Developing a Mobile App for Patients With Hypertension

NCT07556419 | Not Yet Recruiting

• 1 other identifier: 80576354-050-99/886
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Mobile Application Usability Scale

  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)

  At baseline

Study Arms (2)

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.

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.

Behavioral: control group

Interventions

Mobile application BEHAVIORAL

The mobile application will be developed for patients with hypertension. It will include educational videos, educational texts, and reminders.

Mobile Application Group

control group BEHAVIORAL

The control group will not be interfered with.

Control Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kafkas University: lead

Study Sites (1)

Kafkas University

Kars, 36000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension; Treatment Adherence and Compliance

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Rabia B Bayrambey, 1

  Kafkas University

  PRINCIPAL INVESTIGATOR

• Yeliz A Akkuş, 2

  Nigde Omer Halisdemir University

  STUDY DIRECTOR

Central Study Contacts

Rabia B Bayrambey, 1

CONTACT

+905059809499; rabia_byrmby36@outlook.com

Yeliz A Akkuş, 2

CONTACT

+905052598458; yelizakkus@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, participant and practitioner blinding will not be possible. To reduce blinding bias, outcome measurements will be administered by an evaluator unaware of group assignments, data analysis will be conducted blindly with groups coded as "Group 1/Group 2", and all participants will be contacted with similar frequency.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: 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.

Study Record Dates

• First Submitted: March 28, 2026
• First Posted: April 29, 2026
• Study Start (Estimated): June 2, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 20, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)