HypertensionNCT07556419
Development of a Mobile Application Called TansiyoRitim for Hypertension Patients
A study testing Mobile application in people with Hypertension and Mobile Application, run by Kafkas University at 1 site in Turkey (Türkiye).
Trial summary
Based on King's Theory of Goal Success, this project is designed to develop a mobile application called TansiyoRitim for individuals over the age of 18 diagnosed with hypertension. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hypertension, Mobile Application, Blood Pressure Control
- What is being tested?
- Mobile application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2026to 20 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with hypertension at least 1 year prior to enrollment
- Currently using antihypertensive medication
- Able to use a smartphone
- Able to measure blood pressure at home
- No severe visual or hearing impairment
- Able to communicate in Turkish
- Literate
- Willing to participate and provide informed consent
Who cannot join
- Age under 18 or over 85 years
- Presence of severe comorbid chronic disease affecting participation
- Severe physical or cognitive impairment preventing participation
- Body mass index (BMI) ≥ 30 kg/m²
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kafkas University
Kars, 36000
+905059809499, rabia_byrmby36@outlook.com
About this study
Official title: The Effect of a Mobile Application Developed for Hypertension Patients on Blood Pressure Control, Treatment Adherence, and Self-Efficacy: A Randomized Controlled Trial
Based on King's Theory of Goal Success, this project is designed to develop a mobile application called TansiyoRitim for individuals over the age of 18 diagnosed with hypertension. The research consists of the following phases: creating educational content, designing the mobile application, and evaluating the application and its effectiveness. Within the scope of the research, participants' blood pressure control, self-efficacy levels, and treatment adherence behaviors will be assessed using valid and reliable measurement tools, and the goal is to support these behaviors through the developed mobile health application. Participants' clinical treatment processes, pharmacological treatment adjustments planned by the physician, and changes in medication dosages will be excluded from the scope of the project. No intervention will be made in the medical treatment currently being administered during the study; participants' routine clinical follow-up and treatment processes will continue within the framework of standard care. Only educational and mobile app-based supportive interventions will be implemented within the scope of the research.
Read the detailed description
Hypertension, a systemic disease characterized by persistently high blood pressure, is a significant health problem due to its widespread prevalence in the population and the serious complications that can develop if left uncontrolled. In the treatment of hypertension, maintaining blood pressure control is crucial for treatment success. In addition to pharmacological methods, lifestyle modifications such as weight management, smoking cessation, regular exercise, sleep hygiene, salt restriction, balanced nutrition, and stress reduction are also commonly used. The literature reports that interventions aimed at improving the health behaviors of hypertensive patients, presented through methods that encourage active participation and are enriched with digital tools, are more effective than traditional methods in terms of learning outcomes and lasting behavioral change. This study aims to evaluate the effect of a mobile health application structured on King's Goal Achievement Theory on blood pressure control, treatment adherence, and self-efficacy in hypertensive patients. The unique aspect of this research is that the mobile application developed for hypertensive patients offers a learning and care approach that supports mutually goal-oriented interaction between the individual and the system, rather than simply being an information-providing tool. This project, the first of its kind to be conducted under nurse leadership and unique to the culture of the province where the study is taking place, features a mobile application for blood pressure control. Another unique aspect is the development of a collaborative model that contributes to the multidisciplinary management of hypertension through an individualized care protocol structured based on King's Goal Achievement Theory, developed under nurse leadership. These achievements make our project unique and innovative for our country. The research will be conducted in a hospital in Kars using a randomized controlled experimental design including pre-test, post-test, and interim measurements. 160 participants, determined by power analysis, will be randomly assigned to the mobile application group (n=80) and the control group (n=80) via a computer-based randomization list created using the R program. Participants in the mobile app group will begin using the TansiyoRitim mobile app, which is available for download on Google Play and the App Store. The app is structured according to the theoretical components of King's Theory of Targeted Success and is designed to promote behavior change in patients with hypertension. The study outcomes will be evaluated using a Demographic Information Form, a Blood Pressure Monitoring Form, the Hill-Bone Hypertension Treatment Adherence Scale, the Hypertension Self-Efficacy Scale, and a Mobile Application Usability Scale. This project aims to generate scientific evidence regarding the effectiveness of a mobile health application developed for hypertension patients, support individuals' active participation in their health processes through the mobile application, contribute to the dissemination of digital health-based approaches in academic and applied fields, and share the results of this project in international literature.
- Conditions
- Hypertension, Mobile Application, Blood Pressure Control, Treatment Adherence, Self-Efficacy
- Being tested
- Mobile application, control group
- Keywords
- Hypertension, mobile application, blood pressure control, Treatment Adherence, Self-Efficacy, King's Goal Achievement Theory
- Medical subject headings
- Hypertension, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile applicationBehavioural
The mobile application will be developed for patients with hypertension. It will include educational videos, educational texts, and reminders.
control groupBehavioural
The control group will not be interfered with.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Application Group | Experimental | Patients meeting the sampling inclusion criteria will be informed about the study and invited to participate. Verbal and written consent will be obtained from patients who meet the inclusion criteria and agree to participate in the study. The follow-up period for patients included in the mobile application process varies in the literature from 1.5 months (Yildirim Keskin et al., 2025), 3 months (Lee et al., 2024), to 6 months (Bozorgi et al., 2021). Accordingly, the duration of the application has been determined as 3 months (12 weeks). Follow-up periods vary in the literature. To determine the appropriate follow-up time for patients, studies in the literature were reviewed. The follow-up period in these studies ranges from 2 to 8 weeks (Bozorgi et al., 2021; Lee et al., 2024; Yildirim Keskin et al., 2025). Therefore, the follow-up period in this study has been determined as 2 weeks. A total of 7 measurements will be taken: pre-test, post-test, and 5 interim measurements. Receives: Behavioral: Mobile application |
| Control Group | Experimental | Patients meeting the sampling inclusion criteria will be informed about the study and invited to participate. Verbal and written consent will be obtained from patients who meet the inclusion criteria and agree to participate. No intervention will be performed on the patients. Therefore, the follow-up period in this study has been set at 2 weeks. A total of 7 measurements will be taken: a pre-test, a post-test, and 5 interim measurements. Post-tests will be conducted after 3 months. Receives: Behavioral: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic Information Form
This form, developed as a result of a literature review, contains 19 questions. Before the mobile application is launched, this form will be used to collect patients' sociodemographic data.
Measured: At baseline
Blood Pressure Measurement and Monitoring Form
All blood pressure measurements will be taken by the researcher using a calibrated mercury manometer (blood pressure monitor). The first measurement will be taken from both arms. If a difference of more than 10 mmHg is recorded between the arms, then all subsequent blood pressure measurements will be taken from the arm with the higher blood pressure reading. The average of the three blood pressure measurements taken from the identified arm will then be used for evaluation. Patients' blood pressure values will be measured every two weeks for three months starting from the beginning of using the mobile application, and recorded in the relevant form logbook for evaluation.
Measured: From baseline to Month 3
Hill-Bone Hypertension Treatment Adherence Scale (HBHTTUÖ)
The Cronbach's alpha value of the scale was determined to be 0.83. The scale consists of a total of 14 questions using a 4-point Likert scale. Answers are scored as (1) "Never", (2) "Sometimes", (3) "Most of the time" and (4) "Always". All questions except question 6 are negative questions. The scale consists of appointment, medical and nutritional subscales in addition to the total score. The overall score of the scale ranges from 0 to 42. When a patient answers all questions positively and receives a score of "0", they are considered fully compliant. The lower the score, the higher the compliance. After obtaining informed consent from the participants, the relevant scale will be administered as a pre-test. Once the mobile application usage process is complete, the same scale will be repeated as a post-test in the third month of the application.
Measured: Baseline and Month 3
Hypertension Self-Efficacy Scale
The scale consists of 20 items. The original scale uses a 4-point Likert scale, with each item ranging from "not at all appropriate" (1 point) to "very appropriate" (4 points). Items are scored between 1 and 4 points. A total score of 20 to 80 points is obtained from the scale. A higher total score indicates a higher level of self-efficacy in hypertension. The Cronbach's alpha reliability coefficient of the scale was found to be 0.78. After obtaining informed consent from the participants, the relevant scale will be administered as a pre-test. Once the mobile application usage process is complete, the same scale will be repeated as a post-test in the third month of the application.
Measured: Baseline and Month 3
Secondary outcomes (2)
Mobile Application Usability Scale
The scale is a 7-point Likert type scale, consisting of 10 factors, each with 4 items, for a total of 40 items. As the score obtained from the scale increases, usability also increases. In the study, it was determined that the Cronbach alpha coefficient values ranged from 0.74 to 0.94.
Measured: The Mobile Application Usability Scale will be used for both expert and patient evaluations. Outcome 1 (Experts): At baseline Outcome 2 (Patients): At Month 3
DISCERN (Quality Criteria for Consumer Health Information)
The DISCERN scale was developed to evaluate the quality of educational materials designed to inform individuals about health and treatment options. Each question is scaled from 1 to 5 points, from Yes to No. A definite yes answer receives 5 points, while a definite no answer receives 1 point. The total number of responses is used to obtain a DISCERN score ranging from 15 to 75, with scores between 16 and 26 classified as very inadequate. Item 16, which provides the overall assessment, is further evaluated as follows: 63-75 points excellent, 51-62 points good, 39-50 points average, and 27-38 points inadequate. The quality and reliability of training materials will be evaluated by experts using a standardized scale at baseline, before integration into the mobile application. Higher scores indicate better quality and reliability.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion20 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Model description
- The application will be designed by a mobile application specialist in collaboration with the researcher. The program's feasibility will be tested for one month with eight hypertensive patients. The application will be installed on the patients' mobile phones by the researcher. On the first day, each patient will be informed about how to use the mobile application and how to create a username and password. Patients will be asked to enter the measurement time and value in the blood pressure section when they measure their blood pressure. Patients will receive a notification via the mobile application once a day to encourage them to use it.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafkas University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabia BAYRAMBEY, Kafkas University
- Investigators
- Rabia Bayrambey, 1, Principal investigator, Kafkas UniversityYeliz Akkuş, 2, Study director, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07556419
- Sponsor's protocol ID
- 80576354-050-99/886
- Status last verified
- Apr 2026
- First submitted
- 28 Mar 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared to protect participant confidentiality. Due to the sensitive nature of the health data collected via the digital health application, our ethical board approval restricts data access solely to the primary research team.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Mobile Application Developed for Hypertension Patients on Blood Pressure Control, Treatment Adherence, and Self-Efficacy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07556419
- Acronym / sponsor ID
- 80576354-050-99/886
- Conditions
- Hypertension, Mobile Application, Blood Pressure Control, Treatment Adherence, Self-Efficacy
- Keywords
- Hypertension, mobile application, blood pressure control, Treatment Adherence, Self-Efficacy, King's Goal Achievement Theory
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Kafkas UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 20 Mar 2027 (estimated)
- First posted
- 29 Apr 2026 (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.
Based on King's Theory of Goal Success, this project is designed to develop a mobile application called TansiyoRitim for individuals over the age of 18 diagnosed with hypertension. The research consists of the following phases: creating educational content, designing the mobile application, and evaluating the application and its effectiveness. Within the scope of the research, participants' blood pressure control, self-efficacy levels, and treatment adherence behaviors will be assessed using valid and reliable measurement tools, and the goal is to support these behaviors through the developed mobile health application. Participants' clinical treatment processes, pharmacological treatment adjustments planned by the physician, and changes in medication dosages will be excluded from the scope of the project. No intervention will be made in the medical treatment currently being administered during the study; participants' routine clinical follow-up and treatment processes will continue within the framework of standard care. Only educational and mobile app-based supportive interventions will be implemented within the scope of the research.
Detailed description
Hypertension, a systemic disease characterized by persistently high blood pressure, is a significant health problem due to its widespread prevalence in the population and the serious complications that can develop if left uncontrolled. In the treatment of hypertension, maintaining blood pressure control is crucial for treatment success. In addition to pharmacological methods, lifestyle modifications such as weight management, smoking cessation, regular exercise, sleep hygiene, salt restriction, balanced nutrition, and stress reduction are also commonly used. The literature reports that interventions aimed at improving the health behaviors of hypertensive patients, presented through methods that encourage active participation and are enriched with digital tools, are more effective than traditional methods in terms of learning outcomes and lasting behavioral change. This study aims to evaluate the effect of a mobile health application structured on King's Goal Achievement Theory on blood pressure control, treatment adherence, and self-efficacy in hypertensive patients. The unique aspect of this research is that the mobile application developed for hypertensive patients offers a learning and care approach that supports mutually goal-oriented interaction between the individual and the system, rather than simply being an information-providing tool. This project, the first of its kind to be conducted under nurse leadership and unique to the culture of the province where the study is taking place, features a mobile application for blood pressure control. Another unique aspect is the development of a collaborative model that contributes to the multidisciplinary management of hypertension through an individualized care protocol structured based on King's Goal Achievement Theory, developed under nurse leadership. These achievements make our project unique and innovative for our country. The research will be conducted in a hospital in Kars using a randomized controlled experimental design including pre-test, post-test, and interim measurements. 160 participants, determined by power analysis, will be randomly assigned to the mobile application group (n=80) and the control group (n=80) via a computer-based randomization list created using the R program. Participants in the mobile app group will begin using the TansiyoRitim mobile app, which is available for download on Google Play and the App Store. The app is structured according to the theoretical components of King's Theory of Targeted Success and is designed to promote behavior change in patients with hypertension. The study outcomes will be evaluated using a Demographic Information Form, a Blood Pressure Monitoring Form, the Hill-Bone Hypertension Treatment Adherence Scale, the Hypertension Self-Efficacy Scale, and a Mobile Application Usability Scale. This project aims to generate scientific evidence regarding the effectiveness of a mobile health application developed for hypertension patients, support individuals' active participation in their health processes through the mobile application, contribute to the dissemination of digital health-based approaches in academic and applied fields, and share the results of this project in international literature.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The application will be designed by a mobile application specialist in collaboration with the researcher. The program's feasibility will be tested for one month with eight hypertensive patients. The application will be installed on the patients' mobile phones by the researcher. On the first day, each patient will be informed about how to use the mobile application and how to create a username and password. Patients will be asked to enter the measurement time and value in the blood pressure section when they measure their blood pressure. Patients will receive a notification via the mobile application once a day to encourage them to use it.
| Arm | Type | Receives |
|---|---|---|
| Mobile Application Group | Experimental | Behavioral: Mobile applicationPatients meeting the sampling inclusion criteria will be informed about the study and invited to participate. Verbal and written consent will be obtained from patients who meet the inclusion criteria and agree to participate in the study. The follow-up period for patients included in the mobile application process varies in the literature from 1.5 months (Yildirim Keskin et al., 2025), 3 months (Lee et al., 2024), to 6 months (Bozorgi et al., 2021). Accordingly, the duration of the application has been determined as 3 months (12 weeks). Follow-up periods vary in the literature. To determine the appropriate follow-up time for patients, studies in the literature were reviewed. The follow-up period in these studies ranges from 2 to 8 weeks (Bozorgi et al., 2021; Lee et al., 2024; Yildirim Keskin et al., 2025). Therefore, the follow-up period in this study has been determined as 2 weeks. A total of 7 measurements will be taken: pre-test, post-test, and 5 interim measurements. |
| Control Group | Experimental | Behavioral: control groupPatients meeting the sampling inclusion criteria will be informed about the study and invited to participate. Verbal and written consent will be obtained from patients who meet the inclusion criteria and agree to participate. No intervention will be performed on the patients. Therefore, the follow-up period in this study has been set at 2 weeks. A total of 7 measurements will be taken: a pre-test, a post-test, and 5 interim measurements. Post-tests will be conducted after 3 months. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosed with hypertension at least 1 year prior to enrollment
- Currently using antihypertensive medication
- Able to use a smartphone
- Able to measure blood pressure at home
- No severe visual or hearing impairment
Key exclusion criteria (4 listed)
- Age under 18 or over 85 years
- Presence of severe comorbid chronic disease affecting participation
- Severe physical or cognitive impairment preventing participation
- Body mass index (BMI) ≥ 30 kg/m²
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 applicationThe mobile application will be developed for patients with hypertension. It will include educational videos, educational texts, and reminders. | Behavioural | Mobile Application Group |
| control groupThe control group will not be interfered with. | Behavioural | Control Group |
Primary outcome
Demographic Information Form
Time frame: At baseline
This form, developed as a result of a literature review, contains 19 questions. Before the mobile application is launched, this form will be used to collect patients' sociodemographic data.
Blood Pressure Measurement and Monitoring Form
Time frame: From baseline to Month 3
All blood pressure measurements will be taken by the researcher using a calibrated mercury manometer (blood pressure monitor). The first measurement will be taken from both arms. If a difference of more than 10 mmHg is recorded between the arms, then all subsequent blood pressure measurements will be taken from the arm with the higher blood pressure reading. The average of the three blood pressure measurements taken from the identified arm will then be used for evaluation. Patients' blood pressure values will be measured every two weeks for three months starting from the beginning of using the mobile application, and recorded in the relevant form logbook for evaluation.
Hill-Bone Hypertension Treatment Adherence Scale (HBHTTUÖ)
Time frame: Baseline and Month 3
The Cronbach's alpha value of the scale was determined to be 0.83. The scale consists of a total of 14 questions using a 4-point Likert scale. Answers are scored as (1) "Never", (2) "Sometimes", (3) "Most of the time" and (4) "Always". All questions except question 6 are negative questions. The scale consists of appointment, medical and nutritional subscales in addition to the total score. The overall score of the scale ranges from 0 to 42. When a patient answers all questions positively and receives a score of "0", they are considered fully compliant. The lower the score, the higher the compliance. After obtaining informed consent from the participants, the relevant scale will be administered as a pre-test. Once the mobile application usage process is complete, the same scale will be repeated as a post-test in the third month of the application.
Hypertension Self-Efficacy Scale
Time frame: Baseline and Month 3
The scale consists of 20 items. The original scale uses a 4-point Likert scale, with each item ranging from "not at all appropriate" (1 point) to "very appropriate" (4 points). Items are scored between 1 and 4 points. A total score of 20 to 80 points is obtained from the scale. A higher total score indicates a higher level of self-efficacy in hypertension. The Cronbach's alpha reliability coefficient of the scale was found to be 0.78. After obtaining informed consent from the participants, the relevant scale will be administered as a pre-test. Once the mobile application usage process is complete, the same scale will be repeated as a post-test in the third month of the application.
2 secondary outcomes
Mobile Application Usability Scale
Time frame: The Mobile Application Usability Scale will be used for both expert and patient evaluations. Outcome 1 (Experts): At baseline Outcome 2 (Patients): At Month 3
DISCERN (Quality Criteria for Consumer Health Information)
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared to protect participant confidentiality. Due to the sensitive nature of the health data collected via the digital health application, our ethical board approval restricts data access solely to the primary research team.
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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.
Rabia Bayrambey, 1 principal investigator
Kafkas University
Yeliz Akkuş, 2 study director
Nigde Omer Halisdemir 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 Mobile application in people with Hypertension and Mobile Application, run by Kafkas 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 8 inclusion and 4 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: opening soon, as of the sponsor's last update on 18 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rabia Bayrambey, 1 (+905059809499, rabia_byrmby36@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic Information Form (time frame: At baseline). The study lists 4 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 18 Jun 2026.