Stroke Clinical Trial
— QoLSMSOfficial title:
A Study to Assess Quality of Life in Stroke and Multiple Sclerosis Patients of the Same Age Range
Verified date | February 2021 |
Source | Hellenic Red Cross Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 172 |
Est. completion date | November 10, 2020 |
Est. primary completion date | November 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Greece | Department of Vascular Surgery, Hellenic Red Cross Hospital | Athens |
Lead Sponsor | Collaborator |
---|---|
Hellenic Red Cross Hospital | G.Gennimatas General Hospital |
Greece,
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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. — View Citation
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. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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