Pulmonary Disease, Chronic ObstructiveNCT05730088
Reducing the Number of Hospital Admissions With Multiple Nursing Interventions in COPD Patients Using Oxygen Concentrators at Home
A study testing health education, Mobile application (Creating a WhatsApp group): and Telephone interview: in people with Pulmonary Disease, Chronic Obstructive, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
Chronic obstructive pulmonary disease (COPD) is a progressive lung disease characterized by persistent airflow obstruction and chronic respiratory symptoms or alpha-1-antitrypsin deficiency in response to inhaled cigarette smoke or other irritants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- health education, Mobile application (Creating a WhatsApp group): and Telephone interview:
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with stage 4 (group D) COPD according to GOLD criteria
- Being 18 years or older,
- Having a video computer, tablet or phone,
- Having an internet connection at home or on the phone,
- Residing in the city centre of Konya,
- Not having a communication problem, such as an inability to understand/speak Turkish, that would prevent participation in the research,
- Being literate,
- Using an oxygen concentrator at home.
Who cannot join
- Being illiterate,
- Being diagnosed with first, second and third-stage COPD according to GOLD criteria,
- Having another lung disease in addition to COPD (Lung cancer-Asthma, etc.),
- Having physical and/or mental disabilities,
- Being visually impaired and/or hearing impaired,
- Having a communication problem that prevents participation in the research, such as an inability to understand/speak Turkish,
- Having been diagnosed with Covid-19 or having had it in the past,
- Having a psychiatric disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Selçuk Tıp Fakültesi Hastanesi
Konya
About this study
Official title: The Effect of Post-Discharge Multiple Nursing Interventions on the Number of Hospital Admissions, Dyspnea Level, and Quality of Life in COPD Patients Receiving Home Oxygen Therapy: A Randomized Controlled Study
Chronic obstructive pulmonary disease (COPD) is a progressive lung disease characterized by persistent airflow obstruction and chronic respiratory symptoms or alpha-1-antitrypsin deficiency in response to inhaled cigarette smoke or other irritants. The excessive morbidity and mortality associated with COPD acute exacerbations represent a significant public health problem that places a high burden on patients, their families and society. In frequent and severe exacerbations, patients may experience a decrease in quality of life, depression, and even death up to one year after hospitalization. Costs associated with COPD are more than $15.5 billion, and hospitalizations and repeated hospital admissions related to acute exacerbations alone account for 70% of all costs. For these reasons, efforts to reduce hospital admissions and hospitalizations associated with recurrent exacerbations are imperative to improve patient's quality of life and reduce the societal burden.
Read the detailed description
The patients in the intervention group will be called by the researcher within 3-7 days after discharge for the purpose of getting to know each other. The researcher will inform the participants/relatives about the purpose of the study and the procedures to be performed. The date and time for the next call will be given and the next phone call will be planned. The researcher will inform the patients/relatives about the materials sent. During the phone call, any questions the patient has about their illness, medications, or oxygen concentrator will be answered by the researcher. Then, the patient will be asked whether they have been to the hospital after being discharged and this self-reported information will be recorded on the prepared hospital application form. If they have applied to the hospital, the department(s) will be asked and noted. At the end of the phone call, the time and day of the next call will be planned with the patient/relatives. The second phone call will be made by the researcher within 3 months after discharge to the patients in the intervention group and the date and time of the phone call will be planned after the approval of the researcher and the patient/relatives and the call plan will be made. During the phone call, the researcher will first introduce himself/herself and briefly explain why the phone call is being made. During the phone call, any questions the patient may have about his/her illness, medications, or oxygen concentrator will be answered by the researcher. Then, after the patient is discharged, the patient's hospital application will be asked and the answers received based on self-reporting will be written on the hospital application form. If there is a hospital application, the department/departments will be asked and noted. 5 minutes of the phone call will include introductions and general topics about the illness, the second 5 minutes will answer any questions the patient/relatives may have, and the last 5 minutes will end with the researcher providing consultancy services on what needs to be done in the future. Care will be taken not to exceed 20 minutes. At the end of the call, the date and time of the last call will be determined by talking to the patient/relative. In the phone call in the third month, the mMRC dyspnea scale and the St George Respiratory Questionnaire (Quality of Life Scale) and Hospital Application Form interim measurements will be collected by a researcher outside the study.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- health education, Mobile application (Creating a WhatsApp group):, Telephone interview:
- Keywords
- COPD, home visit, multiple nursing intervention, life quality
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health educationOther
Health Education: While they are still in the hospital, a 30-minute individually planned education about their disease will be given to patients using the COPD patient education booklet. step 1. Smoking cessation, step 2. Vaccination, step 3. Correct drug use, step 4. Regular exercise, step 5. Healthy eating, step 6. Coping with stress, step 7 Coping with attacks, step 8. Includes regular oxygen therapy. Let's learn nhaverug treatments in coping with COPD, under the title of pulmonary rehabilitation (Respiratory Rehabilitation), methods of coping with shortness of breath, indoor air pollution and outdoor air pollution subheadings.
Mobile application (Creating a WhatsApp group):Other
A group will be created through the WhatsApp application for participants in health education and visual and audio materials will be shared through this group every week. In the coming weeks, the researcher will provide consultancy services to those who have problems with the application.
Telephone interview:Other
Participants will be called every month by the researcher and asked if there are any hospital visits in that month, especially if they are chest disease visits.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Within the scope of the pre-test, the researcher to the patients who will explain the purpose of the research and agree to participate in the research; Inclusion Criteria Form; Socio-Demographic Information Form; Patient Descriptive Information Form, Modified British Medical Research Council (MRC) Questionnaire, St George Respiratory Questionnaire (Quality of Life Scale) will be used to evaluate patients' symptoms. In addition, the patients in the intervention group will be educated with the training booklet "Educational Guide for COPD Patients" prepared by the researcher by scanning the literature. Receives: Other: health education; Other: Mobile application (Creating a WhatsApp group):; Other: Telephone interview: |
| Not intervention group | No intervention | The control group will be subjected to the standard COPD training given in the hospital and no intervention will be made by the researcher. After the trials of the experimental group are completed, the control group will be given a home visit, a COPD training booklet, and audio-visual materials. |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of hospital admissions
Number of hospital admissions
Measured: At the end of the 1st month.
number of hospital admissions
Number of hospital admissions
Measured: At the end of the 3st month.
number of hospital admissions
Number of hospital admissions
Measured: At the end of the 6st month.
Secondary outcomes (6)
Scores from the mMRC Dyspnea scale (on the first encounter)
0 points for no dyspnea (no respiratory distress when moving quickly on a flat surface or climbing a gentle slope);
- point for mild dyspnea (difficulty breathing when moving quickly on a flat surface or climbing a gentle slope);
- points for moderate dyspnea (walks slower than peers when walking on level ground, pauses for breathing);
- points for severe dyspnea (stopping to breath after walking 100 meters or for a few minutes); and 4 points as very severe dyspnea (shortness of breath while doing daily chores at home, putting on/taking off clothes or going to the toilet).
As the score increases, the level of dyspnea also increases.
Measured: At the end of the 1st month.
Scores from the mMRC Dyspnea scale (on the first encounter)
0 points for no dyspnea (no respiratory distress when moving quickly on a flat surface or climbing a gentle slope);
- point for mild dyspnea (difficulty breathing when moving quickly on a flat surface or climbing a gentle slope);
- points for moderate dyspnea (walks slower than peers when walking on level ground, pauses for breathing);
- points for severe dyspnea (stopping to breath after walking 100 meters or for a few minutes); and 4 points as very severe dyspnea (shortness of breath while doing daily chores at home, putting on/taking off clothes or going to the toilet).
As the score increases, the level of dyspnea also increases.
Measured: At the end of the 3st month.
Scores from the mMRC Dyspnea scale (on the first encounter)
0 points for no dyspnea (no respiratory distress when moving quickly on a flat surface or climbing a gentle slope);
- point for mild dyspnea (difficulty breathing when moving quickly on a flat surface or climbing a gentle slope);
- points for moderate dyspnea (walks slower than peers when walking on level ground, pauses for breathing);
- points for severe dyspnea (stopping to breath after walking 100 meters or for a few minutes); and 4 points as very severe dyspnea (shortness of breath while doing daily chores at home, putting on/taking off clothes or going to the toilet).
As the score increases, the level of dyspnea also increases.
Measured: At the end of the 6st month.
Scores from the St George Respiratory Questionnaire
The total score that can be obtained from the scale is 0 min. - 100 max. The number zero indicates good health, and the number 100 indicates poor health. The scale is Likert type and the questions are in the form of "yes" and "no".
The symptoms section consists of 8 items and is scored in the range of 0-16 points.
The activity section consists of 16 items and is scored in the range of 0-32 points.
The effects of the disease section consists of 26 items and is scored in the range of 0-52 points.
Measured: At the end of the 1st month.
Scores from the St George Respiratory Questionnaire
The total score that can be obtained from the scale is 0 min. - 100 max. The number zero indicates good health, and the number 100 indicates poor health. The scale is Likert type and the questions are in the form of "yes" and "no".
The symptoms section consists of 8 items and is scored in the range of 0-16 points.
The activity section consists of 16 items and is scored in the range of 0-32 points.
The effects of the disease section consists of 26 items and is scored in the range of 0-52 points.
Measured: At the end of the 3st month.
Scores from the St George Respiratory Questionnaire
The total score that can be obtained from the scale is 0 min. - 100 max. The number zero indicates good health, and the number 100 indicates poor health. The scale is Likert type and the questions are in the form of "yes" and "no".
The symptoms section consists of 8 items and is scored in the range of 0-16 points.
The activity section consists of 16 items and is scored in the range of 0-32 points.
The effects of the disease section consists of 26 items and is scored in the range of 0-52 points.
Measured: At the end of the 6st month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start15 Feb 2023
- Primary completion15 Aug 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The Effect of Post-Discharge Multiple Nursing Interventions on the Number of Hospital Admissions, Dyspnea Level, and Quality of Life in COPD Patients Receiving Home Oxygen Therapy: A Randomized Controlled Study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Bakır, Necmettin Erbakan University
- Investigators
- DİLEK CİNGİL, Principal investigator, https://erbakan.edu.tr/hemsirelikfak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730088
- Sponsor's protocol ID
- NEU-HF-HBAKIR-01
- Status last verified
- Nov 2024
- First submitted
- 25 Jan 2023
- Last updated
- 22 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Post-Discharge Multiple Nursing Interventions on the Number of Hospital Admissions, Dyspnea Level, and Quality of Life in COPD Patients Receiving Home Oxygen Therapy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05730088
- Acronym / sponsor ID
- NEU-HF-HBAKIR-01
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- COPD, home visit, multiple nursing intervention, life quality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Feb 2023 (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.
Chronic obstructive pulmonary disease (COPD) is a progressive lung disease characterized by persistent airflow obstruction and chronic respiratory symptoms or alpha-1-antitrypsin deficiency in response to inhaled cigarette smoke or other irritants. The excessive morbidity and mortality associated with COPD acute exacerbations represent a significant public health problem that places a high burden on patients, their families and society. In frequent and severe exacerbations, patients may experience a decrease in quality of life, depression, and even death up to one year after hospitalization. Costs associated with COPD are more than $15.5 billion, and hospitalizations and repeated hospital admissions related to acute exacerbations alone account for 70% of all costs. For these reasons, efforts to reduce hospital admissions and hospitalizations associated with recurrent exacerbations are imperative to improve patient's quality of life and reduce the societal burden.
Detailed description
The patients in the intervention group will be called by the researcher within 3-7 days after discharge for the purpose of getting to know each other. The researcher will inform the participants/relatives about the purpose of the study and the procedures to be performed. The date and time for the next call will be given and the next phone call will be planned. The researcher will inform the patients/relatives about the materials sent. During the phone call, any questions the patient has about their illness, medications, or oxygen concentrator will be answered by the researcher. Then, the patient will be asked whether they have been to the hospital after being discharged and this self-reported information will be recorded on the prepared hospital application form. If they have applied to the hospital, the department(s) will be asked and noted. At the end of the phone call, the time and day of the next call will be planned with the patient/relatives. The second phone call will be made by the researcher within 3 months after discharge to the patients in the intervention group and the date and time of the phone call will be planned after the approval of the researcher and the patient/relatives and the call plan will be made. During the phone call, the researcher will first introduce himself/herself and briefly explain why the phone call is being made. During the phone call, any questions the patient may have about his/her illness, medications, or oxygen concentrator will be answered by the researcher. Then, after the patient is discharged, the patient's hospital application will be asked and the answers received based on self-reporting will be written on the hospital application form. If there is a hospital application, the department/departments will be asked and noted. 5 minutes of the phone call will include introductions and general topics about the illness, the second 5 minutes will answer any questions the patient/relatives may have, and the last 5 minutes will end with the researcher providing consultancy services on what needs to be done in the future. Care will be taken not to exceed 20 minutes. At the end of the call, the date and time of the last call will be determined by talking to the patient/relative. In the phone call in the third month, the mMRC dyspnea scale and the St George Respiratory Questionnaire (Quality of Life Scale) and Hospital Application Form interim measurements will be collected by a researcher outside the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The Effect of Post-Discharge Multiple Nursing Interventions on the Number of Hospital Admissions, Dyspnea Level, and Quality of Life in COPD Patients Receiving Home Oxygen Therapy: A Randomized Controlled Study
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: health education, Other: Mobile application (Creating a WhatsApp group):, Other: Telephone interview:Within the scope of the pre-test, the researcher to the patients who will explain the purpose of the research and agree to participate in the research; Inclusion Criteria Form; Socio-Demographic Information Form; Patient Descriptive Information Form, Modified British Medical Research Council (MRC) Questionnaire, St George Respiratory Questionnaire (Quality of Life Scale) will be used to evaluate patients' symptoms. In addition, the patients in the intervention group will be educated with the training booklet "Educational Guide for COPD Patients" prepared by the researcher by scanning the literature. |
| Not intervention group | No intervention | –The control group will be subjected to the standard COPD training given in the hospital and no intervention will be made by the researcher. After the trials of the experimental group are completed, the control group will be given a home visit, a COPD training booklet, and audio-visual materials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Being diagnosed with stage 4 (group D) COPD according to GOLD criteria
- Being 18 years or older,
- Having a video computer, tablet or phone,
- Having an internet connection at home or on the phone,
- Residing in the city centre of Konya,
Key exclusion criteria (8 listed)
- Being illiterate,
- Being diagnosed with first, second and third-stage COPD according to GOLD criteria,
- Having another lung disease in addition to COPD (Lung cancer-Asthma, etc.),
- Having physical and/or mental disabilities,
- Being visually impaired and/or hearing impaired,
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 |
|---|---|---|
| health educationHealth Education: While they are still in the hospital, a 30-minute individually planned education about their disease will be given to patients using the COPD patient education booklet. step 1. Smoking cessation, step 2. Vaccination, step 3. Correct drug use, step 4. Regular exercise, step 5. Healthy eating, step 6. Coping with stress, step 7 Coping with attacks, step 8. Includes regular oxygen therapy. Let's learn nhaverug treatments in coping with COPD, under the title of pulmonary rehabilitation (Respiratory Rehabilitation), methods of coping with shortness of breath, indoor air pollution and outdoor air pollution subheadings. | Other | intervention group |
| Mobile application (Creating a WhatsApp group):A group will be created through the WhatsApp application for participants in health education and visual and audio materials will be shared through this group every week. In the coming weeks, the researcher will provide consultancy services to those who have problems with the application. | Other | intervention group |
| Telephone interview:Participants will be called every month by the researcher and asked if there are any hospital visits in that month, especially if they are chest disease visits. | Other | intervention group |
Primary outcome
number of hospital admissions
Time frame: At the end of the 1st month.
Number of hospital admissions
number of hospital admissions
Time frame: At the end of the 3st month.
Number of hospital admissions
number of hospital admissions
Time frame: At the end of the 6st month.
Number of hospital admissions
6 secondary outcomes
Scores from the mMRC Dyspnea scale (on the first encounter)
Time frame: At the end of the 1st month.
Scores from the mMRC Dyspnea scale (on the first encounter)
Time frame: At the end of the 3st month.
Scores from the mMRC Dyspnea scale (on the first encounter)
Time frame: At the end of the 6st month.
Scores from the St George Respiratory Questionnaire
Time frame: At the end of the 1st month.
Scores from the St George Respiratory Questionnaire
Time frame: At the end of the 3st month.
Scores from the St George Respiratory Questionnaire
Time frame: At the end of the 6st month.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
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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.
DİLEK CİNGİL principal investigator
https://erbakan.edu.tr/hemsirelikfak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing health education, Mobile application (Creating a WhatsApp group): and Telephone interview: in people with Pulmonary Disease, Chronic Obstructive, run by Necmettin Erbakan University 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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 22 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HASAN BAKIR (05055346870, smhasanbakir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of hospital admissions (time frame: At the end of the 1st month.). The study lists 3 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 22 Nov 2024.