PATIENT EDUCATIONNCT07139080
Effect of Mobile Application-Based Education on Self-Efficacy, Medication Adherence and Sleep Quality in Asthma.
A study testing Mobile education in people with PATIENT EDUCATION, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Asthma patients with recurrent airway obstruction frequently exhibit poor symptom control, characterized by treatment non-adherence and sleep-wake cycle disturbances. A nurse-led mobile health education intervention may address these challenges by enhancing collaborative disease management, enabling remote patient… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PATIENT EDUCATION
- What is being tested?
- Mobile education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 28 Apr 2025
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 18-65
- Having been diagnosed with asthma at least 6 months ago
- Being treated for asthma in oral, inhaler or injection forms
- Being literate in Turkish
- Having an Android phone on which the mobile application can be installed and being able to use the phone
- Having mobile network or wireless internet access
- Volunteering to participate in research
- Living in Ankara
Who cannot join
- Being hospitalized for asthma treatment
- Having a language barrier that hinders communication
- Being diagnosed with COPD
- Being diagnosed with a psychiatric disease
- Being on psychoactive or opioid therapy
- Being diagnosed with a sleep disorder related to non-respiratory reasons (physical and psychological) and being treated
Show all 14Show fewer
- Intervention group;
- The participant was diagnosed with a health problem requiring inpatient treatment during the study period.
- The participant withdraws from the study voluntarily.
- Inability to use the mobile application during the research
- Reading fewer than 6 theme headings in the mobile application (75% or less) and missing breathing exercises for more than 16 days (80% or less)
- Control group;
- The participant was diagnosed with a health problem requiring inpatient treatment during the study period.
- The participant withdraws from the study voluntarily.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Training and Research Hospital
Ankara, KEÇİÖREN, 06010
About this study
Official title: The Effect of Mobile Application-Based Education on Self-Efficacy, Medication Adherence and Sleep Quality in Asthma Patients.
Asthma patients with recurrent airway obstruction frequently exhibit poor symptom control, characterized by treatment non-adherence and sleep-wake cycle disturbances. A nurse-led mobile health education intervention may address these challenges by enhancing collaborative disease management, enabling remote patient monitoring, and strengthening self-management competencies.
The AstımAsistan application was designed to monitor changes in patient self-efficacy, medication adherence, and sleep quality through three core features: (1) patient education modules, (2) breathing exercise/medication reminders, and (3) mobile consultation capabilities.
Study data were collected using four instruments: (1) the Participant Information Form, (2) the Chronic Disease Self-Efficacy Scale, (3) the Medication Adherence Reporting Scale, and (4) the Pittsburgh Sleep Quality Index. The mobile education-based application was developed following the ADDIE (Analysis, Design, Development, Implementation, and Evaluation) instructional design model."
- Conditions
- PATIENT EDUCATION
- Being tested
- Mobile education
- Keywords
- Asthma, Self Efficacy, Medication Adherence, Mobile Education, Sleep
- Medical subject headings
- Asthma, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile educationBehavioural
It consists of participants who will download the mobile patient education and breathing exercise reminder program and apply it for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Education Group | Experimental | It consists of participants who will download the mobile patient education and breathing exercise reminder program and apply it for 10 weeks. Receives: Behavioral: Mobile education |
| Control Group | No intervention | This is the group of participants to be followed within the standard treatment plan. A mobile training and breathing exercise reminder program will be downloaded to patients in this group at the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic Disease Self-Efficacy
Chronic Disease Self Efficacy Scale: In this 30-item scale, each question is scored between 1 and 10 points to determine the level of self-efficacy. The total score obtained by the individual from the scale is divided by the number of items to calculate an overall self-efficacy average. The scale also has 10 subtitles. If the 30 items' average is below 7, it means the individual has low self-efficacy. If the average is 7 or above, it indicates that the individual has high self-efficacy regarding their illness and believes they can achieve their goals."
Measured: 10 weeks
Medication Adherence
The Medication Adherence Report Scale (MARS), developed by Horne and Hankins (2001), can be adapted based on disease type. The scale requires participants to indicate the frequency of occurrence for 5 specific statements in themselves. The scoring uses a Likert-type scale where: 5=never, 4=rarely, 3=sometimes, 2=often, and 1=always. The total test score is obtained by summing the scores from all items. The minimum possible score on the scale is 5, and the maximum is 25. Higher scores indicate compliance, while lower scores suggest non-compliance.
Measured: 10 weeks
Sleep Quality
PSQI is developed by Buysse et al. in 1989, this scale is used to assess sleep quality and identify factors contributing to sleep disorders. Its validity and reliability for our country were established by Ağargün et al. The scale consists of 18 scored items grouped into 7 component scores, with each item rated on a 0-3 scale. The components are:
Subjective Sleep Quality Sleep Latency Sleep Duration Habitual Sleep Efficiency Sleep Disturbances Use of Sleep Medication Daytime Dysfunction
The total scale score is calculated by summing the seven component scores. A total score of 5 or higher indicates poor sleep quality.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start1 Dec 2023
- Primary completion28 Apr 2025
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PATIENT EDUCATIONStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ezgi Yildirim, Gulhane Training and Research Hospital
- Investigators
- AYLA DEMİRTAŞ, Associate Professor, Study director, UNIVERSITY OF HEALTH SCIENCES GULHANE FACULTY OF NURSING
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139080
- Sponsor's protocol ID
- Asthma Mobil Nursing Education
- Status last verified
- Aug 2025
- First submitted
- 8 May 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobile Application-Based Education on Self-Efficacy, Medication Adherence and Sleep Quality in Asthma Patients.
- ClinicalTrials.gov ID
- NCT07139080
- Acronym / sponsor ID
- Asthma Mobil Nursing Education
- Conditions
- PATIENT EDUCATION
- Keywords
- Asthma, Self Efficacy, Medication Adherence, Mobile Education, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Gulhane Training and Research HospitalOther government
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 24 Aug 2025 (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.
Asthma patients with recurrent airway obstruction frequently exhibit poor symptom control, characterized by treatment non-adherence and sleep-wake cycle disturbances. A nurse-led mobile health education intervention may address these challenges by enhancing collaborative disease management, enabling remote patient monitoring, and strengthening self-management competencies.
The AstımAsistan application was designed to monitor changes in patient self-efficacy, medication adherence, and sleep quality through three core features: (1) patient education modules, (2) breathing exercise/medication reminders, and (3) mobile consultation capabilities.
Study data were collected using four instruments: (1) the Participant Information Form, (2) the Chronic Disease Self-Efficacy Scale, (3) the Medication Adherence Reporting Scale, and (4) the Pittsburgh Sleep Quality Index. The mobile education-based application was developed following the ADDIE (Analysis, Design, Development, Implementation, and Evaluation) instructional design model."
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Education Group | Experimental | Behavioral: Mobile educationIt consists of participants who will download the mobile patient education and breathing exercise reminder program and apply it for 10 weeks. |
| Control Group | No intervention | –This is the group of participants to be followed within the standard treatment plan. A mobile training and breathing exercise reminder program will be downloaded to patients in this group at the end of the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Being between the ages of 18-65
- Having been diagnosed with asthma at least 6 months ago
- Being treated for asthma in oral, inhaler or injection forms
- Being literate in Turkish
- Having an Android phone on which the mobile application can be installed and being able to use the phone
Key exclusion criteria (14 listed)
- Being hospitalized for asthma treatment
- Having a language barrier that hinders communication
- Being diagnosed with COPD
- Being diagnosed with a psychiatric disease
- Being on psychoactive or opioid therapy
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 |
|---|---|---|
| Mobile educationIt consists of participants who will download the mobile patient education and breathing exercise reminder program and apply it for 10 weeks. | Behavioural | Mobile Education Group |
Primary outcome
Chronic Disease Self-Efficacy
Time frame: 10 weeks
Chronic Disease Self Efficacy Scale: In this 30-item scale, each question is scored between 1 and 10 points to determine the level of self-efficacy. The total score obtained by the individual from the scale is divided by the number of items to calculate an overall self-efficacy average. The scale also has 10 subtitles. If the 30 items' average is below 7, it means the individual has low self-efficacy. If the average is 7 or above, it indicates that the individual has high self-efficacy regarding their illness and believes they can achieve their goals."
Medication Adherence
Time frame: 10 weeks
The Medication Adherence Report Scale (MARS), developed by Horne and Hankins (2001), can be adapted based on disease type. The scale requires participants to indicate the frequency of occurrence for 5 specific statements in themselves. The scoring uses a Likert-type scale where: 5=never, 4=rarely, 3=sometimes, 2=often, and 1=always. The total test score is obtained by summing the scores from all items. The minimum possible score on the scale is 5, and the maximum is 25. Higher scores indicate compliance, while lower scores suggest non-compliance.
Sleep Quality
Time frame: 10 weeks
PSQI is developed by Buysse et al. in 1989, this scale is used to assess sleep quality and identify factors contributing to sleep disorders. Its validity and reliability for our country were established by Ağargün et al. The scale consists of 18 scored items grouped into 7 component scores, with each item rated on a 0-3 scale. The components are: Subjective Sleep Quality Sleep Latency Sleep Duration Habitual Sleep Efficiency Sleep Disturbances Use of Sleep Medication Daytime Dysfunction The total scale score is calculated by summing the seven component scores. A total score of 5 or higher indicates poor sleep quality.
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 24 Aug 2025.
- 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.
AYLA DEMİRTAŞ, Associate Professor study director
UNIVERSITY OF HEALTH SCIENCES GULHANE FACULTY OF NURSING
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile education in people with PATIENT EDUCATION, run by Gulhane Training and Research Hospital 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 8 inclusion and 14 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 24 Aug 2025. 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?
Chronic Disease Self-Efficacy (time frame: 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2025.