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

NCT ID: NCT04607681

Last Updated: 2022-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-21
• Study Completion Date: 2022-01-24

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

1 GROUP

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.

Group Type: EXPERIMENTAL

EDUCATION

Intervention Type: BEHAVIORAL

WEB BASED EDUCATION

2 GROUP

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

EDUCATION

WEB BASED EDUCATION

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eskisehir Osmangazi University

OTHER

Sponsor Role: lead

Responsible Party

EYLUL GULNUR ERDOGAN, Phd

PHD STUDENT

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ozlem Orsal, Prof

Role: STUDY_DIRECTOR

Eskisehir Osmangazi University

Locations

Eskisehir Osmangazi Universty

Eskişehir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 16522452 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17194469 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27298211 (View on PubMed)

Other Identifiers

Eskisehir Osmangazi Universty

Identifier Type: -

Identifier Source: org_study_id