Delayed Diagnosis of Multiple Sclerosis, Treatment Initiation and Non-adherence in Upper Egypt

NCT05438693 | Completed

• 1 other identifier: SVU MED NAP020 2 20 7 56
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Outcome Measures

Primary Outcomes (3)

• time to diagnosis of multiple sclerosis

  time to MS diagnosis is measured from the date of the first symptom till the date of the official diagnosis of MS

  From date of first documented MS symptom until the date of first documented diagnosis, assessed up to 10 years from onset symptoms

• time to disease modifying treatment initiation

  time to DMT initiation is calculated from the date of diagnosis till the date the patient first received the prescribed DMT

  From date of first documented diagnosis until the date of first documented date of start of DMT, assessed up to 10 years from diagnosis

• rate of adherence to disease modifying treatment among MS patients

  the rate of adherence to DMT among MS patients is measured by Morinski medical adherence scale for medications. with a score of 8 is considered adherent while \<8 is considered non-adherent.

  in the last month period prior to interview

Secondary Outcomes (5)

• determine factors related to delayed diagnosis of MS

  From date of first documented MS symptom until the date of first documented diagnosis, assessed up to 10 years from onset symptoms

• frequency of depression as a factor related to DMT adherence

  in the last month period prior to interview

• frequency of fatigue as a factor related to DMT adherence

  in the last month period prior to interview

• frequency of sleep disturbances as a factor related to DMT adherence

  in the last month period prior to interview

• treatment satisfaction as a factor related to DMT adherence

  in the last month period prior to interview

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Eighty patients diagnosed with remitting relapsing MS and on DMTs were included in the study. MS was diagnosed based on the clinical examination, magnetic resonance imaging (MRI), lumbar puncture (LP), and visual evoked potential (VEP) using McDonald criteria. They were included according to the previous inclusion and exclusion criteria. all cases were interviewed and examined by a neurologist and the following data were retrospectively collected: demographic, clinical data, therapeutic history, complete clinical examination including EDSS score, radiological data, electrophysiological tests results and clinical scales including: MMAS-8, TSQM-9, PSQI, IRLS and FSS

You may qualify if:

• Patient with confirmed diagnosis of remitting relapsing multiple sclerosis according to the 2017 McDonald's criteria and receiving any DMT for at least 3 months.

You may not qualify if:

• Presence of any clinical or radiological finding suggesting a diagnosis other than MS or other demyelinating diseases.
• Presence of other systemic disease or being on long term treatment for any disease.
• Incomplete clinical or radiological data were provided.
• Subject declined to provide written informed consent.

Sponsors & Collaborators

• doaa mokhtar mahmoud: lead

Study Sites (2)

South valley University

Qina, Qena Governorate, 83523, Egypt

Location

Assiut University

Asyut, 71511, Egypt

Location

Related Publications (11)

• Koch-Henriksen N, Sorensen PS. The changing demographic pattern of multiple sclerosis epidemiology. Lancet Neurol. 2010 May;9(5):520-32. doi: 10.1016/S1474-4422(10)70064-8.

  PMID: 20398859 BACKGROUND

• Giovannoni G, Butzkueven H, Dhib-Jalbut S, Hobart J, Kobelt G, Pepper G, Sormani MP, Thalheim C, Traboulsee A, Vollmer T. Brain health: time matters in multiple sclerosis. Mult Scler Relat Disord. 2016 Sep;9 Suppl 1:S5-S48. doi: 10.1016/j.msard.2016.07.003. Epub 2016 Jul 7.

  PMID: 27640924 BACKGROUND

• Gaitan MI, Correale J. Multiple Sclerosis Misdiagnosis: A Persistent Problem to Solve. Front Neurol. 2019 May 7;10:466. doi: 10.3389/fneur.2019.00466. eCollection 2019. No abstract available.

  PMID: 31133970 BACKGROUND

• Kaufmann M, Kuhle J, Puhan MA, Kamm CP, Chan A, Salmen A, Kesselring J, Calabrese P, Gobbi C, Pot C, Steinemann N, Rodgers S, von Wyl V; Swiss Multiple Sclerosis Registry (SMSR). Factors associated with time from first-symptoms to diagnosis and treatment initiation of Multiple Sclerosis in Switzerland. Mult Scler J Exp Transl Clin. 2018 Dec 6;4(4):2055217318814562. doi: 10.1177/2055217318814562. eCollection 2018 Oct-Dec.

  PMID: 30559972 BACKGROUND

• McNicholas N, Hutchinson M, McGuigan C, Chataway J. 2017 McDonald diagnostic criteria: A review of the evidence. Mult Scler Relat Disord. 2018 Aug;24:48-54. doi: 10.1016/j.msard.2018.05.011. Epub 2018 Jun 21.

  PMID: 29936325 BACKGROUND

• Ashur ST, Shamsuddin K, Shah SA, Bosseri S, Morisky DE. Reliability and known-group validity of the Arabic version of the 8-item Morisky Medication Adherence Scale among type 2 diabetes mellitus patients. East Mediterr Health J. 2015 Dec 13;21(10):722-8. doi: 10.26719/2015.21.10.722.

  PMID: 26750162 BACKGROUND

• Vermersch P, Hobart J, Dive-Pouletty C, Bozzi S, Hass S, Coyle PK. Measuring treatment satisfaction in MS: Is the Treatment Satisfaction Questionnaire for Medication fit for purpose? Mult Scler. 2017 Apr;23(4):604-613. doi: 10.1177/1352458516657441. Epub 2016 Jul 11.

  PMID: 27364322 BACKGROUND

• Hamilton M. Development of a rating scale for primary depressive illness. Br J Soc Clin Psychol. 1967 Dec;6(4):278-96. doi: 10.1111/j.2044-8260.1967.tb00530.x. No abstract available.

  PMID: 6080235 BACKGROUND

• Al-Sobayel HI, Al-Hugail HA, AlSaif RM, Albawardi NM, Alnahdi AH, Daif AM, Al-Arfaj HF. Validation of an Arabic version of Fatigue Severity Scale. Saudi Med J. 2016 Jan;37(1):73-8. doi: 10.15537/smj.2016.1.13055.

  PMID: 26739978 BACKGROUND

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

  PMID: 2748771 BACKGROUND

• Shalash AS, Elrassas HH, Monzem MM, Salem HH, Abdel Moneim A, Moustafa RR. Restless legs syndrome in Egyptian medical students using a validated Arabic version of the Restless Legs Syndrome Rating Scale. Sleep Med. 2015 Dec;16(12):1528-31. doi: 10.1016/j.sleep.2015.07.032. Epub 2015 Sep 25.

  PMID: 26611951 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 30, 2022
• Study Start: June 1, 2020
• Primary Completion: April 30, 2022
• Study Completion: June 1, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)