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

ConditionHypertension
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Gaziantep

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Intervention Group - Mobile App-Supported Follow-UpExperimental treatment 1 intervention
Group B: Control Group - Standard Follow-UpNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, Month 3 (3 months)
2

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.

Time frame
Baseline and Month 3

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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