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Effect of Education and Tele-consultancy Intervention Based on Watson Human Care Theory Individuals With COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease, Self Efficacy, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
education and tele-consultation
Sponsored by
Akdeniz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring chronic obstructive pulmonary disease, nursing, quality of life, self-efficacy, Watson's Human Care Theory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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
  • 18 years and older
  • Literate
  • Agree to participate in the research

Exclusion Criteria:

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

Sites / Locations

  • Akdeniz University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Education, tele-consultation and training booklet

Standart care, no intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

St. George's Respiratory Questionnaire
St. George's Respiratory Questionnaire (SGRQ) is known to be associated with the most commonly used scales in respiratory diseases. SGRQ is a 50-item scale under three main titles developed in 2001: symptoms (8 items), activities (16 items), effects of the disease (26 items). It is a scale that investigates the relationship between dyspnea, sputum, cough, respiratory status, and daily activity, especially in individuals with COPD. Its highest score is 100 and it expresses the highest level of negative status. Cronbach's alpha value of SGRQ was calculated as 0.88 for the whole scale, and it was found in the validity analysis that it correlated significantly with similar scales (p <0.0001). The SGRQ scale was translated into Turkish by Polatlı et al. (2013) and its validity and reliability study was conducted. Correlation of Turkish version Cronbach's alpha value was found to be 0.90.

Full Information

First Posted
February 1, 2020
Last Updated
July 3, 2022
Sponsor
Akdeniz University
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1. Study Identification

Unique Protocol Identification Number
NCT04256070
Brief Title
Effect of Education and Tele-consultancy Intervention Based on Watson Human Care Theory Individuals With COPD
Official Title
Effect of Education and Tele-consultancy Intervention Based on Watson Human Care Theory on Self-efficacy and Quality of Life Individuals With COPD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
June 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
: The research that a single-blinded randomized controlled trial, a total of 74 individuals, including 37 individual intervention and 37 individual control groups who applied to Akdeniz University Chest Diseases Polyclinic for consultation and follow-up, meeting the inclusion criteria, conducted between October 2020 - May 2022. In collecting data Information Form Based on Watson Human Care Theory, the Chronic Obstructive Pulmonary Disease Self-efficacy Scale, St. George Quality of Life Scale, and Pulmonary Function Test Form were used. Individuals in the intervention group were provided with training and consultancy based on Watson Human Care Theory, and an educational booklet prepared with current guides and expert opinions. Telephone counseling was provided in the 2nd, 4th, 6th, 8th, and 10th weeks after the first intervention in the intervention group. Routine follow-up of individuals in the control group was continued. The data of the scales in the intervention and control groups are collected in the 12th week. The individuals in the control group were given a training booklet at the end of the study. Statistical analysis of the data was done with SPSS 22.0 software package.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Self Efficacy, Quality of Life, Pulmonary Function, Nurse's Role
Keywords
chronic obstructive pulmonary disease, nursing, quality of life, self-efficacy, Watson's Human Care Theory

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Education, tele-consultation and training booklet
Arm Type
Experimental
Arm Description
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.
Arm Title
Standart care, no intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
education and tele-consultation
Intervention Description
education and tele-consultation based on Watson's Human Care Theory
Primary Outcome Measure Information:
Title
Chronic Obstructive Pulmonary Disease Self-Efficacy Scale
Description
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.
Time Frame
from baseline and at the end of the third months
Secondary Outcome Measure Information:
Title
St. George's Respiratory Questionnaire
Description
St. George's Respiratory Questionnaire (SGRQ) is known to be associated with the most commonly used scales in respiratory diseases. SGRQ is a 50-item scale under three main titles developed in 2001: symptoms (8 items), activities (16 items), effects of the disease (26 items). It is a scale that investigates the relationship between dyspnea, sputum, cough, respiratory status, and daily activity, especially in individuals with COPD. Its highest score is 100 and it expresses the highest level of negative status. Cronbach's alpha value of SGRQ was calculated as 0.88 for the whole scale, and it was found in the validity analysis that it correlated significantly with similar scales (p <0.0001). The SGRQ scale was translated into Turkish by Polatlı et al. (2013) and its validity and reliability study was conducted. Correlation of Turkish version Cronbach's alpha value was found to be 0.90.
Time Frame
from baseline and at the end of the third months
Other Pre-specified Outcome Measures:
Title
Pulmonary function tests
Description
It is known that spirometry is the best method in the evaluation of airway obstruction and COPD. After spirometry, forced vital capacity (FVC), forced expiration volume in 1 second (FEV1), FEV1 / FVC ratio values are obtained. Normal values of the FEV1 / FVC ratio between 0.7-0.8 and less than 0.65 are indicative of airway obstruction. After spirometry, forced vital capacity (FVC), forced expiration volume in 1 second (FEV1), FEV1 / FVC ratio. Normal values of the FEV1 / FVC ratio between 0.7-0.8 and less than 0.65 are indicative of airway obstruction.
Time Frame
from baseline and at the end of the third months
Title
Number of hospitalizations
Description
It shows the number of hospitalizations of the patient during the study.
Time Frame
from baseline and at the end of the third months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 18 years and older Literate Agree to participate in the research Exclusion Criteria: Not getting enough points from the Standardized Mini-Mental Test A diagnosis of malignancy (based on file information)
Facility Information:
Facility Name
Akdeniz University
City
Antalya
ZIP/Postal Code
07070
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35514131
Citation
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.
Results Reference
derived
PubMed Identifier
34495549
Citation
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.
Results Reference
derived

Learn more about this trial

Effect of Education and Tele-consultancy Intervention Based on Watson Human Care Theory Individuals With COPD

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