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RecruitingNCT06286072Updated Aug 7, 2024

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

An interventional study of Education and message in Copd and Fatigue, sponsored by Kirsehir Ahi Evran Universitesi. Recruiting at 1 site in Turkey. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-08-07.

Sponsored by Kirsehir Ahi Evran Universitesi · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Nov 2023, registered Feb 2024).
  • Started Nov 2023; still recruiting 2 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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.
02

Conditions studied

  • Copd
  • Fatigue

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Keywords

  • COPD
  • Fatigue
  • dyspnea
  • Training
  • Message
03

In context

Fatigue

1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.

This study's planned enrollment of 120 is above the median of 54 across 1,440 interventional studies indexed under Fatigue.

Browse Fatigue studies →

Lead sponsor

Kirsehir Ahi Evran Universitesi is the lead sponsor of 133 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
120 participants (estimated)

Study arms

  • 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

  • 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

  • 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

Interventions

  • OtherEducation and message

    COPD general education content and fatigue-specific coping strategies. Messages sent to phones

06

What researchers measure

Primary outcomes

  1. Fatigue Level

    Evaluated with COPD ASTHMA FATIGUE SCALE.

    Time frame: Applied at baseline and after 8 weeks.

  2. Dyspnea Severity

    Evaluated with mMRC Dyspnea Scale

    Time frame: Applied at baseline and after 8 weeks.

Secondary outcomes

  1. COPD general condition

    Evaluated with COPD ASSESSMENT QUESTIONNAIRE (CAT)

    Time frame: Applied at baseline and after 8 weeks.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06286072
Lead sponsor
Kirsehir Ahi Evran Universitesi
Responsible party
Yasemin CEYHAN (Assistant Proffesor, Kirsehir Ahi Evran Universitesi) — Principal investigator
First posted
Feb 29, 2024
Start date
Nov 1, 2023
Primary completion
Jun 30, 2024
Completion
Aug 30, 2024 (estimated)
Last update
Aug 7, 2024

Study contacts

Yasemin CEYHAN
Contact
yasemin-ceyhan@hotmail.com
+905464589806
Yasemin CEYHAN, PhD
principal investigator · Kirsehir Ahi Evran Universitesi

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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