Clinical trial NCT04607681: Evaluation of the Effect of Web-designed Training Developed for Asthma Patients
Official title: Evaluation of the Effect of Web-designed Training Developed for Asthma Patients on Drug Compliance, Asthma Control, and Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: asthma
compliance
life quality
asthma control
web based training
asthma education
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: change from baseline in Medication Compliance Reporting Scaleat week 6
timeFrame: baseline and 6 weeks
measure: change from baseline in COPD and Asthma Fatigue Scale (DAS) at week 6
timeFrame: baseline and 6 weeks
measure: change from baseline in Asthma Control Test (AKT) at week 6
timeFrame: baseline and 6 weeks
measure: change from baseline in bility to use inhalation devices at week 6
timeFrame: baseline and 6 weeks
measure: evaluating the web-based asthma education program
timeFrame: at 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Eskişehir
country: Turkey
facility: Eskisehir Osmangazi Universty
Study officials:
affiliation: Eskisehir Osmangazi University
name: Ozlem Orsal, Prof
role: STUDY_DIRECTOR
References:
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. doi: 10.1016/j.jaci.2006.01.011.
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. doi: 10.1016/j.jaci.2006.08.042. Epub 2006 Dec 27.
citation: 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.