NCT04256070

Brief Summary

This study aims to investigate the effect of education and tele-consultancy intervention based on Watson's Human Care Theory on self-efficacy and quality of life of individuals with COPD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Oct 2020

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

First Submitted

Initial submission to the registry

February 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2022

Completed
Last Updated

July 7, 2022

Status Verified

July 1, 2022

Enrollment Period

1.6 years

First QC Date

February 1, 2020

Last Update Submit

July 3, 2022

Conditions

Chronic Obstructive Pulmonary DiseaseSelf EfficacyQuality of LifePulmonary FunctionNurse's Role

Keywords

chronic obstructive pulmonary diseasenursingquality of lifeself-efficacyWatson's Human Care Theory

Outcome Measures

Primary Outcomes (1)

  • Chronic Obstructive Pulmonary Disease Self-Efficacy Scale

    To measure self-efficacy in Chronic Obstructive Pulmonary Disease (COPD), Wigal et al. (1991) developed The Chronic Obstructive Pulmonary Disease Self-Efficacy Scale. The total score is calculated by the score of each of the answers given. There are 34 items in the total of the subtitles, a minimum of 34 points and a maximum of 170 points. High scores indicate that the level of self-efficacy is high. To find the overall score of the subscales, the total score is divided by the number of items that make up the subscale. In comparison, if there is an increase in score in the posttest compared to the pretest, it is interpreted that the degree of confidence in managing breathing difficulties or avoiding increased. By translating the scale into Turkish, Kara and Mirici (2002) tested its validity and reliability. Cronbach's alpha value in the original version of the scale is 0.95; Cronbach's alpha value of the Turkish version was found to be 0.94.

    from baseline and at the end of the third months

Secondary Outcomes (1)

  • St. George's Respiratory Questionnaire

    from baseline and at the end of the third months

Other Outcomes (2)

  • Pulmonary function tests

    from baseline and at the end of the third months

  • Number of hospitalizations

    from baseline and at the end of the third months

Study Arms (2)

Education, tele-consultation and training booklet

EXPERIMENTAL

* Informed Consent Form will be taken in written from those who agree to participate in the research. * In the first intervention, Information Form Based on Watson's Human Care Theory, Chronic Obstructive Pulmonary Disease Self-efficacy Scale, St. George Quality of Life Scale, Respiratory Function Test Form data will be collected. Subsequently, education, counseling nursing care and education booklet based on Watson's Human Care Theory will be given. Teleconsultation based on Watson's Human Care Theory will be given during the intervention at weeks 2, 4, 6, 8 and 10. * 24-hour tele-consultancy will be given on subjects determined for the management of COPD in case of necessity at the request of the individual. * In the last intervention in the 12th week, face to face with the individual, Consultancy based on Watson Human Care Theory, Self-efficacy Scale, St. George Quality of Life Scale, Respiratory Function Test Form, Telephone Interview Evaluation Form will be applied.

Behavioral: education and tele-consultation

Standart care, no intervention

NO INTERVENTION

* Informed Consent Form will be taken in writing from those who agree to participate in the research. * At the first meeting, Information Form Based on Watson Human Care Theory, Self-efficacy Scale, St. George Quality of Life Scale, Respiratory Function Test Form data will be collected. Interventions will not be applied to individuals in this group and routine treatment and follow-up will continue. \- COPD Self-efficacy Scale, face-to-face meeting at the end of the 12th week. George Quality of Life Scale, Respiratory Function Test Form will be repeated. A training booklet for COPD management will be provided.

Interventions

education and tele-consultationBEHAVIORAL

education and tele-consultation based on Watson's Human Care Theory

Education, tele-consultation and training booklet

Eligibility Criteria

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

You may qualify if:

  • Who has been diagnosed with COPD for more than 6 months
  • No exacerbation for at least 4 weeks, stable period
  • Followed up at Akdeniz University Hospital Chest Diseases Polyclinic
  • Clear conscious (evaluated by Sandartize Mini-Mental Test higher than 23 points)
  • No verbal communication barriers
  • Individual phone owner
  • No hearing or communication problems on the phone
  • years and older
  • Literate
  • Agree to participate in the research

You may not qualify if:

  • Not getting enough points from the Standardized Mini-Mental Test
  • A diagnosis of malignancy (based on file information)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, 07070, Turkey (Türkiye)

Location

Related Publications (2)

  • Cross AJ, Thomas D, Liang J, Abramson MJ, George J, Zairina E. Educational interventions for health professionals managing chronic obstructive pulmonary disease in primary care. Cochrane Database Syst Rev. 2022 May 6;5(5):CD012652. doi: 10.1002/14651858.CD012652.pub2.

    PMID: 35514131DERIVED

  • Poot CC, Meijer E, Kruis AL, Smidt N, Chavannes NH, Honkoop PJ. Integrated disease management interventions for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2021 Sep 8;9(9):CD009437. doi: 10.1002/14651858.CD009437.pub3.

    PMID: 34495549DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Educational Status

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, PhD student

Study Record Dates

First Submitted

February 1, 2020

First Posted

February 5, 2020

Study Start

October 1, 2020

Primary Completion

April 30, 2022

Study Completion

June 21, 2022

Last Updated

July 7, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)