NCT05029830

Brief Summary

  1. 1.use QoL assessments to check whether interventions have been as effective from the patient's point of view as from the clinician's, and to determine whether further action is required . Knowledge of which factors are determinants of QoL in patients with MS would assist clinicians in choosing the most appropriate interventions. Several determinants of QoL have been identified with varying strengths of association and include both disease-related variables (disability status ,disease duration ,fatigue ,depression ,cognition , sociodemographic variables (age and sex ,level of education, and marital status . A number of these factors might be amenable to treatment intervention, which might be expected to improve QoL: fatigue , depression , and cognition
  2. 2.To study effect of psychiatric comorbidity on the disease activity by using clinical, laboratory and psychiometric tools.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

June 16, 2021

Last Update Submit

February 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Measurement affection quality of life in patient's with MS

    16 month

Secondary Outcomes (1)

  • Measure psychiatric comorbidity in patients with MS

    16 month

Interventions

investigations like MRI..COMBINATION_PRODUCT

• Multiple Sclerosis Quality of Life-54 (MSQOL-54) Can be considered as the most known disease-specific instrument for the evaluation of quality of life in patients with multiple sclerosis (MS). It was developed to combine generic quality of life aspects of the SF-36 with MS-targeted dimensions and ratings for the overall quality of life. Therefore, 18 disease-specific items were added to the original 36 items of the SF-36. The 54 items are divided into 12 multi-item and 2 single-item scales. The MSQOL-54 items are transformed linearly to 0-100 scores and final scores are obtained by averaging items within the scales

Also known as: questionnaires

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

1\) fulfillment of either of these five categories of criteria, depending on how many clinical attacks have occurred :

You may qualify if:

  • fulfillment of either of these five categories of criteria, depending on how many clinical attacks have occurred
  • patients aged 18 to 40 years of age.
  • Males and females are included.
  • All patients who received diagnosis of multiple sclerosis whether under treatment or not.

You may not qualify if:

  • \) Patients age of below 18 years or over 40 years . 2) History suggestive or diagnosed collagen disease such as Bechet disease. 3) History suggestive with other general medical disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samah

Asyut, Egypt

Location

Related Publications (1)

  • Oh J, Vidal-Jordana A, Montalban X. Multiple sclerosis: clinical aspects. Curr Opin Neurol. 2018 Dec;31(6):752-759. doi: 10.1097/WCO.0000000000000622.

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Shady safwat, lecturer

    Assiut University

    STUDY DIRECTOR
  • gellan karm, lecturer

    Assiut University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

June 16, 2021

First Posted

September 1, 2021

Study Start

September 1, 2021

Primary Completion

September 1, 2022

Study Completion

October 30, 2022

Last Updated

February 6, 2023

Record last verified: 2023-02

Locations