerative disease from the parkinsonian syndrome group
PSP is characterised by the association of a non-doparesponsive parkinsonian syndrome with axial signs The latter predominantly manifest as a psycho-motor slowness an apathy and frontal executive deficits Swallowing impairments may additionally provoke life-threatening situations Today the treatment is mostly symptomatic as no cure is available Given the limited treatment options and its clinical characteristics PSP deeply impact on the patients quality of life QoL as well as on their caregivers Nevertheless a limited number of studies have focused on these aspects A better understaning of the factors determining both patient and cargiver QoL may help optimising their care
the principal objective of this study is to identify the determinants of PSP patients QoL
The secondary objectives are i to identify the determinants medical behavioural socio-economic environmental of PSP patients caregivers QoL and burden ii to validate in French language the QoL scale specific for PSP available in English PSP-QoL
This is a multidisciplinary transversal study 2 subject groups will be included i PSP patients ii caregiver of PSP patients designated by the patient as being the person closest to them Data collected i from the patient socio-demographic social and professionnal environment clinical disease duration and severity neuropsychological evaluation therapeutic mood anxiety coping body image QoL ii from the caregiver socio-demographic social and professionnal environment connection with the patient data relative to their own health mood anxiety coping QoL burden
Progress patient information designation of a caregiver consent collection collection of data Statistical analysis To address the principal objective patient QoL scores will be confronted to the other collected variables Students t-test correlation coefficient The results will be adjusted to the confounding factors using multivariate analyses
PSP is characterised by the association of a non-doparesponsive parkinsonian syndrome with axial signs The latter predominantly manifest as a psycho-motor slowness an apathy and frontal executive deficits Swallowing impairments may additionally provoke life-threatening situations Today the treatment is mostly symptomatic as no cure is available Given the limited treatment options and its clinical characteristics PSP deeply impact on the patients quality of life QoL as well as on their caregivers Nevertheless a limited number of studies have focused on these aspects A better understaning of the factors determining both patient and cargiver QoL may help optimising their care
the principal objective of this study is to identify the determinants of PSP patients QoL
The secondary objectives are i to identify the determinants medical behavioural socio-economic environmental of PSP patients caregivers QoL and burden ii to validate in French language the QoL scale specific for PSP available in English PSP-QoL
This is a multidisciplinary transversal study 2 subject groups will be included i PSP patients ii caregiver of PSP patients designated by the patient as being the person closest to them Data collected i from the patient socio-demographic social and professionnal environment clinical disease duration and severity neuropsychological evaluation therapeutic mood anxiety coping body image QoL ii from the caregiver socio-demographic social and professionnal environment connection with the patient data relative to their own health mood anxiety coping QoL burden
Progress patient information designation of a caregiver consent collection collection of data Statistical analysis To address the principal objective patient QoL scores will be confronted to the other collected variables Students t-test correlation coefficient The results will be adjusted to the confounding factors using multivariate analyses
Detailed Description:
Progressive supranuclear palsy PSP is a rare neurodegenerative disease from the parkinsonian syndrome group It represents 5 to 10 of all parkinsonian syndromes and affects 3000 to 10000 persons in France
PSP is characterised by the association of a non-doparesponsive parkinsonian syndrome with axial signs such as early gait instability and falls oculomotor signs such as a vertical gaze limitation and both cognitive and behavioural disturbances The latter predominantly manifest as a psycho-motor slowness an apathy and frontal executive deficits Swallowing impairments may additionally provoke life-threatening situations Today the treatment is mostly symptomatic as no cure is available Given the limited treatment options and its clinical characteristics PSP deeply impact on the patients quality of life QoL as well as on their caregivers Nevertheless a limited number of studies have focused on these aspects A better understaning of the factors determining both patient and cargiver QoL may help optimising their care
Objectives the principal objective of this study is to identify the determinants motor behavioural socio-economic environemental of PSP patients QoL
The secondary objectives are i to identify the determinants medical behavioural socio-economic environmental of PSP patients caregivers QoL and burden ii to validate in French language the QoL scale specific for PSP available in English PSP-QoL
Methods This is a multidisciplinary transversal study Population 2 subject groups will be included i PSP patients ii caregiver of PSP patients designated by the patient as being the person closest to them Data collected i from the patient socio-demographic social and professionnal environment clinical disease duration and severity neuropsychological evaluation therapeutic mood anxiety coping body image QoL ii from the caregiver socio-demographic social and professionnal environment connection with the patient data relative to their own health mood anxiety coping QoL burden
Progress patient information designation of a caregiver consent collection collection of data Statistical analysis To address the principal objective patient QoL scores will be confronted to the other collected variables Students t-test correlation coefficient The results will be adjusted to the confounding factors using multivariate analyses To address the secondary objective caregiver QoL and burden scores will be confronted to the other collected variables through the same procedure The transcultural validation of the PSP-QoL scale will be obtained using standard methodology forward-backward method acceptability test study of metric properties
Expected results and impact This work will help understanding the social handicap in PSP and may lead to new therapeutic strategies
Relevance of the project No data on PSP-related QoL or caregiver burden are available in France In addition the factors determining these aspects of the disease are poorly understood The motor handicap obviously reduces patients QoL and increases the caregivers burden However the impact of the cognitive and behavioural disturbances and particularly the reduction of social interactions on the QoL of patients and caregiver burden have been less studied
PSP is characterised by the association of a non-doparesponsive parkinsonian syndrome with axial signs such as early gait instability and falls oculomotor signs such as a vertical gaze limitation and both cognitive and behavioural disturbances The latter predominantly manifest as a psycho-motor slowness an apathy and frontal executive deficits Swallowing impairments may additionally provoke life-threatening situations Today the treatment is mostly symptomatic as no cure is available Given the limited treatment options and its clinical characteristics PSP deeply impact on the patients quality of life QoL as well as on their caregivers Nevertheless a limited number of studies have focused on these aspects A better understaning of the factors determining both patient and cargiver QoL may help optimising their care
Objectives the principal objective of this study is to identify the determinants motor behavioural socio-economic environemental of PSP patients QoL
The secondary objectives are i to identify the determinants medical behavioural socio-economic environmental of PSP patients caregivers QoL and burden ii to validate in French language the QoL scale specific for PSP available in English PSP-QoL
Methods This is a multidisciplinary transversal study Population 2 subject groups will be included i PSP patients ii caregiver of PSP patients designated by the patient as being the person closest to them Data collected i from the patient socio-demographic social and professionnal environment clinical disease duration and severity neuropsychological evaluation therapeutic mood anxiety coping body image QoL ii from the caregiver socio-demographic social and professionnal environment connection with the patient data relative to their own health mood anxiety coping QoL burden
Progress patient information designation of a caregiver consent collection collection of data Statistical analysis To address the principal objective patient QoL scores will be confronted to the other collected variables Students t-test correlation coefficient The results will be adjusted to the confounding factors using multivariate analyses To address the secondary objective caregiver QoL and burden scores will be confronted to the other collected variables through the same procedure The transcultural validation of the PSP-QoL scale will be obtained using standard methodology forward-backward method acceptability test study of metric properties
Expected results and impact This work will help understanding the social handicap in PSP and may lead to new therapeutic strategies
Relevance of the project No data on PSP-related QoL or caregiver burden are available in France In addition the factors determining these aspects of the disease are poorly understood The motor handicap obviously reduces patients QoL and increases the caregivers burden However the impact of the cognitive and behavioural disturbances and particularly the reduction of social interactions on the QoL of patients and caregiver burden have been less studied
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None