The Effect of Education and Reminder Messages on the Fatigue Level of Individuals With COPD

August 6, 2024 updated by: Yasemin CEYHAN, Kirsehir Ahi Evran Universitesi

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Training and Message Group

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.
Other: Education and message
COPD general education content and fatigue-specific coping strategies. Messages sent to phones
Experimental: Training Group

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.
Other: Education and message
COPD general education content and fatigue-specific coping strategies. Messages sent to phones
Active Comparator: Routine Treatment and Care Group

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.
Other: Education and message
COPD general education content and fatigue-specific coping strategies. Messages sent to phones

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatigue Level
Time Frame: Applied at baseline and after 8 weeks.
Evaluated with COPD ASTHMA FATIGUE SCALE.
Applied at baseline and after 8 weeks.
Dyspnea Severity
Time Frame: Applied at baseline and after 8 weeks.
Evaluated with mMRC Dyspnea Scale
Applied at baseline and after 8 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COPD general condition
Time Frame: Applied at baseline and after 8 weeks.
Evaluated with COPD ASSESSMENT QUESTIONNAIRE (CAT)
Applied at baseline and after 8 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kirsehir Ahi Evran Universitesi

Investigators

  • Principal Investigator: Yasemin CEYHAN, PhD, Kirsehir Ahi Evran Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Actual)

June 30, 2024

Study Completion (Estimated)

August 30, 2024

Study Registration Dates

First Submitted

February 22, 2024

First Submitted That Met QC Criteria

February 23, 2024

First Posted (Actual)

February 29, 2024

Study Record Updates

Last Update Posted (Actual)

August 7, 2024

Last Update Submitted That Met QC Criteria

August 6, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YCEYHANS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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