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

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04256070
• Other study ID #: 2012-KAEK-20, Karar no: 718
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: June 21, 2022

Study information

• Verified date: July 2022
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: June 21, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Nurse's Role
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Function
• Quality of Life
• Self Efficacy

Intervention

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

Locations

Country	Name	City	State
Turkey	Akdeniz University	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pulmonary function tests	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
Other	Number of hospitalizations	It shows the number of hospitalizations of the patient during the study.	from baseline and at the end of the third months
Primary	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	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 Polatli 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