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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
An Education-Based Intervention Program and handbook (EBIP, hospital and home)
PFT, BMI, BDI, SCMP-G
Sponsored by
Gönül GÖKÇAY
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, dyspnea, self-care management, nurse education.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sakarya University Health Faculty of Health Sciences
  • Kafkas University-Ataturk Health Services Vocational School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental groups

Control groups

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 24, 2020
Last Updated
October 2, 2020
Sponsor
Gönül GÖKÇAY
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1. Study Identification

Unique Protocol Identification Number
NCT04260178
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 4, 2019 (Actual)
Primary Completion Date
April 4, 2019 (Actual)
Study Completion Date
June 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gönül GÖKÇAY

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, dyspnea, self-care management, nurse education.

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
Outcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental groups
Arm Type
Experimental
Arm Description
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.
Arm Title
Control groups
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
An Education-Based Intervention Program and handbook (EBIP, hospital and home)
Intervention Description
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
Intervention Name(s)
PFT, BMI, BDI, SCMP-G
Intervention Description
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
Primary Outcome Measure Information:
Title
pulmonary function test(PFT)
Description
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.
Time Frame
Change from PFT at 3 months
Title
Baseline Dyspnea Index(BDI)
Description
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.
Time Frame
Change from BDI at 3 months
Title
Self-Care Management Scale in Chronic Diseases(SCMP-G)
Description
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.
Time Frame
Change from SCMP-G at 3 months
Secondary Outcome Measure Information:
Title
body mass index(BMI)
Description
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.
Time Frame
Change from BMI at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayşe ÇEVİRME
Organizational Affiliation
Sakarya University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sakarya University Health Faculty of Health Sciences
City
Sakarya
State/Province
Turke/Sakarya
ZIP/Postal Code
2020
Country
Turkey
Facility Name
Kafkas University-Ataturk Health Services Vocational School
City
Kars
State/Province
Turkey/Kars
ZIP/Postal Code
36500
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30130430
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.
Results Reference
background
PubMed Identifier
30669076
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.
Results Reference
result
PubMed Identifier
18489687
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.
Results Reference
result
Links:
URL
https://goldcopd.org/wp-content/uploads/2018/11/GOLD-2019-POCKET-GUIDE-FINAL_WMS.pdf
Description
Global Inıtıatıve For Chronıc Obstructıve Lung Dısease. Pocket Guıde To Copd Dıagnosıs, Management, And Preventıon.

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

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