跳至主要内容
临床试验/NCT06166043
NCT06166043进行中(未招募)不适用

Evaluation of the Efficiency of the Nurse Follow-up Program Supported With Web Based Education in Managing Fatigue in Patient With Multiple Sclerosis

Istanbul University - Cerrahpasa (IUC)1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
30
试验地点
1
主要终点
Fatigue levels

研究概览

简要总结

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.

详细描述

Interventions

Groups will be determined in accordance with the randomisation method within the scope of the research for patients who voluntarily agree to participate in the research and meet the inclusion criteria. After the patient is informed about the research in accordance with the group selected, both verbal and written consent will be obtained through the "Voluntary Consent Form".

Control Group: The selected patients will first be included in the control group. Patients will be measured before the study and will receive standard care for 5 weeks without any intervention. At the end of 5 weeks, the measurements of the patients will be repeated. Patients will then be included in the case group. Fatigue Severity Scale, Pittsburg Sleep Quality Scale, EQ5D Quality of Life Scale will be applied to the patients at the beginning and after 5 weeks of receiving standard care.

Case Group: The case group will be included in a 5-week programme including a web-based training programme and nurse follow-up system. This training package, which is determined as 2 days a week for 5 weeks and each session will last 50 minutes, will be carried out through the zoom programme because it is easy to use and adapt. The content of the training is based on fatigue management, taking into account the relevant factors in parallel with the literature. Before the training starts, the patients will be fitted with a smart watch and their step counts and sleep patterns (sleep time, what time they go to bed, deep sleep and light sleep hours) will be monitored for 7 days and this information will be obtained from the patient on a daily basis. They will be informed that they should never take the watch off their wrists and make sure that it works in a healthy way. At the same time, the watch of the researcher and the watch of the participants will be matched to make sure that the watches of the patients are working and measuring simultaneously. Fatigue Severity Scale, Pittsburg Sleep Quality Scale, EQ5D Quality of Life Scale will be applied to the patients. In order to see the behavioural change more clearly after the end of the training, the clock measurements of the patients will be recorded again for 7 days after 1 month and the specified scales will be applied again. At 3 and 6 months, only the scales will be applied again.

Web-based Education Programme After the interviews with the patients, a day and time suitable for the patients will be determined.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Fatigue levels

时间窗: 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.

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.

次要结局

  • sleep quality levels(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.)
  • quality of life levels(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.)

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

GİZEM YAĞMUR YALÇIN

Principal Investigator

Istanbul University - Cerrahpasa (IUC)

研究点 (1)

Loading locations...

相似试验