Development of a Mobile Application Called TansiyoRitim for Hypertension Patients

June 16, 2026 updated by: Rabia BAYRAMBEY, Kafkas University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mobile Application Group
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.
Behavioral: Mobile application
The mobile application will be developed for patients with hypertension. It will include educational videos, educational texts, and reminders.
Experimental: Control Group
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.
Behavioral: control group
The control group will not be interfered with.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At baseline
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.
From baseline to Month 3
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.
Baseline and Month 3
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.
Baseline and Month 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kafkas University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rabia Bayrambey, 1, Kafkas University
  • Study Director: Yeliz Akkuş, 2, Nigde Omer Halisdemir University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 20, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 80576354-050-99/886

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings