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临床试验/NCT06286072
NCT06286072招募中不适用

The Effect of Education and Reminder Messages on the Fatigue Level of Individuals With COPD: Randomised Controlled Study

Kirsehir Ahi Evran Universitesi1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Fatigue Level

研究概览

简要总结

COPD is an important respiratory system disease that progresses with damage to the airways.Increased mucus secretion and thickening in the airways causes obstruction.This obstruction causes symptoms such as shortness of breath, cough, phlegm and wheezing.The most obvious problem that the emerging symptoms will cause for the patient is fatigue.Coping with fatigue is an important problem in COPD.

The main questions it aims to answer are:

  1. Does the training given in COPD affect the level of fatigue?
  2. Do the education given and text messages sent regarding COPD affect the level of fatigue?

In this study, patients were given informative education about COPD and ways to cope with fatigue were explained. Then, in order to increase the permanence of the training, motivational messages and short briefings were continued for 8 weeks.2 messages were sent per week. Three groups were created to reveal the effectiveness of the trainings and messages.

Group 1 was trained and messages were sent for 8 weeks. Group 2 was trained and no message was sent. Group 3 is the control group. No training has been provided other than routine maintenance.

The initial information of all groups was taken again at the end of the 8th week.

Main outcomes:

  • Dyspnea severity,
  • COPD general conditions and
  • Fatigue level. The results obtained will be interpreted by comparing between 3 groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosed with COPD for the last 1 year
  • •Hospitalized for at least 3 days,
  • •Voluntary patients

排除标准

  • •Under 18 years old
  • •Over 85 years old
  • •Those with chronic fatigue syndrome
  • •Those with severe heart failure
  • •Those who had surgery in the last 6 months

研究组 & 干预措施

Training and Message Group

Experimental

Patients in this group were given training for 3 consecutive days during their stay in the hospital.

Day 1: general information about the disease, medication use Day 2: Physiology of fatigue, factors causing fatigue, and the relationship between COPD and fatigue.

Day 3 Strategies to cope with fatigue (Breathing exercises, good thinking, etc.)

Patients were messaged twice a week after they were discharged. Message sent for 8 weeks. Short, motivating and reminder messages were used. For example;

  • When I can control my shortness of breath, my fatigue level decreases significantly.
  • Excessive thinking and stress lead to more fatigue. That's why I stay away from negative thoughts.

At the baseline and 8th weeks, the patients were interviewed again and their dyspnea and fatigue levels were measured again.

干预措施: Education and message (Other)

Training Group

Experimental

Patients in this group were given training for 3 consecutive days during their stay in the hospital.

Day 1: general information about the disease, medication use Day 2: Physiology of fatigue, factors causing fatigue, and the relationship between COPD and fatigue.

Day 3 Strategies to cope with fatigue (Breathing exercises, good thinking, etc.)

No other treatment was performed on these patients.

At the baseline and end of 8 weeks, the patients were interviewed again and their dyspnea and fatigue levels were measured again.

干预措施: Education and message (Other)

Routine Treatment and Care Group

Active Comparator

These patients received routine treatment and care in the clinic. No training was given. Message not sent.

At the baseline and 8th weeks, the patients were interviewed again and their dyspnea and fatigue levels were measured again.

干预措施: Education and message (Other)

结局指标

主要结局

Fatigue Level

时间窗: Applied at baseline and after 8 weeks.

Evaluated with COPD ASTHMA FATIGUE SCALE.

Dyspnea Severity

时间窗: Applied at baseline and after 8 weeks.

Evaluated with mMRC Dyspnea Scale

次要结局

  • COPD general condition(Applied at baseline and after 8 weeks.)

研究者

发起方
Kirsehir Ahi Evran Universitesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasemin CEYHAN

Assistant Proffesor

Kirsehir Ahi Evran Universitesi

研究点 (1)

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