Education-Based İntervention Program for Persons With Chronic Obstructive Pulmonary Disease (EBIPCOPD)

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04260178
• Other study ID #: 80576354-050-99/37
• Status: Completed
• Phase: N/A
• Start date: March 4, 2019
• Est. completion date: June 27, 2019

Study information

• Verified date: October 2020
• Source: Kafkas University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 27, 2019
• Est. primary completion date: April 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• An Education-Based Intervention Program and handbook (EBIP, hospital and home)
A handbook was developed in line with the literature and input from two specialist physicians. The handbook consisted of 4 sections that concerned improving breathing exercises, drug compliance, nutrition and illness self-care behavior.
• PFT, BMI, BDI, SCMP-G
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

Locations

Country	Name	City	State
Turkey	Kafkas University-Ataturk Health Services Vocational School	Kars	Turkey/Kars
Turkey	Sakarya University Health Faculty of Health Sciences	Sakarya	Turke/Sakarya

Sponsors (1)

Lead Sponsor	Collaborator
Gönül GÖKÇAY

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Baker, E.,& Fatoye, F. (2018). PRS96-PATIENT PERCEIVED IMPACT OF NURSE-LED SELF-MANAGEMENT INTERVENTIONS FOR COPD: A SYSTEMATIC REVIEW OF QUALITATIVE RESEARCH. Value in Health, 21, S419-S420.

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pulmonary function test(PFT)	It is the COPD diagnostic criterion that the ratio of these two values is below 70% by measuring the forced vital capacity (FVC) with PFT and the demanding expiration volume (FEV1) in the first second and the ratio of these two values is calculated by FEV1 / FVC (% FEV1 predicted). According to the GOLD 2019 classification; 1. Stage-mild (FEV1=80% predicted), 2. Stage-moderate (50% =FEV1 <80% predicted), 3. Stage-severe (30% =FEV1 <50% predicted), 4. Stage-very severe ( FEV1 <30% predicted). In our study, the changes in FVC, FEV1, FEV1 / FVC (% FEV1) values were measured by including 2nd stage COPD patients.	Change from PFT at 3 months
Primary	Baseline Dyspnea Index(BDI)	The BDI score is based on ratings for three categories: functional impairment, size of task, and extent of effort. Dyspnea in each category is rated on a 5-point scale from 0 (severe) to 4 (intact). The scores of each category are added to create a total dyspnea score (between 0 and 12). Higher scores indicate worse dyspnea.	Change from BDI at 3 months
Primary	Self-Care Management Scale in Chronic Diseases(SCMP-G)	Scale with 35 questions; These two types of protection concepts, defined as self-protection (20 items) and social protection (15 items), constituted two sub-dimensions of the scale. Self-protection sub-dimension items 2, 6, 8, 11, 15, 18, 19, 20, 22, 23 and 25-34 and social-protection sub-dimension 1, 3-5, 7, 9, 10, 12-14, 16 Consists of 17, 21, 24 and 35 items. The assessment of the scale was developed from a 5-point Likert form as 5 (Strongly Agree) and 1 (Never Agree). Questions 3, 15, 19, and 28 on the SCMP-G scale are in the form of a negative question and the evaluation needs to be transformed. Self-care management increases as the score on the SCMP-G scale increases.The overall Cronbach alpha values of the scale are 0.75, 0.78 for the self-protection sub-dimension and 0.78 for the social-protection sub-dimension.	Change from SCMP-G at 3 months
Secondary	body mass index(BMI)	BMI was measured using weight and height data. Height was measured with a stadiometer (precision 1 cm) and weight was measured using a standard medical weighing scale (precision 1 kg). The interview was concluded for the control group at this point.	Change from BMI at 3 months

External Links

•   Global Initiative For Chronic Obstructive Lung Disease. Pocket Guide To Copd Diagnosis, Management, And Prevention.