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

June 25, 2022 updated by: doaa mokhtar mahmoud

Factors Affecting Time Elapsed From First Symptom Till Complete Diagnosis of Multiple Sclerosis, Initiation of Disease Modifying Treatment and Drug Adherence in Upper Egypt

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.

Study Overview

Status

Completed

Conditions

Detailed 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 Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71511
        • Assiut University
      • Qena, Egypt, 83523
        • South Valley University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to diagnosis of multiple sclerosis
Time Frame: From date of first documented MS symptom until the date of first documented diagnosis, assessed up to 10 years from onset symptoms
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 Frame: From date of first documented diagnosis until the date of first documented date of start of DMT, assessed up to 10 years from diagnosis
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
Time Frame: in the last month period prior to interview
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
determine factors related to delayed diagnosis of MS
Time Frame: From date of first documented MS symptom until the date of first documented diagnosis, assessed up to 10 years from onset symptoms

after reviewing literature, a number of factors related to delayed diagnosis of MS were determined including (age, sex, residence, education, marital status, first presenting symptom, year of presentation , first medical specialty sought and previous misdiagnosis).

the frequency of those risk factors in patients with both early and delayed diagnosis were calculated and bivariate and multivariable analysis indicated the possible independent predictive factors to the diagnostic delay
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
Time Frame: in the last month period prior to interview
the frequency of depression (using Hamilton depression scale-21), is measured and correlated to adherence. The score range from 0-50, Higher scores on this scale (>=8) are indicative of depression.
in the last month period prior to interview
frequency of fatigue as a factor related to DMT adherence
Time Frame: in the last month period prior to interview
the frequency of fatigue (using the fatigue severity scale-9), is measured and correlated to adherence. the score range from 1-63, Higher scores on this scale (>=36) are indicative of fatigue
in the last month period prior to interview
frequency of sleep disturbances as a factor related to DMT adherence
Time Frame: in the last month period prior to interview
the frequency of sleep disturbances (using Pittsburgh Sleep Quality Index), is measured and correlated to adherence. It consists of 19 self- rated questionnaires and 5 additional questionnaires for bed partner. It provides a global score of sleep on a scale from 1 to 21, with higher scores indicating more sleep complaints.
in the last month period prior to interview
treatment satisfaction as a factor related to DMT adherence
Time Frame: in the last month period prior to interview
treatment satisfaction (using Treatment Satisfaction Questionnaire for Medication-9), is measured and correlated to adherence. Questions comprise four aspects representing the personal impressions of treatment benefit, tolerability, convenience of use, and general satisfaction with the treatment. scores for each of the TSQM subscales ranged from 0 to 100. total Scores obtained were summed and the percentage of satisfaction score was calculated, where higher scores indicated higher satisfaction
in the last month period prior to interview

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

doaa mokhtar mahmoud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

June 16, 2022

First Submitted That Met QC Criteria

June 25, 2022

First Posted (Actual)

June 30, 2022

Study Record Updates

Last Update Posted (Actual)

June 30, 2022

Last Update Submitted That Met QC Criteria

June 25, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SVU MED NAP020 2 20 7 56

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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