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Completed

NCT Number: NCT04260178

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sakarya University Health Faculty of Health Sciences, Sakarya, Turke/Sakarya, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

  1. pulmonary function test(PFT)

    Time frame: Change from PFT at 3 months

    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.

  2. Baseline Dyspnea Index(BDI)

    Time frame: Change from BDI at 3 months

    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.

  3. Self-Care Management Scale in Chronic Diseases(SCMP-G)

    Time frame: Change from SCMP-G at 3 months

    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 outcomes

  1. body mass index(BMI)

    Time frame: Change from BMI at 3 months

    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.

Sponsors and collaborators

Lead sponsor

Gönül GÖKÇAY

Other

Registry information

Official study title

The Impact Of An Education-Based Intervention Program (EBIP) On Dyspnea And Chronic Self-Care Management Among Copd Patients: A Randomized Controlled Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 7, 2020
Registry last updated
Oct 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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