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

NCT ID: NCT04260178

Last Updated: 2020-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-04

Study Completion Date

2019-06-27

Brief Summary

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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

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled trial
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
Double blinding is not considered possible for EBIP interventions, where participants and researcher can recognize group assignment. However, giving and scoring the assessments were masked wherever feasible. The assistant researcher who administered and scored the questionnaires and the nurse that carried out PFT measurement and assessments were blind to experimental groups. Coded answer sheets were analyzed only after the study's completion

Study Groups

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Experimental groups

For the experimental group, EBIP was implemented in three stages:(1) hospital training;(2) home visits + training, which includes motivational interventions that facilitate chronic disease self-care and symptom management with nurse-patient cooperation; and (3) telephone follow-ups and assistance. A handbook was developed in line with the relevant literature and input from two specialist physicians (1,17-20). The handbook consisted of 4 sections that concerned improving breathing exercises, drug compliance, nutrition and illness self-care behavior. The trainings sessions were conducted in a hospital seminar room using PowerPoint presentations. Afterward, patients were asked to demonstrate what they learned, and the parts that were not clear were explained again. The training was concluded after deciding for the first home visit appointment. For patients that could not effectively use the handbook, a close relative was included to all steps of the study.

Group Type EXPERIMENTAL

An Education-Based Intervention Program and handbook (EBIP, hospital and home)

Intervention Type OTHER

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

Intervention Type OTHER

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

Control groups

Control groups were evaluated with an introductory survey form, PFT, BDI, BMI and SCMP-G scales before and after the study. There were no additional interventions to the control group.

Group Type OTHER

PFT, BMI, BDI, SCMP-G

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gönül GÖKÇAY

OTHER

Sponsor Role lead

Responsible Party

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Gönül GÖKÇAY

Lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ayşe ÇEVİRME

Role: PRINCIPAL_INVESTIGATOR

Sakarya University

Locations

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Sakarya University Health Faculty of Health Sciences

Sakarya, Turke/Sakarya, Turkey (Türkiye)

Site Status

Kafkas University-Ataturk Health Services Vocational School

Kars, Turkey/Kars, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 30130430 (View on PubMed)

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.

Reference Type RESULT
PMID: 30669076 (View on PubMed)

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.

Reference Type RESULT
PMID: 18489687 (View on PubMed)

Related Links

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https://goldcopd.org/wp-content/uploads/2018/11/GOLD-2019-POCKET-GUIDE-FINAL_WMS.pdf

Global Inıtıatıve For Chronıc Obstructıve Lung Dısease. Pocket Guıde To Copd Dıagnosıs, Management, And Preventıon.

Other Identifiers

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80576354-050-99/37

Identifier Type: -

Identifier Source: org_study_id

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