Reducing the Number of Hospital Admissions With Multiple Nursing Interventions in COPD Patients Using Oxygen Concentrators at Home

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05730088
• Other study ID #: NEU-HF-HBAKIR-01
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: April 2024
• Source: Necmettin Erbakan University
• Contact: HASAN BAKIR
• Phone: 05055346870
• Email: smhasanbakir[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Description:

Among the multiple nursing interventions that are thought to be effective in reducing COPD-related readmissions and hospital admissions, post-discharge patient education, home visits, telephone calls, and the use of mobile health applications seem to increase the quality of life of their patients. However, it is revealed in the literature that situations involving multiple home visits and follow-up phone calls, which are among multiple nursing interventions, have a great effect on reducing re-hospital admissions.In addition, it has been proven that smart technologies, which are frequently used in today's technology age, are effective in supporting, promoting and maintaining individualized care among people with COPD and other chronic diseases, and are very effective in reducing the cost of care.In studies involving multiple nursing interventions, it is seen that face-to-face training meetings, home visits, and effective use of information and communication technology facilitate individualized care and support the potential of behaviour change and chronic conditions. These initiatives appear to facilitate behaviour change by providing motivational training programs and other online resource materials that are ubiquitously accessible and often low-cost in our time. Being in close contact with patients after discharge and following the course of the disease play a vital role in supporting the health and safety of patients after they leave the hospital. This close interaction helps patients avoid the negativities of the disease, get the medical treatment and care they need, and detect worrisome signs and symptoms before they become unmanageable. One of the multiple nursing interventions is patient education. In some studies on patient education, some training was given face-to-face, and some training was given via telephone interviews. These studies show that nurse-led health education can be safely integrated into clinical practice for patients with COPD. Another multiple nursing intervention is home visits. Home visits are very important in terms of closely observing the practices of the patient in the environment where he/she lives. One study showed that patients who received two or more home visits had fewer repeated hospital visits. Considering the rates of repeated hospital admissions, it was seen that the rate of hospital admissions of patients who received 2 or more home visits after discharge was 24%, while the rate of repeated hospital admissions of patients who did not receive home visits was 36%. In studies evaluating the use of remote technology, which is frequently used in multiple nursing interventions, it is seen that information and communication technology facilitates behaviour change and self-management of chronic conditions and increases its support potential. Mobile applications in information communication technology seem to facilitate behaviour change by providing motivational training programs and other online resource materials that are always accessible and generally low-cost in our age. As a method of enabling sustainable behaviour change and self-management, mobile apps can minimize hospital readmissions and provide a better quality of life for patients with COPD.

Method: This study is a randomized controlled experimental study with a pretest-posttest control group to examine the effect of multiple nursing interventions on the number of hospital admissions, dyspnea level and quality of life at the end of six months in COPD patients receiving home oxygen therapy. The research will be carried out between 01 February

• 01 August 2023, Selcuk University Selcuk Medical Faculty Hospital Chest Diseases.With the G-power program, the sample size was found to be with an effect size of 0.83, a confidence level of 95%, and a power of 90% with a total of 64 individuals, 32 of which were in the intervention group and 32 in the control group.In the study, 10% dropout rate and 5% mortality rate were estimated and a 15% loss model was taken and the sample number was decided to be 74.

Management: In the first interview to be held within the scope of the pre-test with the patients to be included in the intervention group; Inclusion Criteria Form; Sociodemographic Information Form; Patients in the intervention group will have to fill out the Patient Descriptive Information Form, the Modified British Medical Research Council (mMRC) Questionnaire to assess patients' symptoms, and the St George Respiratory Questionnaire (Quality of Life Scale). In addition, the patients in the intervention group will be educated with the "Educational Guide for COPD Patients", the training booklet prepared by the researcher by scanning the literature.

Application:

• Factsheet, mMRC Dyspnea Scale, and St George Respiratory Questionnaire Scale pretests will be administered to COPD patients who agree to participate in the study and meet inclusion criteria, with informed consent. Patients who agree to participate will be assigned to the experimental or control group according to a stratified randomization list previously prepared by an independent statistician.

• Deep breathing exercises, oxygen concentrator use, and inhaler drug use training will be given to each participant for a limited time of 30 minutes through the "Training Guide for COPD Patients" prepared by the researcher, before being discharged from the hospital after the pre-test is done for the patients in the intervention group.

• Later, a group will be created for the intervention group via the WhatsApp program and the patients in the intervention group will be added. Participants in the intervention group of this program will be informed and the purpose of this group will be explained. The researcher will be the manager of the WhatsApp group and will share weekly visual and audio materials about COPD. Answers will be given to questions from patients on WhatsApp. Viewing the submitted materials will be requested from the participants by the researcher. Patients in the intervention group will be told that they can ask any questions about their illness the researcher. What is COPD in the first week, risk factors in COPD in the second week, diagnostic methods in COPD in the third week, how to protect against COPD in the fourth week, drug therapy in COPD in the fifth week, nutrition in COPD in the sixth week, respectively? Visual and audio materials will be shared about the subjects of lifestyle and lifestyle, inhaler device use in COPD in the seventh week, and pulmonary rehabilitation in the eighth week.

• A visit plan will be made by informing the patients/relatives that home visits will be made by the researcher within 3-7 days after discharge for the patients in the intervention group and that the date and time of the visit will be arranged after the researcher and patient/relatives approve.

Before going to the home visit, the patient/patient's relative will be called by phone and it will be confirmed whether they are at home and the visiting time will be determined. During the home visit, the researcher will first introduce himself and briefly explain why the home visit was made. During the home visit, if the patient has questions about his illness, the drugs he uses, and the oxygen concentrator, they will be answered by the researcher. Then, the patient will be asked whether he went to the hospital after discharge. If he went to the hospital, he will be asked which department(s) and it will be noted. The first 15 minutes of the home visit will include general topics related to an acquaintance and the disease, the second 15 minutes will be answered by the patient/patient relatives if any, and the last 15 minutes will be completed by the researcher providing consultancy services on what to do in the next period.

• The home visit will not exceed 45 minutes. When leaving last, the next visit time and day will be determined by planning with the patient/patient relatives. A visit plan will be made by informing the patients in the intervention group that the second home visit will be made by the researcher within the 3rd month after discharge and that the date and time of the visit will be arranged after the approval of the researcher and the patient/patient relatives. Before going to the home visit, the patient/patient's relative will be called by phone and it will be confirmed whether they are at home and the visiting time will be determined. During the home visit, the researcher will first introduce himself and briefly explain why the home visit was made. During the home visit, if the patient has questions about his illness, the drugs he uses, and the oxygen concentrator, they will be answered by the researcher. Then, the patient will be asked whether he went to the hospital after discharge. If he went to the hospital, he will be asked which department(s) and it will be noted. The first 15 minutes of the home visit will include general topics related to an acquaintance and the disease, the second 15 minutes will be answered by the patient/patient relatives if any, and the last 15 minutes will be completed by the researcher providing consultancy services on what to do in the next period. The home visit will not exceed 45 minutes. When leaving last, the date and time of the last home visit will be determined by talking to the patient/relative. At the third month home visit, the mMRC dyspnea scale and St George's Respiratory Questionnaire (Quality of Life Scale) will be filled again and an interim measurement will be taken.

• Once a month, patients in the intervention group will be asked whether they have applied to health institutions such as polyclinic/emergency/health cabin, via WhatsApp and by phone. The researcher will provide a counselling service that will answer all the questions of the patients for six months. After the first interview, at the end of the sixth month, the post-test data will be collected at the patients' homes and by a foreign researcher or interviewer. The intervention table for the intervention group is shown below.

Control group 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: June 1, 2024
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• health education
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):
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.
• Home visit:
Participants will be visited at home three times. During the home visit, any questions about their illness and the oxygen concentrator they use will be answered. During the home visits, the researcher will provide consultancy services.
• 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.

Locations

Country	Name	City	State
Turkey	Selçuk Tip Fakültesi Hastanesi	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Necmettin Erbakan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of hospital admissions	Number of hospital admissions	At the end of the 1st month.
Primary	number of hospital admissions	Number of hospital admissions	At the end of the 3st month.
Primary	number of hospital admissions	Number of hospital admissions	At the end of the 6st month.
Secondary	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.	At the end of the 1st month.
Secondary	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.	At the end of the 3st month.
Secondary	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.	At the end of the 6st month.
Secondary	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.	At the end of the 1st month.
Secondary	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.	At the end of the 3st month.
Secondary	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.	At the end of the 6st month.