The Effect of Education and Reminder Messages on the Fatigue Level of Individuals With COPD
1 other identifier
interventional
120
1 country
1
Brief 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:
- Dyspnea severity,
- COPD general conditions and
- Fatigue level. The results obtained will be interpreted by comparing between 3 groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2023
CompletedFirst Submitted
Initial submission to the registry
February 22, 2024
CompletedFirst Posted
Study publicly available on registry
February 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2024
CompletedAugust 7, 2024
August 1, 2024
8 months
February 22, 2024
August 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Fatigue Level
Evaluated with COPD ASTHMA FATIGUE SCALE.
Applied at baseline and after 8 weeks.
Dyspnea Severity
Evaluated with mMRC Dyspnea Scale
Applied at baseline and after 8 weeks.
Secondary Outcomes (1)
COPD general condition
Applied at baseline and after 8 weeks.
Study Arms (3)
Training and Message Group
EXPERIMENTALPatients 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.
Training Group
EXPERIMENTALPatients 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.
Routine Treatment and Care Group
ACTIVE COMPARATORThese 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.
Interventions
COPD general education content and fatigue-specific coping strategies. Messages sent to phones
Eligibility Criteria
You may qualify if:
- Diagnosed with COPD for the last 1 year
- Hospitalized for at least 3 days,
- Voluntary patients
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yasemin CEYHAN
Kırşehir, Center, 40100, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yasemin CEYHAN, PhD
Kirsehir Ahi Evran Universitesi
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Proffesor
Study Record Dates
First Submitted
February 22, 2024
First Posted
February 29, 2024
Study Start
November 1, 2023
Primary Completion
June 30, 2024
Study Completion
August 30, 2024
Last Updated
August 7, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share