Clinical trial NCT04758494: Quality of Life Assessment Between Stroke and Multiple Sclerosis Patients of the Same Age Range
Official title: A Study to Assess Quality of Life in Stroke and Multiple Sclerosis Patients of the Same Age Range
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Multiple Sclerosis
Quality of Life
Depression
Mental Health Disorder
Keywords: stroke
multiple sclerosis
quality of life
mental health
depression
anxiety
well-being
wellness
neurological disorder
Lead sponsor: Hellenic Red Cross Hospital
Sponsor class: OTHER
Collaborators: name: G.Gennimatas General Hospital
First posted: 2021-02-17
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: In the present study the sample were patients with ischemic or hemorrhagic stroke or multiple sclerosis (regardless of EDSS).

All participants belonged to the age group 18-60, ie they reflected the usual age when the person is professionally active in most parts of the world. These are, after all, the age limits used by the World Health Organization.

The sample was randomly selected through stratification with representation of patients based on gender, age category and geographical location. Data on age, sex, race, marital status, occupation, educational level, plus morbidity, were identified from medical records and self-reports.

Brief summary: The purpose of this study is to investigate the physical, psychological, social and functional aspects of life in relatively young people suffering from vascular stroke and in people diagnosed with multiple sclerosis of the same age group and to generally assess the subjective perception of these patients about their general health and well-being. In addition, to assess the degree of depression experienced by people in this age group who suffer from these diseases. Additional objectives are to investigate important factors that negatively affect the quality of life in this group of patients, according to the international literature, and to highlight targeted interventions to promote mental and physical health in order to improve the quality of life in these chronic patients.

Detailed description: Research on the importance of quality of life in chronic neurological patients has occasionally occupied the international scientific community. Due to the large scale of strokes occurring at young ages as well as multiple sclerosis, more and more research is focusing on the quality of life of these individuals.

The present study is retrospective as well as prospective. The purpose of this study is to investigate the physical, psychological, social and functional aspects of life in relatively young people suffering from vascular stroke and in people diagnosed with multiple sclerosis of the same age group and to generally assess the subjective perception of these patients about their general health and well-being. In addition, to assess the degree of depression experienced by people in this age group who suffer from these diseases. Additional objectives are to investigate important factors that negatively affect the quality of life in this group of patients, according to the international literature, and to highlight targeted interventions to promote mental and physical health in order to improve the quality of life in these chronic patients.

In particular, the research questions that this study is trying to answer are:

* Do young stroke patients exhibit the same quality of life as healthy populations of the same age?
* Do young people with multiple sclerosis have the same quality of life as the healthy population of the same age?
* Do young people with stroke have the same quality of life as patients with multiple sclerosis of the same age?
* Are patients (either with multiple sclerosis or stroke) with almost the same degree of physical independence and are older patients characterized by greater depression and reduced quality of life compared to younger ones?
* Is degree of disability associated with decreased quality of life and increased depression between the two groups of chronic patients?
* Does gender affect the quality of life and the presence of depression?
* Do marital and economic status affect the indicators of depression and quality of life in both populations to be investigated?
* Is location of living a factor that contributes to the reduced quality of life and the triggering of depression in young people with stroke and multiple sclerosis compared to the healthy population?

Eligibility criteria: Inclusion Criteria:

* Greek citizenship
* Age 18-60 years
* Hospitalization at the department of Neurology, G. Gennimatas Hospital or at the department of Vascular Surgery and/or Neurosurgery, Hellenic Red Cross Hospital
* Diagnosis of ischemic or hemorrhagic stroke or multiple sclerosis at discharge from hospital

Exclusion Criteria:

* Alien citizenship
* Age below 18 or above 60 years
* Mental or physical disability history before the diagnosis of stroke or multiple sclerosis
* Second stroke during the period of the study
* History of dementia
* Symptoms of aphasia or individuals in comatose state (high NIHS)
* Individuals with stroke in the frontal lobe

Primary outcomes:
measure: Barthel score
timeFrame: Through study completion, an average of 1 year
measure: PHQ-9 score
timeFrame: Through study completion, an average of 1 year
measure: SF12-physical component summary (PCS) score
timeFrame: Through study completion, an average of 1 year
measure: SF12-mental component summary (MCS) score
timeFrame: Through study completion, an average of 1 year
measure: Depression severity level
timeFrame: Through study completion, an average of 1 year
measure: Dependency category
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Department of Vascular Surgery, Hellenic Red Cross Hospital
Study officials:
affiliation: Department of Vascular Surgery, Hellenic Red Cross Hospital, Athens, Greece
name: Konstantinos Roditis, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Vascular Surgery, Hellenic Red Cross Hospital, Athens, Greece
name: Theofanis T Papas, MD, MSc, PhD
role: STUDY_DIRECTOR
affiliation: Department of Vascular Surgery, Hellenic Red Cross Hospital, Athens, Greece
name: Nikolaos Bessias, MD, MSc, PhD
role: STUDY_CHAIR
References:
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