Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04837352
Status:
RECRUITING
Last Update Posted:
2024-03-26
First Post:
2021-02-02
Brief Title:
Therapeutic Adherence of Multiple Sclerosis Patients
Sponsor:
Lille Catholic University
Organization:
Lille Catholic University
Study Overview
Official Title:
Obstacles and Levers of the Therapeutic Adherence of Multiple Sclerosis Patients
Status:
RECRUITING
Status Verified Date:
2024-03
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:
FELSA-SEP
Brief Summary:
The goal of this study is to assess the role of sociocognitive and interpersonal factors in the therapeutic adherence of multiple sclerosis patients This study will provide a better understanding of the socio-psychological issues associated with different types of non-adherence to treatment and identify the risk factors and vulnerability of each patient
Detailed Description:
Multiple sclerosis is a chronic and progressive disease that affects young adults between 20 and 40 years old impacting significantly the patients quality of life
The adherence to therapy affects the long-term functional clinical course lower risk of relapses reduction in disability progression and quality of life The non-adherence rate to therapy in multiple sclerosis is estimated at 40 The main identified causes of non-adherence are forgetting to take treatment and adverse effects of drugs
Sociocognitive models as the Theory of Planned Behaviour TPB have been developed to help to understand and predict health-related behaviours This model postulates that the intention to adopt a behaviour is one of the major determinants in the context of health This intention comes from three independent elements
Personal positive or negative attitudes towards the behaviour
Social expectations or entourage perception subjective norms
Difficulty in accomplishing this behaviour perceived control
Multiple sclerosis adherence to therapy studies have mainly focused on somatic variables physical disability illness duration type of treatment and some clinical variables cognitive impairment fatigue depression The few studies that have examined the multiple sclerosis therapeutic adherence determinants have mainly taken a one-dimensional perspective such as perceived control
In the FELSA-SEP study the role of sociocognitive factors norms and beliefs perceived threat to disease and health behaviours and interpersonal factors social support patient-doctor relationship will be explored
The adherence to therapy affects the long-term functional clinical course lower risk of relapses reduction in disability progression and quality of life The non-adherence rate to therapy in multiple sclerosis is estimated at 40 The main identified causes of non-adherence are forgetting to take treatment and adverse effects of drugs
Sociocognitive models as the Theory of Planned Behaviour TPB have been developed to help to understand and predict health-related behaviours This model postulates that the intention to adopt a behaviour is one of the major determinants in the context of health This intention comes from three independent elements
Personal positive or negative attitudes towards the behaviour
Social expectations or entourage perception subjective norms
Difficulty in accomplishing this behaviour perceived control
Multiple sclerosis adherence to therapy studies have mainly focused on somatic variables physical disability illness duration type of treatment and some clinical variables cognitive impairment fatigue depression The few studies that have examined the multiple sclerosis therapeutic adherence determinants have mainly taken a one-dimensional perspective such as perceived control
In the FELSA-SEP study the role of sociocognitive factors norms and beliefs perceived threat to disease and health behaviours and interpersonal factors social support patient-doctor relationship will be explored
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