Multiple Sclerosis Clinical Trial
Official title:
Evaluation of the Efficiency of the Nurse Follow-up Program Supported With Web Based Education in Managing Fatigue in Patient With Multiple Sclerosis
Verified date | December 2023 |
Source | Istanbul University - Cerrahpasa (IUC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The research will be carried out as a randomized controlled experimental study to examine the effect of a nursing support program supported by a Web-based education program on the management of fatigue symptoms of patients who are under treatment and care in the Multiple Sclerosis clinic of a university hospital.Patients will receive 5 weeks of standard care. At the end of 5 weeks, they will enter a training program. After this online training program, which will be 5 weeks and 2 sessions per week, the change in the patients' fatigue, sleep quality and quality of life will be analyzed.
Status | Active, not recruiting |
Enrollment | 30 |
Est. completion date | March 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Being diagnosed with MS according to McDonald diagnostic criteria at least 6 months ago Being over 18 years old Having voluntarily agreed to participate in the study Having a score below 18 points from the depression tests (Beck Depression Scale), EDSS score <5 Exclusion Criteria: - Presence of a diagnosed psychological illness Having had an attack in the last 3 months Having a score below 24 points in the Mini Mental test evaluation The patient's heart failure Having thyroid hormone imbalance Having uncontrolled and unfollowed anemia |
Country | Name | City | State |
---|---|---|---|
Turkey | Gizem Yagmur Yalçin | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Istanbul University - Cerrahpasa (IUC) |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fatigue levels | Fatigue levels of the patients will be measured before and after the education.Patients' fatigue levels will be measured using the fatigue severity scale. The scale consists of 9 items. It is a scale that the patient can fill in themself. | The first measurements are made on the patients included in the study. After 5 weeks, the same measurements are made again. The same measurements are made for the patients included in the training 9 weeks and 17 weeks after the start of the training. | |
Secondary | sleep quality levels | The sleep quality of the patients will be evaluated with the Pittsburg sleep quality scale, which is a 24-item scale in total. Each item in the scale is scored between 0-3 and the total score varies between 0-21. A total PDQI score greater than five indicates that the sleep quality of the individual is inadequate. | The first measurements are made on the patients included in the study. After 5 weeks, the same measurements are made again. The same measurements are made for the patients included in the training 9 weeks and 17 weeks after the start of the training. | |
Secondary | quality of life levels | The EQ-5D quality of life scale will be used to measure quality of life. The EQ-5D was developed by the EuroQol Group, an international, interdisciplinary group established in 1987 to investigate issues related to the assessment of health. It has been translated into more than 60 languages and is used worldwide. The reliability and validity of the EQ-5D has been established both in general (Brooks & De Charro, 1996) and in disease-specific groups (Ă–ster et al., 2009; Schrag et al., 2000; Schweikert et al., 2006).
The EQ-5D descriptive system includes five questions covering five dimensions: mobility, self-care, usual activities, pain and anxiety/depression. For each dimension, participants rate their health by reporting whether they experience 1 = "none", 2 = "moderate" or 3 = "extreme problems".Participants receive a score between 0.59 and 1. The higher the score, the better the quality of life. |
The first measurements are made on the patients included in the study. After 5 weeks, the same measurements are made again. The same measurements are made for the patients included in the training 9 weeks and 17 weeks after the start of the training. |
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