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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
EDUCATION
Sponsored by
Eskisehir Osmangazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma focused on measuring asthma, compliance, life quality, asthma control, web based training, asthma education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Eskisehir Osmangazi Universty

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1 GROUP

2 GROUP

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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"
change from baseline in bility to use inhalation devices at week 6
Form for evaluation of the skills of using inhalation devices
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.

Secondary Outcome Measures

Full Information

First Posted
October 20, 2020
Last Updated
September 16, 2022
Sponsor
Eskisehir Osmangazi University
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1. Study Identification

Unique Protocol Identification Number
NCT04607681
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 21, 2021 (Actual)
Primary Completion Date
November 10, 2021 (Actual)
Study Completion Date
January 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eskisehir Osmangazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, compliance, life quality, asthma control, web based training, asthma education

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 GROUP
Arm Type
Experimental
Arm Description
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.
Arm Title
2 GROUP
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
EDUCATION
Intervention Description
WEB BASED EDUCATION
Primary Outcome Measure Information:
Title
change from baseline in Medication Compliance Reporting Scaleat week 6
Description
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.
Time Frame
baseline and 6 weeks
Title
change from baseline in COPD and Asthma Fatigue Scale (DAS) at week 6
Description
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.
Time Frame
baseline and 6 weeks
Title
change from baseline in Asthma Control Test (AKT) at week 6
Description
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"
Time Frame
baseline and 6 weeks
Title
change from baseline in bility to use inhalation devices at week 6
Description
Form for evaluation of the skills of using inhalation devices
Time Frame
baseline and 6 weeks
Title
evaluating the web-based asthma education program
Description
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.
Time Frame
at 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ozlem Orsal, Prof
Organizational Affiliation
Eskisehir Osmangazi University
Official's Role
Study Director
Facility Information:
Facility Name
Eskisehir Osmangazi Universty
City
Eskişehir
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16522452
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.
Results Reference
background
PubMed Identifier
17194469
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.
Results Reference
background
PubMed Identifier
27298211
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.
Results Reference
background

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

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