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Completed

NCT Number: NCT04052906

The Effect On Self-Care and Self-Efficacy of Inhaler Training in COPD

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

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gamze Muz

Nevşehir, 50300, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Training

Other

Planned Inhaler Medication Trainning

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Modified Borg Dyspnea Scale

    Time frame: baseline to the 3 months after intervention

    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

  2. Medical Research Council (MRC) Dyspnea Scale

    Time frame: baseline to the 3 months after intervention

    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.

Sponsors and collaborators

Lead sponsor

Nevsehir Haci Bektas Veli University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 12, 2019
Registry last updated
Nov 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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