NCT04052906

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2019

Completed
Last Updated

November 6, 2019

Status Verified

November 1, 2019

Enrollment Period

3 months

First QC Date

August 7, 2019

Last Update Submit

November 4, 2019

Conditions

COPD

Keywords

COPDdyspneaself-efficacyself-care

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Modified Borg Dyspnea Scale

    baseline to the 3 months after intervention

  • Medical Research Council (MRC) Dyspnea Scale

    baseline to the 3 months after intervention

Study Arms (2)

Intervention Group

EXPERIMENTAL

Planned Inhaler Medication Training

Other: Training

Control Group

NO INTERVENTION

usual care

Interventions

TrainingOTHER

Planned Inhaler Medication Trainning

Intervention Group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gamze Muz

Nevşehir, 50300, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 254279BACKGROUND

  • 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.

    PMID: 2019177BACKGROUND

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

    PMID: 7154893BACKGROUND

  • 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.

    PMID: 10377201BACKGROUND

  • FLETCHER CM. The clinical diagnosis of pulmonary emphysema; an experimental study. Proc R Soc Med. 1952 Sep;45(9):577-84. No abstract available.

    PMID: 13003946BACKGROUND

  • 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.

    PMID: 23421900RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Gamze Muz, PhD

    Nevsehir Haci Bektas Veli University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 7, 2019

First Posted

August 12, 2019

Study Start

November 1, 2017

Primary Completion

February 1, 2018

Study Completion

May 1, 2018

Last Updated

November 6, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)