AsthmaNCT04607681
Evaluation of the Effect of Web-designed Training Developed for Asthma Patients
A study testing EDUCATION in people with Asthma, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- EDUCATION
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jul 2021to 24 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Web-designed Training Developed for Asthma Patients on Drug Compliance, Asthma Control, and Fatigue
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
Read the 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
- Being tested
- EDUCATION
- Keywords
- asthma, compliance, life quality, asthma control, web based training, asthma education
- Medical subject headings
- Asthma, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDUCATIONBehavioural
WEB BASED EDUCATION
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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"
Measured: 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
Measured: 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.
Measured: at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start21 Jul 2021
- Primary completion10 Nov 2021
- Study completion24 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EYLUL GULNUR ERDOGAN, Phd, Eskisehir Osmangazi University
- Investigators
- Ozlem Orsal, Prof, Study director, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607681
- Sponsor's protocol ID
- Eskisehir Osmangazi Universty
- Status last verified
- Sep 2022
- First submitted
- 20 Oct 2020
- Last updated
- 19 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16522452Schatz 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.
PubMed 17194469Koufopoulos 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.
PubMed 27298211Erdogan EG, Orsal O. The effect of web-designed education on medication adherence, asthma control and fatigue in patients with asthma: A randomized controlled trial. Int J Nurs Pract. 2024 Dec;30(6):e13288. doi: 10.1111/ijn.13288. Epub 2024 Jul 19.
PubMed 39031297
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Web-designed Training Developed for Asthma Patients on Drug Compliance, Asthma Control, and Fatigue
- ClinicalTrials.gov ID
- NCT04607681
- Acronym / sponsor ID
- Eskisehir Osmangazi Universty
- Conditions
- Asthma
- Keywords
- asthma, compliance, life quality, asthma control, web based training, asthma education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 10 Nov 2021 (actual)
- Study completion
- 24 Jan 2022 (actual)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 GROUP | Experimental | Behavioral: EDUCATIONPatients 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. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EDUCATIONWEB BASED EDUCATION | Behavioural | 1 GROUP |
Primary outcome
change from baseline in Medication Compliance Reporting Scaleat week 6
Time frame: baseline and 6 weeks
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
Time frame: baseline and 6 weeks
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
Time frame: baseline and 6 weeks
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
Time frame: baseline and 6 weeks
Form for evaluation of the skills of using inhalation devices
evaluating the web-based asthma education program
Time frame: at 6 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Background: PubMed 16522452Schatz 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.
- Background: PubMed 17194469Schatz 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.
- Background: PubMed 27298211Koufopoulos 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.
- Derived from this study: PubMed 39031297Erdogan EG, Orsal O. The effect of web-designed education on medication adherence, asthma control and fatigue in patients with asthma: A randomized controlled trial. Int J Nurs Pract. 2024 Dec;30(6):e13288. doi: 10.1111/ijn.13288. Epub 2024 Jul 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozlem Orsal, Prof study director
Eskisehir Osmangazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EDUCATION in people with Asthma, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in Medication Compliance Reporting Scaleat week 6 (time frame: baseline and 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04607681, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.