COPDNCT04052906
The Effect On Self-Care and Self-Efficacy of Inhaler Training in COPD
A study testing Training in people with COPD, run by Nevsehir Haci Bektas Veli University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effect of planned inhaler medication training on self-care agency and self-efficacy level. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- COPD
- What is being tested?
- Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2017to 1 May 2018
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are literate,
- Diagnosed with COPD at least six months ago,
- Using inhaler medication since three or more months,
- Moderate or severe COPD, according to GOLD criteria,
- Incorrect use inhaler medication uses according to the list of inhaler medication use skills,
- No communication problems,
- No mental confusion or any psychiatric problem,
- Agrees to participate in the study.
Who cannot join
- Cognitive dysfunction,
- Severe pulmonary, cardiological or malignant disease,
- In a period of exacerbation,
- Correctly performs all steps for their prescribed inhaler medication(s), according to the list of inhaler skills.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the effect of planned inhaler medication training on self-care agency and self-efficacy level.
Read the detailed description
Pulmonary diseases are a major source of mortality and morbidity globally. The major symptom of COPD is dyspnea. Since dyspnea leads to activity limitation and inadequate self-care skills among individuals, it is often associated with major psychological comorbidity, social isolation and poor perceived quality of life. COPD patients with high self-efficacy are high enough to level of treatment adherence. On the other hand, the most preferred treatment method for the management and mitigation of COPD symptoms is by the use of inhaler medication. However, incorrect use of the inhaler would lead to failure in the control of COPD patients. Also, it fails to provide COPD patients with self-care agency and self-efficacy levels. In COPD, planned inhaler medication training has been shown in many studies to reduce dyspnoea, increase self-care and self-efficacy levels. Therefore, planned inhaler medication training increases quality of life in COPD patients.
- Conditions
- COPD
- Being tested
- Training
- Keywords
- COPD, dyspnea, self-efficacy, self-care
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
Planned Inhaler Medication Trainning
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Planned Inhaler Medication Training Receives: Other: Training |
| Control Group | No intervention | usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD Self-Efficacy Scale (CSES)
CSES developed by Wigal et al. (1991) is used to determine the degree of confidence that COPD patients have in managing or avoiding breathing difficulty during certain activities. The scale consists of 34 items and 5 subscales.
Measured: baseline to the 3 months after intervention
Self-Care Agency Scale
The Self-care Agency Scale (1979) was developed by Kearney and Fleischer, and its validity and reliability study in Turkey was conducted by Nahcivan in 1993. With this scale consisting of 35 items, patients evaluate their ability or agency to perform self-care actions.
Measured: baseline to the 3 months after intervention
Secondary outcomes (2)
Modified Borg Dyspnea Scale
While the Modified Borg Scale is nowadays generally used to define the severity of dyspnea in exercise, it can also be used to assess the severity of resting dyspnea
Measured: baseline to the 3 months after intervention
Medical Research Council (MRC) Dyspnea Scale
The dyspnea scale is a 1 to 5 score scale consisting of five items based on various physical activities that produce a feeling of dyspnea.
Measured: baseline to the 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start1 Nov 2017
- Primary completion1 Feb 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nevsehir Haci Bektas Veli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze MUZ, Nevsehir Haci Bektas Veli University
- Investigators
- Gamze Muz, PhD, Study chair, Nevsehir Haci Bektas Veli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052906
- Sponsor's protocol ID
- NevsehirHBVU
- Status last verified
- Nov 2019
- First submitted
- 7 Aug 2019
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kearney BY, Fleischer BJ. Development of an instrument to measure exercise of self-care agency. Res Nurs Health. 1979 Mar;2(1):25-34. doi: 10.1002/nur.4770020105. No abstract available.
PubMed 254279Wigal JK, Creer TL, Kotses H. The COPD Self-Efficacy Scale. Chest. 1991 May;99(5):1193-6. doi: 10.1378/chest.99.5.1193.
PubMed 2019177Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
PubMed 7154893Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999 Jul;54(7):581-6. doi: 10.1136/thx.54.7.581.
PubMed 10377201FLETCHER CM. The clinical diagnosis of pulmonary emphysema; an experimental study. Proc R Soc Med. 1952 Sep;45(9):577-84. No abstract available.
PubMed 13003946Goris S, Tasci S, Elmali F. The effects of training on inhaler technique and quality of life in patients with COPD. J Aerosol Med Pulm Drug Deliv. 2013 Dec;26(6):336-44. doi: 10.1089/jamp.2012.1017. Epub 2013 Feb 19.
PubMed 23421900
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect On Self-Care and Self-Efficacy of Inhaler Training in COPD
- ClinicalTrials.gov ID
- NCT04052906
- Acronym / sponsor ID
- NevsehirHBVU
- Conditions
- COPD
- Keywords
- COPD, dyspnea, self-efficacy, self-care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Nevsehir Haci Bektas Veli UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 12 Aug 2019 (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.
This study aims to evaluate the effect of planned inhaler medication training on self-care agency and self-efficacy level.
Detailed description
Pulmonary diseases are a major source of mortality and morbidity globally. The major symptom of COPD is dyspnea. Since dyspnea leads to activity limitation and inadequate self-care skills among individuals, it is often associated with major psychological comorbidity, social isolation and poor perceived quality of life. COPD patients with high self-efficacy are high enough to level of treatment adherence. On the other hand, the most preferred treatment method for the management and mitigation of COPD symptoms is by the use of inhaler medication. However, incorrect use of the inhaler would lead to failure in the control of COPD patients. Also, it fails to provide COPD patients with self-care agency and self-efficacy levels. In COPD, planned inhaler medication training has been shown in many studies to reduce dyspnoea, increase self-care and self-efficacy levels. Therefore, planned inhaler medication training increases quality of life in COPD patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: TrainingPlanned Inhaler Medication Training |
| Control Group | No intervention | –usual care |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects who are literate,
- Diagnosed with COPD at least six months ago,
- Using inhaler medication since three or more months,
- Moderate or severe COPD, according to GOLD criteria,
- Incorrect use inhaler medication uses according to the list of inhaler medication use skills,
Key exclusion criteria (4 listed)
- Cognitive dysfunction,
- Severe pulmonary, cardiological or malignant disease,
- In a period of exacerbation,
- Correctly performs all steps for their prescribed inhaler medication(s), according to the list of inhaler skills.
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 |
|---|---|---|
| TrainingPlanned Inhaler Medication Trainning | Other | Intervention Group |
Primary outcome
COPD Self-Efficacy Scale (CSES)
Time frame: baseline to the 3 months after intervention
CSES developed by Wigal et al. (1991) is used to determine the degree of confidence that COPD patients have in managing or avoiding breathing difficulty during certain activities. The scale consists of 34 items and 5 subscales.
Self-Care Agency Scale
Time frame: baseline to the 3 months after intervention
The Self-care Agency Scale (1979) was developed by Kearney and Fleischer, and its validity and reliability study in Turkey was conducted by Nahcivan in 1993. With this scale consisting of 35 items, patients evaluate their ability or agency to perform self-care actions.
2 secondary outcomes
Modified Borg Dyspnea Scale
Time frame: baseline to the 3 months after intervention
Medical Research Council (MRC) Dyspnea Scale
Time frame: baseline to the 3 months after intervention
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 6 Nov 2019.
- Background: PubMed 254279Kearney BY, Fleischer BJ. Development of an instrument to measure exercise of self-care agency. Res Nurs Health. 1979 Mar;2(1):25-34. doi: 10.1002/nur.4770020105. No abstract available.
- Background: PubMed 2019177Wigal JK, Creer TL, Kotses H. The COPD Self-Efficacy Scale. Chest. 1991 May;99(5):1193-6. doi: 10.1378/chest.99.5.1193.
- Background: PubMed 7154893Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
- Background: PubMed 10377201Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax. 1999 Jul;54(7):581-6. doi: 10.1136/thx.54.7.581.
- Background: PubMed 13003946FLETCHER CM. The clinical diagnosis of pulmonary emphysema; an experimental study. Proc R Soc Med. 1952 Sep;45(9):577-84. No abstract available.
- Results publication: PubMed 23421900Goris S, Tasci S, Elmali F. The effects of training on inhaler technique and quality of life in patients with COPD. J Aerosol Med Pulm Drug Deliv. 2013 Dec;26(6):336-44. doi: 10.1089/jamp.2012.1017. Epub 2013 Feb 19.
- 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.
Gamze Muz, PhD study chair
Nevsehir Haci Bektas Veli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with COPD, run by Nevsehir Haci Bektas Veli University at 1 site 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 8 inclusion and 4 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 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
COPD Self-Efficacy Scale (CSES) (time frame: baseline to the 3 months after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04052906, which also lists 6 linked publications.
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 6 Nov 2019.