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

February 12, 2021 updated by: Konstantinos Roditis, MD, MSc, Hellenic Red Cross Hospital

A Study to Assess Quality of Life in 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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?

Study Type

Observational

Enrollment (Actual)

172

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 11526
        • Department of Vascular Surgery, Hellenic Red Cross Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Stroke1-hemiparesis
Patients diagnosed with an ischemic/hemorrhagic stroke and clinical hemiparesis.
Other: Questionnaire

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.
Stroke 2-mild stroke
Patients diagnosed with an ischemic/hemorrhagic stroke and clinical symptoms of a mild stroke.
Other: Questionnaire

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.
Stroke 3-speech disorder
Patients diagnosed with an ischemic/hemorrhagic stroke and clinical symptoms of a speech disorder.
Other: Questionnaire

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.
Stroke 4-hemiparesis mainly of upper limb
Patients diagnosed with an ischemic/hemorrhagic stroke and clinical hemiparesis mainly of upper limb.
Other: Questionnaire

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.
Stroke 5-memory loss and depression
Patients diagnosed with an ischemic/hemorrhagic stroke and clinical symptoms of memory loss and depression.
Other: Questionnaire

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.
Multiple Sclerosis
Patients diagnosed with multiple sclerosis.
Other: Questionnaire

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
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).
Through study completion, an average of 1 year
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).
Through study completion, an average of 1 year
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).
Through study completion, an average of 1 year
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).
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hellenic Red Cross Hospital

Collaborators

G.Gennimatas General Hospital

Investigators

  • Principal Investigator: Konstantinos Roditis, MD, MSc, Department of Vascular Surgery, Hellenic Red Cross Hospital, Athens, Greece
  • Study Director: Theofanis T Papas, MD, MSc, PhD, Department of Vascular Surgery, Hellenic Red Cross Hospital, Athens, Greece
  • Study Chair: Nikolaos Bessias, MD, MSc, PhD, Department of Vascular Surgery, Hellenic Red Cross Hospital, Athens, Greece

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2019

Primary Completion (Actual)

November 10, 2020

Study Completion (Actual)

November 10, 2020

Study Registration Dates

First Submitted

February 9, 2021

First Submitted That Met QC Criteria

February 12, 2021

First Posted (Actual)

February 17, 2021

Study Record Updates

Last Update Posted (Actual)

February 17, 2021

Last Update Submitted That Met QC Criteria

February 12, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 257/19-12-2019
  • 3320/06-02-2020 (Other Identifier: Hellenic Red Cross Hospital Administratory Board)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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