Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06645626
Status:
RECRUITING
Last Update Posted:
None
First Post:
2022-09-30
Brief Title:
Utilisation of Health Services and Quality of Life in Patients With Atypical Parkinsonian Syndromes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Utilisation of Health Services and Quality of Life in Patients With Atypical Parkinsonian Syndromes
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
UHSQOLAPS
Brief Summary:
The study will compare health care utilisation and quality of life for patients with progressive supranuclear palsy corticobasal syndrome and multiple system atrophy in different parts of the region that our specialist clinic operates in with different services as well as in other regions with no specialist clinics This study aims to investigate which aspects of the service are most beneficial for the patients and to determine the influence of support services and specialty clinics on patients and their carers
Detailed Description:
Progressive supranuclear palsy PSP Multiple system atrophy MSA and corticobasal syndrome CBS are rare neurological diseases which rapidly get worse They cause problems with movement vision thinking swallowing and speech and currently have no treatment to cure the disease or to treat many of the symptoms They look superficially like Parkinsons disease and so are called collectively atypical Parkinsonian syndromes APS Quality of life for patients and their family is very poor worse than motor neuron disease for example Due to all the problems related to their illness patients often have to be admitted as an emergency and need a lot of care Currently there is little research on how patients should be cared for by the NHS While there are many variations in types of clinics two different models for NHS clinics are 1 a Neurology Consultant seeing them in clinic alone or 2 a Neurologist seeing them in a specialist multidisciplinary MDT clinic with a clinic coordinator in close cooperation with community teams consisting of speech and language therapists physiotherapists occupational therapists palliative care and a Neurology nurse The second type of clinic would be more expensive but may provide the patient and their family with more information about the disease and support This could improve the patient and careramp39s ability to manage the disease the patient and careramp39s quality of life and experience of care and may reduce emergency admissions to hospital The clinic the investigators run in Wessex covers three counties with a wide variation in services on offer In some of the patch community services are scarce and patients find it very difficult to come into the central clinic where the coordinator is based In other parts there is a very comprehensive service with coordinators and multiple health professionals organised into a responsive and dedicated community MDT The variation of MDT involvement in our clinicamp39s catchment area enables us to study the influence of different levels of support on our patients
Our study includes two stages In the first stage we will investigate the impact of different availability of services within our specialist clinic catchment area to determine the relative impact of support services on patients and their carers The second stage will compare patients from our specialist clinic to patients seen elsewhere in the country in a non specialist setting This will provide a much starker contrast of differences in care and outcomes
Patient recruitment would be from our clinic list however for patients who do not attend a specialist centre from different regions of the country we will be collaborating with the PSP Association PSPA to help us identify interested patients
Informed consent is an absolute pre-requisite for participation in this study Explicit consent will be obtained at the start of the study with regards ongoing involvement in the study in the event of loss of capacity This research will assess patients using quantitative methods Using questionnaires patients and their carers ie family members or friends who provide unpaid support will be asked about their quality of life and how much the patients use health services at the beginning of the research and every 6 months to see if there is a difference between the types of care
Quality of life data will be collected using a commonly used EQ-5D-5L or disease specific PQOL PSPQOL MSAQOL QOL measures Additional information will be collected from patients including age disease duration medication impulsivity ampamp apathy collected using the Cambridge Behavioural inventory revised CBI-r and the Cambridge Questionnaire for Apathy and Impulsivity Traits CAMQUAIT - A Cambridge questionnaire
Disease severity and cognition will be assessed using Montreal Cognitive Assessment MOCA for cognition and PSP rating scale PSPRS PSP Clinical Deficits scalePSPCDS or unified MSA rating scale UMSARS for disease severity to ensure that recruited patients are as similar as possible with regard to disease type stage and disability The researcher will also access clinical data to provide contextual information regarding the patient and their disease as outlined above This will predominantly be at UHS for QOLAPS1 patients but may also be requested from other hospitals in the region and the GP For QOLAPS2 patients we will request information from any NHS hospital in the region and their GP We will also request data from NHS digital and other UK NHS databases - in particular the Office of National Statistics ONS This will predominantly be for mortality data which will enable us to look at outcomes including duration of disease cause and place of death and we will look to relate that to the clinical care patients received
A few of the assessments require an in-person assessment such as the MOCA and the PSPRS PSPCDS or UMSARS These measures are often a normal part of our clinical care and will be done at the patients clinic visit For the group of patients who are not attending our clinics we would arrange a home visit and carry out the assessments at the patients home
Our study includes two stages In the first stage we will investigate the impact of different availability of services within our specialist clinic catchment area to determine the relative impact of support services on patients and their carers The second stage will compare patients from our specialist clinic to patients seen elsewhere in the country in a non specialist setting This will provide a much starker contrast of differences in care and outcomes
Patient recruitment would be from our clinic list however for patients who do not attend a specialist centre from different regions of the country we will be collaborating with the PSP Association PSPA to help us identify interested patients
Informed consent is an absolute pre-requisite for participation in this study Explicit consent will be obtained at the start of the study with regards ongoing involvement in the study in the event of loss of capacity This research will assess patients using quantitative methods Using questionnaires patients and their carers ie family members or friends who provide unpaid support will be asked about their quality of life and how much the patients use health services at the beginning of the research and every 6 months to see if there is a difference between the types of care
Quality of life data will be collected using a commonly used EQ-5D-5L or disease specific PQOL PSPQOL MSAQOL QOL measures Additional information will be collected from patients including age disease duration medication impulsivity ampamp apathy collected using the Cambridge Behavioural inventory revised CBI-r and the Cambridge Questionnaire for Apathy and Impulsivity Traits CAMQUAIT - A Cambridge questionnaire
Disease severity and cognition will be assessed using Montreal Cognitive Assessment MOCA for cognition and PSP rating scale PSPRS PSP Clinical Deficits scalePSPCDS or unified MSA rating scale UMSARS for disease severity to ensure that recruited patients are as similar as possible with regard to disease type stage and disability The researcher will also access clinical data to provide contextual information regarding the patient and their disease as outlined above This will predominantly be at UHS for QOLAPS1 patients but may also be requested from other hospitals in the region and the GP For QOLAPS2 patients we will request information from any NHS hospital in the region and their GP We will also request data from NHS digital and other UK NHS databases - in particular the Office of National Statistics ONS This will predominantly be for mortality data which will enable us to look at outcomes including duration of disease cause and place of death and we will look to relate that to the clinical care patients received
A few of the assessments require an in-person assessment such as the MOCA and the PSPRS PSPCDS or UMSARS These measures are often a normal part of our clinical care and will be done at the patients clinic visit For the group of patients who are not attending our clinics we would arrange a home visit and carry out the assessments at the patients home
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None