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

Asthma Clinical Trial

Official title:

Evaluation of the Effect of Web-designed Training Developed for Asthma Patients on Drug Compliance, Asthma Control, and Fatigue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04607681
• Other study ID #: Eskisehir Osmangazi Universty
• Status: Completed
• Phase: N/A
• Start date: July 21, 2021
• Est. completion date: January 24, 2022

Study information

• Verified date: September 2022
• Source: Eskisehir Osmangazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

In the first stage, it is aimed to develop, implement and evaluate a web designed asthma education program for asthma patients. In the second stage, it is to evaluate the effect of the web-designed education program developed for asthmatic patients on drug ompliance, asthma control, and fatigue The population of the study consists of patients diagnosed with asthma who are registered in Family Health Centers in Eskişehir. The individuals that constitute the target group in the study will be determined through the records of patients diagnosed with asthma registered in the family health center or the list of patients in the J45-Asthma and J46 Status Asthmaticus ICD codes. The sample of the study will be the patients who meet the criteria for inclusion in the study. G power analysis program was used to determine the sample size. The research will be conducted in two groups, an intervention and a control group. The sample size of the research was found to be 200.

In collecting research data; The personal descriptive characteristics form prepared by the researcher, the questionnaire for determining the information needs, Form for evaluation of the skills of using inhalation devices and the opinion form regarding the web-based asthma education program will be used. At the same time, COPD and asthma fatigue scale, drug compliance reporting scale and Asthma Control Test (AKT) will be used.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 24, 2022
• Est. primary completion date: November 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• EDUCATION
WEB BASED EDUCATION

Locations

Country	Name	City	State
Turkey	Eskisehir Osmangazi Universty	Eskisehir

Sponsors (1)

Lead Sponsor	Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. Epub 2006 Dec 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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