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

NCT03638505 | Recruiting

• 1 other identifier: 2017-62
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Progressive Supranuclear Palsy

Outcome Measures

Primary Outcomes (1)

• score of PSP-QoL questionnaire

  the score obtained by group will be compare Progressive Supranuclear Palsy (PSP) Quality of Life questionnaire by Schrag and collaborators in 2006. 14 items, 5 degree from no problem, slight problem, moderate problem, marked problem to extreme problem (1 to 5 points) minimum score:14 maximum score : 70

  1 hour

Study Arms (2)

patients

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

Other: PSP-QoL

caregiver

the caregiver of the patient with Progressive supranuclear palsy PSP-QoL will be performed in this group

Other: PSP-QoL

Interventions

PSP-QoL OTHER

PSP-QoL is a patient-reported outcome measure for progressive supranuclear palsy (PSP). The Supranuclear Palsy Quality of Life scale (PSP-QoL) may be a helpful patient-reported scale for clinical trials and studies in PSP. PSP-QoL consists of 28 items scored on a 3- or 5-point Likert scale, with the total score ranging from 0 to 100. Each item is scored from either 0 to 4, with the exception of four items, which are scored from 0 to 2, with higher scores indicating more-severe disability or movement abnormality. Items are in six categories: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. The scale includes comments and/or instructions for each item and word anchors to explain the ratings.

caregiver; patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PSP patients with their caregivers

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Des Hopitaux de Marseille

Marseille, PACA, 13354, France

RECRUITING

MeSH Terms

Conditions

Supranuclear Palsy, Progressive

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Neurodegenerative Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• EMILIE GARRIDO PRADALIE

  APHM

  STUDY DIRECTOR

Central Study Contacts

ALEXANDRE EUSEBIO, MD

CONTACT

+33 491384360; Alexandre.EUSEBIO@ap-hm.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2018
• First Posted: August 20, 2018
• Study Start: July 4, 2019
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 8, 2024

Record last verified: 2024-01

Locations

FR (1)