Multiple Sclerosis Acute and ProgressiveNCT05029830
Assessment of Quality of Life and Psychological Problems in Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis Acute and Progressive, run by Assiut University at 1 site in Egypt.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Multiple Sclerosis Acute and Progressive
- What is being tested?
- investigations like MRI..
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to 30 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Adult
Study population: 1) fulfillment of either of these five categories of criteria, depending on how many clinical attacks have occurred :
Who may be able to join
- All participants must fulfill the following inclusion criteria: -
- 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.
Who cannot join
- 1) 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
Trial locations and contacts
1 site in 1 country.
About this study
- 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
- To study effect of psychiatric comorbidity on the disease activity by using clinical, laboratory and psychiometric tools.
Read the detailed description
2.1 Background (Research Question, Available Data from the literature, Current strategy for dealing with the problem, Rationale of the research that paves the way to the aim(s) of the work). (200-250 words max.) Multiple sclerosis (MS) refers to a chronic, autoimmune and demyelinating inflammatory pathology that affects the Central Nervous System (CNS) in multiple areas, namely the cerebral peduncle and periventricular areas of the brain, optic nerves, and spinal cord . MS is characterized by a diverse set of symptoms and lesions, which can cause serious physical alterations, compromise cognitive functioning, and even trigger neurological problems .
MS etiology is not yet fully understood. However, it is considered a multifactorial disease with environmental and genetic variables being risk factors with immunological implications that alter myelin (white matter) . Myelin, when degraded due to the inflammatory process inherent to the disease (flare-up), can lead to scarring (plaques/lesions) which, in turn, leads to a CNS impairment in the transmission of impulses, resulting in complications in the functioning of several organs.
The impact of MS on patients' quality of life (QoL) is undeniable. However, there are other variables whose influence are significant, such as duration of diagnosis that is associated with worse physical and mental QoL, the degree of disability, and the evolution of the disease, which also appear to be negatively associated with QoL.
Recent studies have attempted to correlate advancing neurologic disability with impaired QOL in MS patients . However, advancing neurologic disability has been shown to only partly explain impaired QOL . This supports the hypothesis that factors other than neurologic disability play a role in the QOL of MS patients.
- Conditions
- Multiple Sclerosis Acute and Progressive
- Being tested
- investigations like MRI..
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
investigations like MRI..Combination product
Also called questionnaires
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement affection quality of life in patient's with MS
Measured: 16 month
Secondary outcomes (1)
Measure psychiatric comorbidity in patients with MS
Measured: 16 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start1 Sep 2021
- Primary completion1 Sep 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis Acute and ProgressiveStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samah Ramadan, Assiut University
- Investigators
- Shady safwat, lecturer, Study director, Assiut Universitygellan karm, lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029830
- Sponsor's protocol ID
- MS
- Status last verified
- Feb 2023
- First submitted
- 16 Jun 2021
- Last updated
- 6 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30300239
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Quality of Life and Psychological Problems in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05029830
- Acronym / sponsor ID
- MS
- Conditions
- Multiple Sclerosis Acute and Progressive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
- To study effect of psychiatric comorbidity on the disease activity by using clinical, laboratory and psychiometric tools.
Detailed description
2.1 Background (Research Question, Available Data from the literature, Current strategy for dealing with the problem, Rationale of the research that paves the way to the aim(s) of the work). (200-250 words max.) Multiple sclerosis (MS) refers to a chronic, autoimmune and demyelinating inflammatory pathology that affects the Central Nervous System (CNS) in multiple areas, namely the cerebral peduncle and periventricular areas of the brain, optic nerves, and spinal cord . MS is characterized by a diverse set of symptoms and lesions, which can cause serious physical alterations, compromise cognitive functioning, and even trigger neurological problems .
MS etiology is not yet fully understood. However, it is considered a multifactorial disease with environmental and genetic variables being risk factors with immunological implications that alter myelin (white matter) . Myelin, when degraded due to the inflammatory process inherent to the disease (flare-up), can lead to scarring (plaques/lesions) which, in turn, leads to a CNS impairment in the transmission of impulses, resulting in complications in the functioning of several organs.
The impact of MS on patients' quality of life (QoL) is undeniable. However, there are other variables whose influence are significant, such as duration of diagnosis that is associated with worse physical and mental QoL, the degree of disability, and the evolution of the disease, which also appear to be negatively associated with QoL.
Recent studies have attempted to correlate advancing neurologic disability with impaired QOL in MS patients . However, advancing neurologic disability has been shown to only partly explain impaired QOL . This supports the hypothesis that factors other than neurologic disability play a role in the QOL of MS patients.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- 1) fulfillment of either of these five categories of criteria, depending on how many clinical attacks have occurred :
Key inclusion criteria (5 listed)
- All participants must fulfill the following inclusion criteria: -
Key exclusion criteria (1 listed)
- 1) 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| investigations like MRI..Also: questionnaires• 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 | Combination product | – |
Primary outcome
Measurement affection quality of life in patient's with MS
Time frame: 16 month
1 secondary outcome
Measure psychiatric comorbidity in patients with MS
Time frame: 16 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Results publication: PubMed 30300239Oh J, Vidal-Jordana A, Montalban X. Multiple sclerosis: clinical aspects. Curr Opin Neurol. 2018 Dec;31(6):752-759. doi: 10.1097/WCO.0000000000000622.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shady safwat, lecturer study director
Assiut University
gellan karm, lecturer study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis Acute and Progressive, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement affection quality of life in patient's with MS (time frame: 16 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05029830, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.