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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04052906
Other study ID # NevsehirHBVU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2017
Est. completion date May 1, 2018

Study information

Verified date November 2019
Source Nevsehir Haci Bektas Veli University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to evaluate the effect of planned inhaler medication training on self-care agency and self-efficacy level.


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.


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date May 1, 2018
Est. primary completion date February 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Training
Planned Inhaler Medication Trainning

Locations

Country Name City State
Turkey Gamze Muz Nevsehir

Sponsors (1)

Lead Sponsor Collaborator
Nevsehir Haci Bektas Veli University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View Citation

Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81. — View Citation

FLETCHER CM. The clinical diagnosis of pulmonary emphysema; an experimental study. Proc R Soc Med. 1952 Sep;45(9):577-84. — View Citation

Göris 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. — View 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. — View Citation

Wigal JK, Creer TL, Kotses H. The COPD Self-Efficacy Scale. Chest. 1991 May;99(5):1193-6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. baseline to the 3 months after intervention
Primary 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. baseline to the 3 months after intervention
Secondary 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 baseline to the 3 months after intervention
Secondary 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. baseline to the 3 months after intervention
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