Kafkas University
Kars, 36000, Turkey (Türkiye)
NCT Number: NCT07556419
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.
Trial opening soon.
Get Notified18 year–85 year
All sexes
Interventional
Not applicable
Kars, 36000, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The mobile application will be developed for patients with hypertension. It will include educational videos, educational texts, and reminders.
The control group will not be interfered with.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Rabia Bayrambey, 1
CONTACT
Yeliz Akkuş, 2
CONTACT
Kafkas University
Other
The Effect of a Mobile Application Developed for Hypertension Patients on Blood Pressure Control, Treatment Adherence, and Self-Efficacy: A Randomized Controlled Trial
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