Clinical trial NCT04352829: VIDEO-TRAINING-SESSION ON METERED DOSE INHALER SKILLS AMONG INDIVIDUALS WITH COPD
Official title: THE EFFECT OF REPEATED VIDEO-TRAINING-SESSION ON METERED DOSE
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD, metered dose inhaler, training nursing, video session
Lead sponsor: Mersin University
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 40
Sex: ALL
Minimum age (years): 48
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: STUDY TYPE and STUDY AIM The study was experimentally undertaken in pre-test post-test control group design in order to assess the effect of video-training-session method upon adequacy of metered dose inhaler (MDI) among individuals with COPD.

STUDY POPULATION and SAMPLING In case of drop outs (wish to withdraw from the study, early hospital discharge, loss of life, etc), 20 patients were assigned to each group. The first 20 COPD patients who met the inclusion criteria were assigned to the control group whereas the second 20 COPD patients were assigned to the experimental group.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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
timeFrame: one day
Secondary outcomes:
measure: 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
timeFrame: one day
Other outcomes:
measure: 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 3rd day/final or 5th measurement
timeFrame: one day
Locations:
city: Batman
country: Turkey
facility: Batman Regional State Hospital
city: Mersin
country: Turkey
facility: Mersin University
Study officials:
References: