Clinical trial NCT04052906: The Effect On Self-Care and Self-Efficacy of Inhaler Training in COPD
Official title: The Effect On Self-Care and Self-Efficacy of Inhaler Training in COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: COPD
dyspnea
self-efficacy
self-care
Lead sponsor: Nevsehir Haci Bektas Veli University
Sponsor class: OTHER
First posted: 2019-08-12
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: COPD Self-Efficacy Scale (CSES)
timeFrame: baseline to the 3 months after intervention
measure: Self-Care Agency Scale
timeFrame: baseline to the 3 months after intervention
Secondary outcomes:
measure: Modified Borg Dyspnea Scale
timeFrame: baseline to the 3 months after intervention
measure: Medical Research Council (MRC) Dyspnea Scale
timeFrame: baseline to the 3 months after intervention
Other outcomes:
Locations:
city: Nevşehir
country: Turkey
facility: Gamze Muz
Study officials:
affiliation: Nevsehir Haci Bektas Veli University
name: Gamze Muz, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: Wigal JK, Creer TL, Kotses H. The COPD Self-Efficacy Scale. Chest. 1991 May;99(5):1193-6. doi: 10.1378/chest.99.5.1193.
citation: Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
citation: Bestall 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.
citation: FLETCHER CM. The clinical diagnosis of pulmonary emphysema; an experimental study. Proc R Soc Med. 1952 Sep;45(9):577-84. No abstract available.
citation: Goris 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.