Clinical Trials Logo

Clinical Trial Summary

The earlier that MS can be diagnosed; the sooner treatment can be initiated with timely reduction of subclinical disease activity and prevention of disability progression. However, significant delays can still occur between noticing the first symptoms and receiving a diagnosis even before a person with symptoms suggestive of MS sees a neurologist. Such delays could be due to heterogeneity of clinical and imaging manifestations, which not only differ between patients, but also vary in individual patients over time. Moreover, lack of awareness of the primary care physicians about MS presentations, the limited accessibility to specialized centers or the non-availability of diagnostic tools such as MRI scanners and lumbar puncture, may further add to this delay and increases the risk of disability. There are also many factors that can contribute to delayed initiation of DMT after diagnosis like inadequate knowledge with DMT, their high coast and limited access to health care insurance services. Like many chronic conditions, non- Adherence to drug therapies is estimated up to 50%, with associated increased morbidity, mortality, and health care costs. To the best of our knowledge, this is the first study in upper Egypt that tries to address these factors. By conducting this study, we aim at identifying factors leading to delayed diagnosis of MS, initiation and adherence to DMT in order to translate recent advances in the diagnosis and treatment of MS into improved outcomes in the lives of people with MS and their families and to avoid many of the long-term economic and personal costs that result from unnecessary irreversible disability.


Clinical Trial Description

this is cross-sectional study in the Neuropsychiatry department, South Valley university hospitals, where patients with remitting relapsing multiple sclerosis according to McDonald criteria 2017 using disease modifying treatment for at least 3 months are recruited. patients were recruited from 3 major MS clinics in Assiut, South valley and Luxor. each patient was subjected to the following: - Full history and neurological examination including EDSS scores. - MRI brain and spine. - Electrophysiologic study: VEP, ABR, SSEP. - clinical scales: 1. The Arabic version of the eight-item Morisky Medication Adherence Scale (MMAS-8). 2. Treatment Satisfaction Questionnaire for Medication (TSQM-9). 3. Extended disability status scale (EDSS) measurement for MS patients 4. Hamilton depression rating-17-item version (HAM-D 17). 5. Fatigue Severity Scale (FSS) for determination of fatigue degree using the Arabic validated version 6. The Pittsburgh Sleep Quality Index (PSQI) 7. International Restless Legs Syndrome rating scale time to diagnosis and DMT initiation was calculated and the rate of adherence was determined this was followed be determining factors related to each Data analysis was done using the IBM Statistical Package for Social Sciences software package version 20.0. (Armonk, NY: IBM Corp). The qualitative variables were described with ratio and percentage. The Shapiro-Wilk test was used to verify the normality of distribution. Quantitative variables with normal distribution were reported with mean and SD, and those without normal distribution were described using median and range of mid-quartiles. The level of statistical significance was set at p < 0.05. The used tests were 1. - Chi-square test: For categorical variables, to compare between different groups 2. - Monte Carlo correction: Correction for chi-square when more than 20% of the cells have expected count less than 5 3. - Mann Whitney test: For abnormally distributed quantitative variables, to compare between two studied categories 4. - Kruskal-Wallis test: For abnormally distributed quantitative variables, to compare between more than two studied categories 5. - Regression: univariate and multivariate logistic regression for factors related to delayed diagnosis, delayed treatment initiation and non-adherence ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05438693
Study type Observational
Source Assiut University
Contact
Status Completed
Phase
Start date June 1, 2020
Completion date June 1, 2022

See also
  Status Clinical Trial Phase
Completed NCT02861014 - A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT) Phase 3
Terminated NCT01435993 - Multiple Doses of Anti-NOGO A in Relapsing Forms of Multiple Sclerosis Phase 1
Recruiting NCT05964829 - Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis N/A
Completed NCT03653585 - Cortical Lesions in Patients With Multiple Sclerosis
Completed NCT02410200 - Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS Phase 2
Completed NCT03975413 - Fecal Microbiota Transplantation (FMT) in Multiple Sclerosis
Completed NCT05080270 - Feasibility Study of Tolerogenic Fibroblasts in Patients With Refractory Multiple Sclerosis Early Phase 1
Completed NCT01116427 - A Cooperative Clinical Study of Abatacept in Multiple Sclerosis Phase 2
Completed NCT01108887 - An Observational Study for the Assessment of Adherence, Effectiveness and Convenience of Rebif® Treatment in Relapsing Multiple Sclerosis Patients Using RebiSmartâ„¢. N/A
Completed NCT01141751 - An Observational Study Comparing Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Multiple Sclerosis Quality of Life-54 Instrument (MSQOL-54) in Relapsing Multiple Sclerosis (RMS) Patients on Long-term Rebif® Therapy N/A
Completed NCT00097331 - Three Months Treatment With SB683699 In Patients With Relapsing Multiple Sclerosis Phase 2
Completed NCT01909492 - Measurement of Relaxin Peptide in Multiple Sclerosis (MS)
Completed NCT04121221 - A Study to Asses Efficacy, Safety and Tolerability of Monthly Long-acting IM Injection of GA Depot in Subjects With RMS Phase 3
Withdrawn NCT04880577 - Tenofovir Alafenamide for Treatment of Symptoms and Neuroprotection in Relapsing Remitting Multiple Sclerosis Phase 2
Not yet recruiting NCT05290688 - Cellular microRNA Signatures in Multiple Sclerosis N/A
Completed NCT04528121 - Effect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple Sclerosis N/A
Recruiting NCT04002934 - Bazedoxifene Acetate as a Remyelinating Agent in Multiple Sclerosis Phase 2
Recruiting NCT05019248 - Immune Response to Seasonal Influenza Vaccination in Multiple Sclerosis Patients Receiving Cladribine
Completed NCT04580381 - Real World Effectiveness of Natalizumab Extended Interval Dosing in a French Cohort
Completed NCT00071838 - Zenapax (Daclizumab) to Treat Relapsing Remitting Multiple Sclerosis Phase 2