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

NCT ID: NCT04758494

Last Updated: 2021-02-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 172 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-11
• Study Completion Date: 2020-11-10

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?

Conditions

Stroke; Multiple Sclerosis; Quality of Life; Depression; Mental Health Disorder

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

Stroke1-hemiparesis

Patients diagnosed with an ischemic/hemorrhagic stroke and clinical hemiparesis.

Questionnaire

Intervention Type: 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.

Stroke 2-mild stroke

Patients diagnosed with an ischemic/hemorrhagic stroke and clinical symptoms of a mild stroke.

Questionnaire

Intervention Type: 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.

Stroke 3-speech disorder

Patients diagnosed with an ischemic/hemorrhagic stroke and clinical symptoms of a speech disorder.

Questionnaire

Intervention Type: 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.

Stroke 4-hemiparesis mainly of upper limb

Patients diagnosed with an ischemic/hemorrhagic stroke and clinical hemiparesis mainly of upper limb.

Questionnaire

Intervention Type: 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.

Stroke 5-memory loss and depression

Patients diagnosed with an ischemic/hemorrhagic stroke and clinical symptoms of memory loss and depression.

Questionnaire

Intervention Type: 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.

Multiple Sclerosis

Patients diagnosed with multiple sclerosis.

Questionnaire

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

G.Gennimatas General Hospital

OTHER

Sponsor Role: collaborator

Hellenic Red Cross Hospital

OTHER

Sponsor Role: lead

Responsible Party

Konstantinos Roditis, MD, MSc

Chief Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Konstantinos Roditis, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

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

Theofanis T Papas, MD, MSc, PhD

Role: STUDY_DIRECTOR

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

Nikolaos Bessias, MD, MSc, PhD

Role: STUDY_CHAIR

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

Locations

Department of Vascular Surgery, Hellenic Red Cross Hospital

Athens, , Greece

Countries

Greece

References

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Reference Type: BACKGROUND

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Thompson K, D'iuso D, Schwartzman D, Dobson KS, Drapeau M. Changes in depressed patients' self-statements. Psychother Res. 2020 Feb;30(2):170-182. doi: 10.1080/10503307.2018.1543976. Epub 2018 Nov 13.

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Other Identifiers

3320/06-02-2020

Identifier Type: OTHER

Identifier Source: secondary_id

257/19-12-2019

Identifier Type: -

Identifier Source: org_study_id