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

July 3, 2022 updated by: Şehnaz Kaya, Akdeniz University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey, 07070
        • Akdeniz University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Education, tele-consultation and training booklet
  • 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
education and tele-consultation based on Watson's Human Care Theory
No Intervention: Standart care, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic Obstructive Pulmonary Disease Self-Efficacy Scale
Time Frame: from baseline and at the end of the third months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
St. George's Respiratory Questionnaire
Time Frame: from baseline and at the end of the third months

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.
from baseline and at the end of the third months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary function tests
Time Frame: from baseline and at the end of the third months
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.
from baseline and at the end of the third months
Number of hospitalizations
Time Frame: from baseline and at the end of the third months
It shows the number of hospitalizations of the patient during the study.
from baseline and at the end of the third months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akdeniz University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

June 21, 2022

Study Registration Dates

First Submitted

February 1, 2020

First Submitted That Met QC Criteria

February 3, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

July 7, 2022

Last Update Submitted That Met QC Criteria

July 3, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-KAEK-20, Karar no: 718

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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