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临床试验/NCT04352829
NCT04352829已完成不适用

THE EFFECT OF REPEATED VIDEO-TRAINING-SESSION ON METERED DOSE

Mersin University3 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
3
主要终点
In order to determine the effect of repeated video-training-session method on the adequacy of metered dose inhaler in individuals with COPD, on the 1st day/scores of the 1st and 2nd measurements

研究概览

简要总结

OBJECTIVE: This study was undertaken to assess the effect of repeated video-training sessions on the adequacy of metered-dose inhaler (MDI) among individuals with COPD.

BACKGROUND: MDI devices facilitate the use of inhalation drugs in COPD patients and have become ever more important over the years. However, this device requires a certain level of hand-to- mouth coordination and cognitive ability. Since it has a high risk of application errors, training in its use is important to treatment success.

DESIGN: Randomised controlled trial METHOD: This study was carried out from 1 February to 1 July 2017 with the participation of 40 COPD patients. The data were collected using a 'Patient Information Request Form' and an 'MDI Skill Evaluation Form'. CONSORT checklist was used to report the current study. RESULTS: It was found that there was no significant difference between the experimental and control groups in terms of the mean scores of the 1st measurement (p > .05), though the mean scores of the 5th measurement were significantly higher in the experimental group (p< .001). In the 5th measurement, it was identified that the control group had 'moderate' adequacy (3.20±1.6), while the experimental group had 'satisfactory' adequacy (8.70 ± 1.17), indicating that the patients in the experimental group made fewer mistakes and showed improved adequacy.

CONCLUSION: It was found that repeated video-training sessions materially improved MDI skills. Relevance to clinical practice. Supporting the training on inhaler drug therapy with visual technological tools and regular checking of drug use will contribute to COPD management.

详细描述

Chronic Obstructive Pulmonary Disease (COPD) -one of the most important chronic health problems of respiratory system- is irreversible, progresses slowly and is characterized with chronic inflammation and airflow obstruction (1,2,3,4). According to the report of World Health Organization (WHO) "Non-communicable Diseases Progress Monitor 2017"; mortality rate in Turkiye due to non-communicable (chronic) diseases was 88% (78.271.000 population) (5), over the world, 65 million people lived with moderate to severe COPD and it is estimated that nearly 3 million people died of COPD in 2015 (5% of all deaths) (6). Besides; COPD -one of the respiratory system diseases- is ranked 4th among the causes of death over the world (7) and it is estimated that in 2020 it will be ranked 3rd (8).

Drug administration, an important nursing role, is a process that includes many disciplines. This process starts with patients' medical examination and physicians' prescription and includes phases of registration, observation of correct reactions and realization of the medical treatment by nurses, physicians, patient himself or his/her significant others (9). Training patients and families about treatment regime, observing patient's response to treatment and success of treatment are too among nurses' responsibilities (10).

According to the studies done in literature; the study of Choi and ChoChung (2001) explored a positive rise in adequacy of MDI among 101 asthma patients after the MDI training session given, the study of Press et al. (2012) was done with 80 COPD patients about adequacy of MDI and 82% of the participants performed steps of MDI use wrongly before the training while 25% of the participants performed the same steps wrongly after the training, the study of Işık et al. (2014) determined mistakes in using inhaler drugs and reported that patients were unable to receive effective and sufficient dose of drugs and the study Özkan and Kaşıkçı (2015) identified mistakes in using MDI and emphasized the usefulness of the training about MDI.

The study was planned to explore the steps where patients made mistakes while using MDI, to find out to what extent they used MDI correctly and to assess the effect of video-training-session upon adequacy of metered dose inhaler (MDI) among individuals with COPD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
48 Years 至 67 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Those who were voluntary to join the study, were ≥18 years old, had no hearing, vision and speaking impairment, no mental confusion, had full consciousness and orientation, had COPD diagnosis for ≥6 months and used MDI for more than 3 months were included in the study.

排除标准

  • Patients who did not volunteer to participate in the study, ≤18 years of age, hearing, vision and speech impairment, mental confusion, without full consciousness and orientation, diagnosed with COPD for less than 6 months and using MDI less than 3 months were not included in the study.

结局指标

主要结局

In order to determine the effect of repeated video-training-session method on the adequacy of metered dose inhaler in individuals with COPD, on the 1st day/scores of the 1st and 2nd measurements

时间窗: one day

On the 1st day, the 1st measurement was determined by filling out the "MDI Skill Evaluation Form" while the patients were using the MDI sample that did not contain active agent. Next, MDI use was explained through the video twice. After each video and explanation, the patients were asked to use the same MDI sample for 10 minutes. Simultaneously, steps were marked by the researcher through observation on the form, obtaining the scores of the 2nd measurement. The form including 10 adequacy steps about how to use an MDI. According to the scoring system, "0" point refers to a step being performed incorrectly or skipped, while "1" point refers to a correctly performed. The max. score that can be obtained is "10" and the min. score is "0". A total score of 7-10 was assessed as satisfactory, a score of 4-6 as moderate, and a score of 0-3 as unsatisfactory.

次要结局

  • In order to determine the effect of repeated video-training-session method on the adequacy of metered dose inhaler in individuals with COPD, on the 2nd day/scores of the 3rd and 4rd measurements(one day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

EBRU YILDIZ

lecturer

Mersin University

研究点 (3)

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