Quality of Life of the Patient and the Burden of the Caregiver in Progressive Supranuclear Palsy

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Brief Title

Quality of Life of the Patient and the Burden of the Caregiver in Progressive Supranuclear Palsy

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

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 (Student's 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 (Student's 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 Type

Observational [Patient Registry]


Primary Outcome

score of PSP-QoL questionnaire


Condition

Progressive Supranuclear Palsy

Intervention

PSP-QoL

Study Arms / Comparison Groups

 patients
Description:  patients with Progressive supranuclear palsy. PSP-QoL will be performed in this group

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

160

Start Date

December 2018

Completion Date

June 2021

Primary Completion Date

December 2020

Eligibility Criteria

        Inclusion Criteria (patients)

        Female or male, age ≥ 40 years at the time of onset of symptoms

          -  diagnosis of possible or probable PSP according to the criteria of Litvan (1996b)

          -  agreeing to participate in the study

          -  subject with no severe cognitive impairment (MMS> 20/30)

          -  subject who does not have psycho-behavioral comorbidity deemed to be severe enough to
             make his assessment impossible

          -  subject not presenting a measure of legal protection

        Exclusion Criteria (patients)

          -  Age <40 years at the onset of symptoms

          -  Diagnosis other than PSP (including other Parkinsonian syndromes)

          -  Presence of another concomitant neurological disease

          -  subject with severe cognitive impairment (MMS≤20 / 30)

          -  subject presenting psycho-behavioral comorbidities considered sufficiently severe to
             make it impossible to evaluate

          -  subject under legal protection

          -  subject not affiliated to a social security scheme

        Inclusion Criteria (caregivers)

          -  Female or male, age ≥ 18 years

          -  designated by the patient as the person closest to him / her

          -  agreeing to participate in the study

          -  subject affiliated to a social security scheme

        Exclusion Criteria (caregivers)

          -  Age <18 years

          -  Not designated by the patient as the person closest to him / her

          -  Not agreeing to participate in the study

          -  subject not affiliated to a social security scheme
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

EMILIE GARRIDO PRADALIE, +33 491384360, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT03638505

Organization ID

2017-62


Responsible Party

Sponsor

Study Sponsor

Assistance Publique Hopitaux De Marseille


Study Sponsor

EMILIE GARRIDO PRADALIE, Study Director, APHM


Verification Date

August 2018