The Impact of Mobile Application-Supported Monitoring on Treatment Compliance and Success in Lifestyle Changes in Hypertensive Patients

NCT07299266 | Not Yet Recruiting

• 1 other identifier: 2025/140
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Hypertension (HT) is defined as an arterial blood pressure persistently exceeding 140/90 mmHg in repeated measurements. It is a systemic disease characterized by chronically elevated blood pressure, which can lead to severe health complications. Despite advancements in screening, diagnosis, and treatment methods, hypertension remains a leading risk factor for mortality and disability in both developed and developing countries. Globally, approximately 1.3 billion individuals are living with hypertension. It is projected that within the next two decades, hypertension will become the most significant modifiable risk factor for non-communicable diseases. International guidelines recommend ambulatory blood pressure monitoring (ABPM) and/or home blood pressure monitoring (HBPM) for the diagnosis of hypertension. It has been demonstrated that home and/or ambulatory blood pressure measurements provide superior prognostic information regarding target organ damage and cardiovascular risk compared to clinic-based measurements. Nevertheless, both ambulatory and home blood pressure monitoring have several well-known limitations, including patient comfort, sleep disturbance, accessibility, and cost. The use of various mobile technologies has been evaluated in different settings to improve hypertension management in primary care services. Mobile monitoring can lead to significant reductions in blood pressure (BP), decrease all-cause and hypertension-related hospitalizations, lower all-cause mortality and costs, and enhance quality of life. Furthermore, technology-assisted BP self-monitoring interventions have demonstrated superior BP control outcomes when combined with nurse-led mobile support, physician intervention, and medication review. This research, grounded in the integration of digital health technologies into nursing care, aims to enhance treatment adherence and the success of lifestyle modifications in hypertensive patients through mobile application-supported monitoring. Through this approach, the patient-nurse interaction will be strengthened, and self-management skills will be supported via personalized feedback.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in Systolic and Diastolic Blood Pressure at Month 3

  Participants' blood pressure will be measured twice daily (morning and evening) for 3 months. In the intervention group, measurements are automatically transferred to a mobile application via Bluetooth-enabled devices. In the control group, measurements are recorded in the memory of standard digital devices. Results are reported in millimeters of mercury (mmHg). The change in mean blood pressure values between baseline and the end of Month 3 will be analyzed.

  Baseline, Month 3 (3 months)

• Change from Baseline in "Scale for Assessment of Treatment Adherence and Lifestyle Change Success in Hypertensive Individuals" Total Score at Month 3

  Treatment adherence and lifestyle changes will be assessed using the "Scale for Assessment of Treatment Adherence and Lifestyle Change Success in Hypertensive Individuals" (Hipertansif Bireylerin Tedaviye Uyum ve Yaşam Değişikliği Başarısını Değerlendirme Ölçeği) developed by Esirgen (2018). The scale consists of 18 items across 5 sub-dimensions (medical treatment adherence, communication with physician, healthy nutrition, physical activity and weight control, and salt and fast food consumption). The total score ranges from 18 (minimum) to 90 (maximum). Higher scores indicate better treatment adherence and positive lifestyle behaviors; a score of 68 or higher is considered "compliant". The change in the total score between baseline and the end of Month 3 will be analyzed.

  Baseline and Month 3

Study Arms (2)

Intervention Group - Mobile App-Supported Follow-Up

EXPERIMENTAL

Participants in this group will be provided with a Bluetooth-enabled digital blood pressure device and an integrated mobile application. Following the pre-test administration, participants in the intervention group will be provided with a digital blood pressure monitoring device featuring Bluetooth synchronization, and an integrated mobile application will be installed on their smartphones. Blood pressure measurements taken by the participants will be automatically recorded via the mobile application and stored in a digital database. Furthermore, the application will send regular automated reminders and notifications to participants regarding: Medication intake times Physician follow-up appointments Periodic blood pressure measurement times This intervention aims to facilitate technology-supported monitoring and proactive patient management.

Behavioral: Mobile App-Supported Blood Pressure Monitoring

Control Group - Standard Follow-Up

NO INTERVENTION

Participants in the control group will be provided with a standard digital blood pressure monitoring device that does not have Bluetooth capability. These participants will be instructed to perform their blood pressure measurements regularly and to manually record them on the printed follow-up forms provided to them. The control group will not receive the additional technological support offered to the intervention group, such as the mobile application, automatic data recording, and reminder system; instead, the standard follow-up process will be observed.

Interventions

Mobile App-Supported Blood Pressure Monitoring BEHAVIORAL

Participants will be provided with a Bluetooth-enabled digital blood pressure device integrated with a mobile application. The application will automatically record blood pressure measurements and provide automated reminders for medication intake, scheduled blood pressure measurements, and follow-up appointments. This intervention aims to enhance treatment adherence and promote successful lifestyle modifications in patients with hypertension.

Intervention Group - Mobile App-Supported Follow-Up

Eligibility Criteria

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

You may qualify if:

• Diagnosed with hypertension at least 6 months prior.
• Willingness to voluntarily participate in the study.
• Aged 18 years or older.
• Ability to use a smartphone.
• Ability to read and write (literate).

You may not qualify if:

• Patients with other serious cardiovascular diseases (e.g., heart failure, cardiac arrhythmia).
• Inability to use a smartphone (for the intervention group).
• Pregnancy.
• Withdrawal of consent or request to leave the study.
• Presence of any diagnosed psychiatric disorder.

Sponsors & Collaborators

• University of Gaziantep: lead

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Özlem Ovayolu, Prof. Dr.

  https://www.gaziantep.edu.tr/

  STUDY DIRECTOR

Central Study Contacts

Mehmet Ali Bozkurt, PhD Student

CONTACT

+905535680466; mehmetali1903.mab@gmail.com

Özlem Ovayolu, Prof. Dr.

CONTACT

+905462101692; drovayolu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Model Details: This study was planned as a randomized, controlled and experimental study.

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 23, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share