NCT04100343

Brief Summary

Each Multiple Sclerosis patient will be submitted to Cognitive Abilities Screening Instrument (CASI), Expanded Disability Status Scale, Epowrth Sleeping Scale(ESS),Fatigue Severity Scale(FSS), Hamilton Depression Rating Scale, Hamilton Anxiety Rating Scale, Headache Disability Index, specific questionnaire based on International Headache Society (IHS) recommendations

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Status
unknown

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

September 17, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

October 4, 2019

Status Verified

October 1, 2019

Enrollment Period

2.1 years

First QC Date

September 17, 2019

Last Update Submit

October 2, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fatigue severity scale

    A self-report scale of nine items about fatigue, its severity and how it affects certain activities. Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63. The higher the score, the more severe the fatigue is and the more it affects the person's activities. It is simple to understand and takes an average of eight minutes to answer

    1 year

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study will include all patients daignosed as multiple sclerosis attending at Assiut university hospital within the prescribed time

You may qualify if:

  • Male or female.
  • Age:30-50 years
  • Accepting all study requirement

You may not qualify if:

  • comorbid patient e.g (diabetic, hypertensive.......etc )
  • opposition of the patient or their family

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mahmood M. Yosry Abdelsatar

Study Record Dates

First Submitted

September 17, 2019

First Posted

September 24, 2019

Study Start

November 1, 2019

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

October 4, 2019

Record last verified: 2019-10