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

NCT04758494 | Completed

• 2 other identifiers: 257/19-12-20193320/06-02-2020
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• Barthel score

  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

  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

  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

  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

  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

  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

Study Arms (6)

Stroke1-hemiparesis

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

Other: Questionnaire

Stroke 2-mild stroke

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

Other: Questionnaire

Stroke 3-speech disorder

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

Other: Questionnaire

Stroke 4-hemiparesis mainly of upper limb

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

Other: Questionnaire

Stroke 5-memory loss and depression

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

Other: Questionnaire

Multiple Sclerosis

Patients diagnosed with multiple sclerosis.

Other: Questionnaire

Interventions

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.

Multiple Sclerosis; Stroke 2-mild stroke; Stroke 3-speech disorder; Stroke 4-hemiparesis mainly of upper limb; Stroke 5-memory loss and depression; Stroke1-hemiparesis

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hellenic Red Cross Hospital: lead
• G.Gennimatas General Hospital: collaborator

Study Sites (1)

Department of Vascular Surgery, Hellenic Red Cross Hospital

Athens, 11526, Greece

Location

Related Publications (7)

• MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.

  PMID: 14258950 BACKGROUND

• WYLIE CM, WHITE BK. A MEASURE OF DISABILITY. Arch Environ Health. 1964 Jun;8:834-9. doi: 10.1080/00039896.1964.10663764. No abstract available.

  PMID: 14157579 BACKGROUND

• Imhof L, Suter-Riederer S, Kesselring J. Effects of Mobility-Enhancing Nursing Intervention in Patients with MS and Stroke: Randomised Controlled Trial. Int Sch Res Notices. 2015 Feb 17;2015:785497. doi: 10.1155/2015/785497. eCollection 2015.

  PMID: 27347547 BACKGROUND

• Altura KC, Patten SB, Fiest KM, Atta C, Bulloch AG, Jette N. Suicidal ideation in persons with neurological conditions: prevalence, associations and validation of the PHQ-9 for suicidal ideation. Gen Hosp Psychiatry. 2016 Sep-Oct;42:22-6. doi: 10.1016/j.genhosppsych.2016.06.006. Epub 2016 Jul 5.

  PMID: 27638967 BACKGROUND

• Hausmann J, Sweeney-Reed CM, Sobieray U, Matzke M, Heinze HJ, Voges J, Buentjen L. Functional electrical stimulation through direct 4-channel nerve stimulation to improve gait in multiple sclerosis: a feasibility study. J Neuroeng Rehabil. 2015 Nov 14;12:100. doi: 10.1186/s12984-015-0096-3.

  PMID: 26577467 BACKGROUND

• Yoo SH, Kim SR, So HS, Chung HC, Chae DH, Kim MK, Kim BC, Park MS, Lee SH, Nam TS, Correia H, Cella D. The Validity and Reliability of the Korean Version of the Stigma Scale for Chronic Illness 8-Items (SSCI-8) in Patients with Neurological Disorders. Int J Behav Med. 2017 Apr;24(2):288-293. doi: 10.1007/s12529-016-9593-4.

  PMID: 27900731 BACKGROUND

• 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.

  PMID: 30422103 BACKGROUND

MeSH Terms

Conditions

Stroke; Multiple Sclerosis; Depression; Mental Disorders; Psychological Well-Being; Anxiety Disorders; Nervous System Diseases

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Konstantinos Roditis, MD, MSc

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

  PRINCIPAL INVESTIGATOR

• Theofanis T Papas, MD, MSc, PhD

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

  STUDY DIRECTOR

• Nikolaos Bessias, MD, MSc, PhD

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Resident

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 17, 2021
• Study Start: November 11, 2019
• Primary Completion: November 10, 2020
• Study Completion: November 10, 2020
• Last Updated: February 17, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)