Clinical trial NCT04260178: Education-Based İntervention Program for Persons With Chronic Obstructive Pulmonary Disease (EBIPCOPD)
Official title: The Impact Of An Education-Based Intervention Program (EBIP) On Dyspnea And Chronic Self-Care Management Among Copd Patients: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
dyspnea
self-care management
nurse education.
Lead sponsor: Kafkas University
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: OTHER

Brief summary: Obstructive Pulmonary Disease(COPD) treatment, leading to the role of nurses to become more and more important. An Education-Based Intervention Program(EBIP) consists of several steps that aim to achieve better health outcomes through guidingCOPD patients to reduce dyspnea symptoms and improve chronic self-care management skills. The aim of this study is to evaluate the dyspnea and chronic self-care management outcomes of EBIP compared to routine care.

Research Hypotheses:

H0: EBIP has no effect on dyspnea or chronic self-care management in COPD patients.

H1: EBIP effects dyspnea outcomes of COPD patients. H2: EBIP effects chronic self-care management outcomes of COPD patients.

Detailed description: Abstract:

Background:Non-pharmacological interventions are a valuable aspect of Chronic Obstructive Pulmonary Disease(COPD) treatment, leading to the role of nurses to become more and more important. An Education-Based Intervention Program(EBIP) consists of several steps that aim to achieve better health outcomes through guidingCOPD patients to reduce dyspnea symptoms and improve chronic self-care management skills. The aim of this study is to evaluate the dyspnea and chronic self-care management outcomes of EBIP compared to routine care.

Method:A total of 61 Stage II COPD patients that were hospitalized and treated in the month of January 2019 in a university hospital were selected for the study, who had been discharged less than one month ago and resided downtown. 51 conforming patients were divided into experimental(EBIP intervention) and control groups for a single-blind randomized trial. Data were collected using an introductory information form, pulmonary function test(PFT), the Baseline Dyspnea Index(BDI), body mass index(BMI) and the Self Care Management Process in Chronic Illness(SCMP-G) scale. There were no addition interventions to the control group. The intervention group underwent a 3-month EBIP intervention that included education, house visits and follow-ups through phone calls. The data were analyzed using SPSS version 17.0 with descriptive statistics, x2,Mann Whitney U and Wilcoxon signed-rank tests. p\<0.05 was statistically significant.

Eligibility criteria: Inclusion Criteria:

* Individuals to be included in the study are 18 years of age and over
* have been diagnosed with COPD Stage 2 for six months or more,
* not having been in hospital for one month after discharge, - no communication problems,
* lack of mental confusion,
* conscious and complete orientation
* volunteering to participate in the research,
* It is planned to be conducted with patients living in the center of Kars.

Exclusion Criteria:

* Being 18 years old and under,
* KOAH stage 1, 2, 4 diagnosed,
* being a communication problem,
* having mental confusion or
* having any psychiatric problem,
* not volunteering to participate in the research,
* Living outside the Kars center

Primary outcomes:
measure: pulmonary function test(PFT)
timeFrame: Change from PFT at 3 months
measure: Baseline Dyspnea Index(BDI)
timeFrame: Change from BDI at 3 months
measure: Self-Care Management Scale in Chronic Diseases(SCMP-G)
timeFrame: Change from SCMP-G at 3 months
Secondary outcomes:
measure: body mass index(BMI)
timeFrame: Change from BMI at 3 months
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sakarya University Health Faculty of Health Sciences
state: Turke/Sakarya
city: Kars
country: Turkey
facility: Kafkas University-Ataturk Health Services Vocational School
state: Turkey/Kars
Study officials:
affiliation: Sakarya University
name: Ayşe ÇEVİRME
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thom DH, Willard-Grace R, Tsao S, Hessler D, Huang B, DeVore D, Chirinos C, Wolf J, Donesky D, Garvey C, Su G. Randomized Controlled Trial of Health Coaching for Vulnerable Patients with Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2018 Oct;15(10):1159-1168. doi: 10.1513/AnnalsATS.201806-365OC.
citation: Baker E, Fatoye F. Patient perceived impact of nurse-led self-management interventions for COPD: A systematic review of qualitative research. Int J Nurs Stud. 2019 Mar;91:22-34. doi: 10.1016/j.ijnurstu.2018.12.004. Epub 2018 Dec 31.
citation: Efraimsson EO, Hillervik C, Ehrenberg A. Effects of COPD self-care management education at a nurse-led primary health care clinic. Scand J Caring Sci. 2008 Jun;22(2):178-85. doi: 10.1111/j.1471-6712.2007.00510.x.