Chronic Obstructive Pulmonary DiseaseNCT04352829
VIDEO-TRAINING-SESSION ON METERED DOSE INHALER SKILLS AMONG INDIVIDUALS WITH COPD
A study testing VIDEO-TRAINING-SESSION ABOUT MDI USE in people with Chronic Obstructive Pulmonary Disease, run by Mersin University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 48 to 67 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- VIDEO-TRAINING-SESSION ABOUT MDI USE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Feb 2017to 1 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Batman Regional State Hospital
Batman, 72000
Mersin University
Mersin
About this study
Official title: THE EFFECT OF REPEATED VIDEO-TRAINING-SESSION ON METERED DOSE
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.
Read more
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- VIDEO-TRAINING-SESSION ABOUT MDI USE
- Keywords
- COPD, metered dose inhaler, training nursing, video session
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIDEO-TRAINING-SESSION ABOUT MDI USEOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
On the 2nd day, the patients were visited and were again asked to use the metered dose inhaler. While they were using the metered dose inhaler, the "Metered Dose Inhaler Skill Evaluation Form" was marked and "the scores of the 3rd measurement" were found. Later, a video session was held the same way as on the first day, the video was watched twice, and after each repetition the patients were requested to use the metered dose inhaler again. While they were using the metered dose inhaler, the skills and steps were simultaneously marked on the "Metered Dose Inhaler Skill Evaluation Form" and "the scores of the 4th measurement" were determined.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start1 Feb 2017
- Primary completion20 May 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- 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.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EBRU YILDIZ, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352829
- Sponsor's protocol ID
- VIDEO-TRAINING
- Status last verified
- Sep 2021
- First submitted
- 16 Apr 2020
- Last updated
- 16 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF REPEATED VIDEO-TRAINING-SESSION ON METERED DOSE
- ClinicalTrials.gov ID
- NCT04352829
- Acronym / sponsor ID
- VIDEO-TRAINING
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, metered dose inhaler, training nursing, video session
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 20 May 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 20 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| EXPERİMENTAL GROUP | Experimental | Other: VIDEO-TRAINING-SESSION ABOUT MDI USE1st 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. |
| 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. |
Who may qualify
- Ages
- 48 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIDEO-TRAINING-SESSION ABOUT MDI USEThe 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. | Other | EXPERİMENTAL GROUP |
Primary outcome
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
Time frame: 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.
1 secondary outcome
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
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIDEO-TRAINING-SESSION ABOUT MDI USE in people with Chronic Obstructive Pulmonary Disease, run by Mersin University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.