Clinical trial NCT05730088: Reducing the Number of Hospital Admissions With Multiple Nursing Interventions in COPD Patients Using Oxygen Concentrators at Home
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD
home visit
multiple nursing intervention
life quality
Lead sponsor: Necmettin Erbakan University
Sponsor class: OTHER
First posted: 2023-02-15
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: number of hospital admissions
timeFrame: At the end of the 1st month.
measure: number of hospital admissions
timeFrame: At the end of the 3st month.
measure: number of hospital admissions
timeFrame: At the end of the 6st month.
Secondary outcomes:
measure: Scores from the mMRC Dyspnea scale (on the first encounter)
timeFrame: At the end of the 1st month.
measure: Scores from the mMRC Dyspnea scale (on the first encounter)
timeFrame: At the end of the 3st month.
measure: Scores from the mMRC Dyspnea scale (on the first encounter)
timeFrame: At the end of the 6st month.
measure: Scores from the St George Respiratory Questionnaire
timeFrame: At the end of the 1st month.
measure: Scores from the St George Respiratory Questionnaire
timeFrame: At the end of the 3st month.
measure: Scores from the St George Respiratory Questionnaire
timeFrame: At the end of the 6st month.
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selçuk Tıp Fakültesi Hastanesi
Study officials:
affiliation: https://erbakan.edu.tr/hemsirelikfak
name: DİLEK CİNGİL
role: PRINCIPAL_INVESTIGATOR
References: