Ignite Creation Date:
2024-05-06 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 12:44 PM
Study NCT ID:
NCT03509064
Status:
RECRUITING
Last Update Posted:
2021-08-30
First Post:
2018-02-26
Brief Title:
Medico-economic and Quality of Life Impact of Sjogren-associated Small Fiber Neuropathy
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
The Medico-economic Impact and Quality of Life of the Small-fiber Neuropathy Associated by Using Validated Scales SF36 DN4 PROFAD SSI ESPRI
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
RECRUITING
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:
SFINESS-QoLEco
Brief Summary:
BACKGROUND Sjögrens syndrome is an autoimmune disease whose prevalence is estimated between 200 and 500 patients per 100000 persons in France 120 to 500000 patients It affects women 90 between 40 and 60 years of age and main manifestations are generalized sicca syndrome ocular oral cutaneous and arthralgia In 20 of cases Sjögrens syndrome is associated with peripheral neuropathies and the most common form is painful small fiber neuropathy SFN SFNs are mainly featured by neuropathic pain including burns 90 numbness 875 tingling 725 electric shocks 70 and tingling 825 and also autonomic disorders 50 to 70
However there are still important issues that deserve to be investigated by clinical and basic research Among these issues this study will focus on
The impact of SFN on the quality of life of patients with Sjögrens syndrome
The medico-economic impact of the SFN taking into account the repercussions on the quality of life including professional life usual care cost analgesics medical and paramedical consultations hospitalizations or emergency
EXPECTED RESULTS
Confirmation of the major impairment in the quality of life of patients with Sjogren-associated SFN
Analysis of correlations to highlight or not clinical or biological factors associated with quality of life impairment
Evaluation of the cost attributed to the presence of an SFN in patients with Sjögrens syndrome and the pharmaco-economic interest of conventional therapeutic management analgesic treatment consultation pain compared to the cost of more aggressive immunomodulatory treatments
However there are still important issues that deserve to be investigated by clinical and basic research Among these issues this study will focus on
The impact of SFN on the quality of life of patients with Sjögrens syndrome
The medico-economic impact of the SFN taking into account the repercussions on the quality of life including professional life usual care cost analgesics medical and paramedical consultations hospitalizations or emergency
EXPECTED RESULTS
Confirmation of the major impairment in the quality of life of patients with Sjogren-associated SFN
Analysis of correlations to highlight or not clinical or biological factors associated with quality of life impairment
Evaluation of the cost attributed to the presence of an SFN in patients with Sjögrens syndrome and the pharmaco-economic interest of conventional therapeutic management analgesic treatment consultation pain compared to the cost of more aggressive immunomodulatory treatments
Detailed Description:
Primary objective Identify the predictors of quality of life impairment and costs of management of patients with Sjögrens syndrome and small fiber neuropathy SFN
Secondary objectives
1 Hospital drug and city-care costs
2 Distribution of cost items
3 Part of costs attributable to pSS-associated SFN
4 Loss of quality of life attributable to pSS-associated SFN
5 Relationship between the domains of the EQ 5D questionnaire and the other specific quality of life questionnaires
6 Association of the EQ 5D and other questionnaires with the costs part of the costs variance that might be explained by the quality of life
PATIENTS AND METHODS Study population
Monocentric study in the Department of Internal Medicine of Lariboisière Fernand Widal Hospital
All included patients fulfilled 2002-criteria of primary Sjogren syndrome
Patients are classified into 2 arms
Arm1 patients with Sjögrens syndrome and definite SFN
Arm2 Control Group patients with Sjögrens syndrome and WITHOUT clinical and paraclinical arguments for peripheral neuropathy
RESARCH PROCESS
This study will be based on the delivery and analysis of validated questionnaires collection sheet in chronic diseases pains or Sjögrens syndrome
SF-36 for quality of life
DN4 questionnaire to estimate the probability of neuropathic pain
EQ5D Health questionnaire
ESSPRI 4 questions Sjogren-patient questionnaire
PROFAD-SSI 19 questions to assess tiredness discomfort pain and dryness symptoms associated with Sjögrens syndrome
The economic evaluation will be done after the inclusion visit and will be based on the collection of care resources consumed by the patients during a period of 6 months
Secondary objectives
1 Hospital drug and city-care costs
2 Distribution of cost items
3 Part of costs attributable to pSS-associated SFN
4 Loss of quality of life attributable to pSS-associated SFN
5 Relationship between the domains of the EQ 5D questionnaire and the other specific quality of life questionnaires
6 Association of the EQ 5D and other questionnaires with the costs part of the costs variance that might be explained by the quality of life
PATIENTS AND METHODS Study population
Monocentric study in the Department of Internal Medicine of Lariboisière Fernand Widal Hospital
All included patients fulfilled 2002-criteria of primary Sjogren syndrome
Patients are classified into 2 arms
Arm1 patients with Sjögrens syndrome and definite SFN
Arm2 Control Group patients with Sjögrens syndrome and WITHOUT clinical and paraclinical arguments for peripheral neuropathy
RESARCH PROCESS
This study will be based on the delivery and analysis of validated questionnaires collection sheet in chronic diseases pains or Sjögrens syndrome
SF-36 for quality of life
DN4 questionnaire to estimate the probability of neuropathic pain
EQ5D Health questionnaire
ESSPRI 4 questions Sjogren-patient questionnaire
PROFAD-SSI 19 questions to assess tiredness discomfort pain and dryness symptoms associated with Sjögrens syndrome
The economic evaluation will be done after the inclusion visit and will be based on the collection of care resources consumed by the patients during a period of 6 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-A02858-45 | OTHER | IDRCB | None |