Skip to main content
OpenTrials
Completed

NCT Number: NCT04758494

Quality of Life Assessment Between Stroke and Multiple Sclerosis Patients of the Same Age Range

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Anxiety Disorders Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Depression Immune System Diseases Mental Disorders Mental Health Disorder Multiple Sclerosis Nervous System Diseases Personal Satisfaction Psychological Well-Being Quality of Life Vascular Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Vascular Surgery, Hellenic Red Cross Hospital

Athens, 11526, Greece

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

In the present study a questionnaire was designed by combining three separate questionnaires, which were weighted for use in Greek population and which are often being used to investigate quality of life of young populations diagnosed with stroke or multiple sclerosis, according to international literature. Those were the following questionnaires: Bathrel (Mahoney et al), Patient Health Questionairre (PHQ-9) (Thomson K et al), Health Survey SF-12 (Kontodinopoulos et al 2007). A draft questionnaire was then created with the addition of questions deemed necessary to provide necessary research information. Overall the questionnaire consisted of 42 questions.

Part A The first part of the questionnaire included demographics of participants. Part B. The second part of the questionnaire included an assessment of the functionality and independence, an evaluation of experienced depression and an assessment of the quality of life of the target population.

Primary outcomes

  1. Barthel score

    Time frame: Through study completion, an average of 1 year

    The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored from 0 (total dependence) up to 3 (total independence), a higher number being a reflection of greater ability to function independently following hospital discharge.Time taken and physical assistance required to perform each item are used in determining the assigned value of each item. The Barthel Index measures the degree of assistance required by an individual on 10 items of mobility and self care ADL (lowest score=0, highest score=20).

  2. PHQ-9 score

    Time frame: Through study completion, an average of 1 year

    The Patient Health Questionnaire-9 (PHQ-9) is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The tool rates the frequency of the symptoms which factors into the scoring severity index. Question 9 on the PHQ-9 screens for the presence and duration of suicide ideation. A follow up, non-scored question on the PHQ-9 screens and assigns weight to the degree to which depressive problems have affected the patient's level of function. The PHQ-9 is brief and useful in clinical practice. The PHQ-9 is completed by the patient in minutes and is rapidly scored by the clinician. The higher the total score, the worse the depression the patient exhibits. Minimum score=0 indicates absence of depression, and maximum score=27 indicates severe depression. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.

  3. SF12-physical component summary (PCS) score

    Time frame: Through study completion, an average of 1 year

    The Short Form-12 (SF-12) is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. The SF-12 is a shortened version of it's predecessor, the SF-36, which itself evolved from the Medical Outcomes Study. It consists of 12 items, each one scored in a given scale. Each item's scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. Two subscales are derived from the SF-12: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The physical component of SF-12 measures physical functioning, role limitations due to physical health problems, bodily pain, general health, and vitality (energy/fatigue).

  4. SF12-mental component summary (MCS) score

    Time frame: Through study completion, an average of 1 year

    The Short Form-12 (SF-12) is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. The SF-12 is a shortened version of it's predecessor, the SF-36, which itself evolved from the Medical Outcomes Study. It consists of 12 items, each one scored in a given scale. Each item's scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. Two subscales are derived from the SF-12: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The mental component of SF-12 measures social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being).

  5. Depression severity level

    Time frame: Through study completion, an average of 1 year

    Depression severity was assessed according to Patient Health Questionnaire-9 (PHQ-9) score from 0-27 (see above) and then characterized by using five distinctive levels, namely: None (0-4), Mild (5-9), Moderate (10-14), Moderate severe (15-19) and Severe (20-27).

  6. Dependency category

    Time frame: Through study completion, an average of 1 year

    Categorization of patient dependency was done according to Barthel score from 0-100 (see above) by using four distinctive categories, namely: Total (0-20), Severe (21-60), Moderate (61-90) and Slight (91-100).

Sponsors and collaborators

Lead sponsor

Hellenic Red Cross Hospital

Other

Collaborators

  • G.Gennimatas General Hospital

Registry information

Official study title

A Study to Assess Quality of Life in Stroke and Multiple Sclerosis Patients of the Same Age Range

Acronym: QoLSMS

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 17, 2021
Registry last updated
Feb 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.