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NCT Number: NCT04256070

Effect of Education and Tele-consultancy Intervention Based on Watson Human Care Theory 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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Nurse's Role Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Pulmonary Function Quality of Life Respiratory Tract Diseases Self Efficacy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akdeniz University

Antalya, 07070, Turkey (Türkiye)

About this study

: 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

education and tele-consultation

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 5, 2020
Registry last updated
Jul 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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