Developing a Mobile App for Patients With Hypertension

The Effect of a Mobile Application Developed for Hypertension Patients on Blood Pressure Control, Treatment Adherence, and Self-Efficacy: A Randomized Controlled Trial

This project, based on King's Goal Achievement Theory, aims to develop a mobile application for individuals over 18 years of age diagnosed with hypertension. The project comprises the stages of educational content creation, mobile application design, implementation, and effectiveness evaluation. Within the scope of the project, individuals' 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 medication dosage changes will be excluded from the project scope. No intervention will be made to the currently applied medical treatment during the study; participants' routine clinical follow-up and treatment processes will continue within the framework of standard care. Only education and mobile application-based supportive interventions will be implemented within the scope of the project.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Treatment Adherence; Self-Efficacy; Mobile Application; Blood Pressure Control
• Intervention / Treatment: Behavioral: Mobile application; Behavioral: control group

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. Individuals in the mobile application group will begin using the mobile application, downloaded from Google Play and the App Store, which is structured according to the theoretical components of King's Goal Achievement Theory and designed to bring about behavioral change in hypertensive patients. 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: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rabia B Bayrambey, 1; Phone Number: +905059809499; Email: rabia_byrmby36@outlook.com
• Study Contact Backup: Name: Yeliz A Akkuş, 2; Phone Number: +905052598458; Email: yelizakkus@gmail.com

Study Locations

• Turkey (Türkiye)
  • Kars, Turkey (Türkiye), 36000
    • Kafkas Üniversity
    • Contact: Phone Number: +905059809499; Email: rabia_byrmby36@outlook.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Baseline and Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	At baseline

Collaborators and Investigators

• Sponsor: Kafkas University
• Investigators: Principal Investigator: Rabia B Bayrambey, 1, Kafkas Üniversity; Study Director: Yeliz A Akkuş, 2, Nigde Omer Halisdemir University

Study record dates

Study Major Dates

• Study Start (Estimated): June 2, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 20, 2027

Study Registration Dates

• First Submitted: March 28, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): April 29, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Hypertension; Treatment Adherence; Self-Efficacy; mobile application; blood pressure control; King's Goal Achievement Theory
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Behavior; Health Behavior; Hypertension; Treatment Adherence and Compliance; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID 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