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临床试验/NCT04260178
NCT04260178已完成不适用

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

Gönül GÖKÇAY4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年3月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
4
主要终点
Baseline Dyspnea Index(BDI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Baseline Dyspnea Index(BDI)

时间窗: 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.

pulmonary function test(PFT)

时间窗: 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.

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

时间窗: 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.

次要结局

  • body mass index(BMI)(Change from BMI at 3 months)

研究者

发起方
Gönül GÖKÇAY
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gönül GÖKÇAY

Lecturer

Kafkas University

研究点 (4)

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