Evaluation of the Effect of Web-designed Training Developed for Asthma Patients

NCT04607681 | Completed

• 1 other identifier: Eskisehir Osmangazi Universty
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The study is an experimental study with pre-test-post-test control group in order to determine the effect of web-designed training developed for asthma patients on drug compliance, asthma control, and fatigue

Conditions

Asthma

Keywords

asthma; compliance; life quality; asthma control; web based training; asthma education

Outcome Measures

Primary Outcomes (5)

• change from baseline in Medication Compliance Reporting Scaleat week 6

  Medication Compliance Reporting Scale Participants are asked to indicate the frequency of the 5 statements in each of them. The scale is evaluated with a 5-point Likert type such that 5 = never, 4 = rarely, 3 = sometimes, 2 = often and 1 = always. The total test score is obtained by summing the scores obtained from the items. The scores obtained from the scale range from 5 to 25. An increase in the obtained scores indicates compatibility, and a decrease in scores indicates incompatibility.

  baseline and 6 weeks

• change from baseline in COPD and Asthma Fatigue Scale (DAS) at week 6

  COPD and Asthma Fatigue Scale (DAS) The scale consists of 12 items, and a Likert type rating (1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5 = very often) is used for its answers. In calculating the scale score, the first 10 questions correspond to never = 1 point, rarely = 2 points, sometimes = 3 points, often = 4 points, very often = 5 points, and in the 11th and 12th questions never = 5 points, rarely = 4 points. , sometimes = 3 points, often = 2 points, very often = 1. The total raw score is determined by adding the scores of each item and the raw scores are converted into a total scale score between 0-100. The higher the score obtained from the scale indicates that the fatigue level of the person is high.

  baseline and 6 weeks

• change from baseline in Asthma Control Test (AKT) at week 6

  Asthma Control Test (AKT); This scale consists of five Likert type and consists of five questions. The maximum score of this test is 25 and the minimum score is 5, while 25 points are "full control", 20-24 points "good control" and a score of less than 19 is considered "uncontrolled"

  baseline and 6 weeks

• change from baseline in bility to use inhalation devices at week 6

  Form for evaluation of the skills of using inhalation devices

  baseline and 6 weeks

• evaluating the web-based asthma education program

  Opinion Form Regarding the Web Based Asthma Education Program This form contains 20 questions prepared to determine the views of asthma patients on the web-based asthma education program.

  at 6 weeks

Study Arms (2)

1 GROUP

EXPERIMENTAL

Patients who agree to participate in the study will be informed about the study and their written and verbal consent will be obtained. At this stage, which will last 6 weeks for each patient; * On the first day, the patients will be evaluated first by filling the "Individual Descriptive Features Form, Information Need Determination Question Form, COPD and Asthma Fatigue Scale, Medication Compliance Notification Scale, Asthma Control Test (ACT), Form for evaluation of the skills of using inhalation devices", * In order for the patients in the intervention group to use the web-based asthma education program, a web-based asthma education program will be introduced by giving their username and password. After 6 weeks of training, second data will be collected on the web in the intervention group.

Behavioral: EDUCATION

2 GROUP

NO INTERVENTION

Written and verbal consents will be obtained from patients who agree to participate in the study by providing information about the study. At this stage, which will take 6 weeks for each patient; On the first day, the patients will first be evaluated by filling the "Individual Descriptive Characteristics Form, Information Requirement Determination Question Form, COPD and Asthma Fatigue Scale, Medication Compliance Notification Scale, Asthma Control Test (ACT), Form for evaluation of the skills of using inhalation devices", Second data after 6 weeks will be collected in the control group via Google form or phone call

Interventions

EDUCATION BEHAVIORAL

WEB BASED EDUCATION

1 GROUP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and over,
• Those who have been diagnosed with asthma for at least one year
• Those with poor asthma control
• Using at least one asthma medication
• Not having a communication problem, such as inability to understand/speak Turkish, that would prevent participating in the research or receiving training,
• Being literate,
• Having an internet connection at home or on their phone,
• Having and using a computer, tablet or smart phone,
• Patients who accepted to participate in the study voluntarily formed the sample of the study.

You may not qualify if:

• No internet connection at home or on their phone,
• Do not know how to use the Internet and computer,
• Having a communication problem, such as inability to understand/speak Turkish, that would prevent participating in the research or receiving training,
• Illiterate,
• Diagnosed with another respiratory system disease,
• Diagnosed with cancer or undergoing cancer treatment,
• Those who have been diagnosed with or have had COVID-19,
• Individuals with a psychiatric illness were not included in the study.

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Eskisehir Osmangazi Universty

Eskişehir, Turkey (Türkiye)

Location

Related Publications (3)

• Schatz M, Sorkness CA, Li JT, Marcus P, Murray JJ, Nathan RA, Kosinski M, Pendergraft TB, Jhingran P. Asthma Control Test: reliability, validity, and responsiveness in patients not previously followed by asthma specialists. J Allergy Clin Immunol. 2006 Mar;117(3):549-56. doi: 10.1016/j.jaci.2006.01.011.

  PMID: 16522452 BACKGROUND

• Schatz M, Zeiger RS, Drane A, Harden K, Cibildak A, Oosterman JE, Kosinski M. Reliability and predictive validity of the Asthma Control Test administered by telephone calls using speech recognition technology. J Allergy Clin Immunol. 2007 Feb;119(2):336-43. doi: 10.1016/j.jaci.2006.08.042. Epub 2006 Dec 27.

  PMID: 17194469 BACKGROUND

• Koufopoulos JT, Conner MT, Gardner PH, Kellar I. A Web-Based and Mobile Health Social Support Intervention to Promote Adherence to Inhaled Asthma Medications: Randomized Controlled Trial. J Med Internet Res. 2016 Jun 13;18(6):e122. doi: 10.2196/jmir.4963.

  PMID: 27298211 BACKGROUND

MeSH Terms

Conditions

Asthma; Patient Compliance

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Ozlem Orsal, Prof

  Eskisehir Osmangazi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD STUDENT

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 29, 2020
• Study Start: July 21, 2021
• Primary Completion: November 10, 2021
• Study Completion: January 24, 2022
• Last Updated: September 19, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)