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

NCT04260178 | Completed

• 1 other identifier: 80576354-050-99/37
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; dyspnea; self-care management; nurse education.

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• body mass index(BMI)

  Change from BMI at 3 months

Study Arms (2)

Experimental groups

EXPERIMENTAL

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.

Other: An Education-Based Intervention Program and handbook (EBIP, hospital and home); Other: PFT, BMI, BDI, SCMP-G

Control groups

OTHER

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.

Other: PFT, BMI, BDI, SCMP-G

Interventions

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

Experimental groups

PFT, BMI, BDI, SCMP-G 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; Experimental groups

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gönül GÖKÇAY: lead

Study Sites (2)

Sakarya University Health Faculty of Health Sciences

Sakarya, Turke/Sakarya, 2020, Turkey (Türkiye)

Location

Kafkas University-Ataturk Health Services Vocational School

Kars, Turkey/Kars, 36500, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 30130430 BACKGROUND

• 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.

  PMID: 30669076 RESULT

• 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.

  PMID: 18489687 RESULT

Related Links

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

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Interventions

Hospitals; Home Care Services; Body Mass Index

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Facilities; Health Care Facilities Workforce and Services; Community Health Services; Health Services; Nursing Services; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Anthropometry; Investigative Techniques; Physiological Phenomena; Biometry; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Ayşe ÇEVİRME

  Sakarya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: February 7, 2020
• Study Start: March 4, 2019
• Primary Completion: April 4, 2019
• Study Completion: June 27, 2019
• Last Updated: October 6, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)