CopdNCT06286072
The Effect of Education and Reminder Messages on the Fatigue Level of Individuals With COPD
A study testing Education and message in people with Copd and Fatigue, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- What is being tested?
- Education and message
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with COPD for the last 1 year
- Hospitalized for at least 3 days,
- Voluntary patients
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Yasemin CEYHAN
Kırşehir, Center, 40100
Yasemin CEYHAN, PhD, +9054645898065, yasemin-ceyhan@hotmail.com
yasemin-ceyhan@hotmail.com
About this study
Official title: 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:
Read more
- Does the training given in COPD affect the level of fatigue?
- 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.
- Being tested
- Education and message
- Keywords
- COPD, Fatigue, dyspnea, Training, Message
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Fatigue, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and messageOther
COPD general education content and fatigue-specific coping strategies. Messages sent to phones
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Education and message |
| 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. Receives: Other: Education and message |
| 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. Receives: Other: Education and message |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Level
Evaluated with COPD ASTHMA FATIGUE SCALE.
Measured: Applied at baseline and after 8 weeks.
Dyspnea Severity
Evaluated with mMRC Dyspnea Scale
Measured: Applied at baseline and after 8 weeks.
Secondary outcomes (1)
COPD general condition
Evaluated with COPD ASSESSMENT QUESTIONNAIRE (CAT)
Measured: Applied at baseline and after 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start1 Nov 2023
- Primary completion30 Jun 2024
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin CEYHAN, Kirsehir Ahi Evran Universitesi
- Investigators
- Yasemin CEYHAN, PhD, Principal investigator, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286072
- Sponsor's protocol ID
- YCEYHANS
- Status last verified
- Aug 2024
- First submitted
- 22 Feb 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education and Reminder Messages on the Fatigue Level of Individuals With COPD: Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06286072
- Acronym / sponsor ID
- YCEYHANS
- Keywords
- COPD, Fatigue, dyspnea, Training, Message
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the training given in COPD affect the level of fatigue?
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Training and Message Group | Experimental | Other: Education and messagePatients 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 | Experimental | Other: Education and messagePatients 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 comparator | Other: Education and messageThese 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with COPD for the last 1 year
- Hospitalized for at least 3 days,
- Voluntary patients
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education and messageCOPD general education content and fatigue-specific coping strategies. Messages sent to phones | Other | Routine Treatment and Care Group, Training Group, Training and Message Group |
Primary outcome
Fatigue Level
Time frame: Applied at baseline and after 8 weeks.
Evaluated with COPD ASTHMA FATIGUE SCALE.
Dyspnea Severity
Time frame: Applied at baseline and after 8 weeks.
Evaluated with mMRC Dyspnea Scale
1 secondary outcome
COPD general condition
Time frame: Applied at baseline and after 8 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasemin CEYHAN, PhD principal investigator
Kirsehir Ahi Evran Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and message in people with Copd and Fatigue, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasemin CEYHAN (+905464589806, yasemin-ceyhan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Level (time frame: Applied at baseline and after 8 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.