VIDEO-TRAINING-SESSION ON METERED DOSE INHALER SKILLS AMONG INDIVIDUALS WITH COPD

NCT04352829 | Completed

• 1 other identifier: VIDEO-TRAINING
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, metered dose inhaler, training nursing, video session

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  one day

Secondary Outcomes (1)

• 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

Other Outcomes (1)

• 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

  one day

Study Arms (2)

EXPERİMENTAL GROUP

EXPERIMENTAL

1st day, patients were asked to use an MDI sample that didn't contain an active agent. At the same time, they filled the MDI Skill Evaluation Form, obtaining 'the scores of the 1st measurement'. 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 min. Simultaneously, the skills were marked by the researcher through observation on the form, obtaining 'the scores of the 2nd measurement'. 2nd day, they were again asked to use the MDI. While using the MDI, the form was marked and 'the scores of the 3rd measurement' were found. Later, a video session was held as on the 1st day, the video was watched twice, and after each repetition, were requested to use the MDI again. While they were using the MDI, the skills were simultaneously marked on the form and 'the scores of the 4th measurement were determined. 3rd day, all steps were repeated.

Other: VIDEO-TRAINING-SESSION ABOUT MDI USE

CONTROL GROUP

NO INTERVENTION

20 patients were recruited to the control group. The controls received a routine training on MDI from their clinic nurses including verbal explanation of MDI use. The controls received training about MDI use in line with ethical principles and watched the video once after the 5th measurement. After the study, participants who wished to watch the training video again were provided internet links.

Interventions

VIDEO-TRAINING-SESSION ABOUT MDI USE OTHER

The steps were demonstrated with the brochure that illustrated correct inhalation techniques and were prepared by Turkish Respiratory Research Society-Inhalation Treatment Study Group in line with the literature and were described with a video that was designed by Turkish National Society of Allergy and Clinical Immunology (25). The video is provided with a free access on the webpage of Turkish National Society of Allergy and Clinical Immunology.The video included images that explained the steps about what to do before MDI use, how to use the device and the issues to which attention should be paid during the use of the device and focused on the skill-steps that should gradually be performed about MDI use.

EXPERİMENTAL GROUP

Eligibility Criteria

• Age: 48 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mersin University: lead

Study Sites (2)

Batman Regional State Hospital

Batman, 72000, Turkey (Türkiye)

Location

Mersin University

Mersin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: 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.

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 20, 2020
• Study Start: February 1, 2017
• Primary Completion: May 20, 2017
• Study Completion: July 1, 2017
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)