Digital Education for Hypertension Management: Effects on Self-Care and Health Literacy (DIGIHYPE-HTN)

Digital Education Approach in Hypertension Management: Its Effect on Self-Care Behaviors and Health Literacy

The goal of this clinical trial is to learn whether a digital education program can help people with high blood pressure (hypertension) manage their condition better. The program aims to improve self-care behaviors and health literacy by teaching participants how to use digital tools, follow healthy lifestyle habits, and take their medicines regularly.

Researchers will compare two groups. One group will receive digital education that includes short videos, brochures, and podcasts about blood pressure control and how to use online health platforms such as e-Nabız (Turkey's national e-health system). The other group will not receive this education. Participants will attend two sessions during two weeks.

The main questions are:

Does digital education improve self-care and e-health literacy in people with hypertension? Does it help participants take their medicine as prescribed and maintain healthy habits such as diet and exercise?

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension; High Blood Pressure
• Intervention / Treatment: Behavioral: Hypertension Self-Management and E-Health Education

Detailed Description

Hypertension is a major cause of premature death worldwide. In recent years, unhealthy lifestyles, obesity, and socioeconomic factors have been identified as the leading causes of hypertension. It affects approximately two-thirds of adults aged 19-79 worldwide. This large number highlights the magnitude of the global burden of chronic disease and the strain on health systems. Furthermore, two-thirds of adults diagnosed with hypertension live in low- and middle-income countries, and it is estimated that a significant proportion of adults are unaware they have the condition. Additionally, many individuals diagnosed with hypertension are under treatment, but only a fraction manage to control their condition effectively through medication.

Given the global prevalence of hypertension, the situation in Turkey is also quite critical. Studies have shown that approximately 30% of the adult population in Turkey has hypertension. These data highlight the need for significant improvements in diagnosis, treatment, and management processes.

Adherence to medication therapy in patients with hypertension is a key determinant in controlling blood pressure and preventing complications. Reliable and valid tools should be used to assess treatment adherence. A review of the current literature reveals numerous studies on hypertension management, medication adherence, and health literacy. These studies have generally examined the impact of digital health interventions on blood pressure control and, in some cases, medication adherence. However, there is a limited number of studies that directly evaluate the impact of a self-care education program-specifically designed for individuals diagnosed with hypertension and focused on enhancing health literacy through multiple digital educational materials such as videos, brochures, and podcasts-on medication adherence. Therefore, there is a need for more comprehensive and holistic research on this topic.

The aim of this study is to evaluate the effect of digital education (using videos, brochures, and podcasts) that supports self-care and health literacy among individuals diagnosed with hypertension on medication adherence. It is expected that the findings will emphasize the importance of digital literacy in hypertension management and guide health education programs. This methodology aims to contribute to the development of effective approaches to enhance self-management, self-efficacy, and e-health literacy through digital hypertension education. Additionally, the findings will be used to assess the impact of digital hypertension management education on its widespread adoption and medication adherence.

Sample Size: The sample size will be determined based on the study's power analysis. Calculations performed considering a 50% effect size, a 95% confidence interval, and a 5% margin of error, indicated that both experimental and control groups should each consist of 88 participants.

Research Hypotheses

The digital education program has a positive effect on increasing self-care scores among patients diagnosed with hypertension.

The digital education program has a positive effect on increasing e-health literacy scores among patients diagnosed with hypertension.

Following the digital education program, positive changes will occur in the health behaviors of patients diagnosed with hypertension (regarding regular medication use, blood pressure monitoring, and healthy eating).

Data Collection Process: Data will be collected through face-to-face interviews after obtaining verbal and written informed consent forms from the participants.

Data Collection Tools:

A Data Collection Form developed by the researchers in accordance with the literature will be used. The form includes the following sections:

Patient Information Form: This section covers sociodemographic variables such as age, gender, marital status, education level, income status, employment status, and family history of hypertension.

Disease-Related Variables: This section includes items on the duration of the disease, number of antihypertensive medications used, regular blood pressure monitoring, and use of digital health tools.

Hypertension Self-Care Profile (HBP SCP): This scale measures self-care behaviors, motivation, and self-efficacy levels in individuals with hypertension. It is a 4-point Likert scale consisting of three subscales: Behavior, Motivation, and Self-Efficacy. Higher scores indicate better self-care, stronger motivation, and greater self-efficacy.

e-Health Literacy Scale: This tool assesses individuals' self-perceived ability to find, evaluate, and use health-related information in online environments. It is a 5-point Likert-type scale consisting of eight items, where higher scores indicate higher e-health literacy.

Hypertension Management and e-Health Literacy Training for Individuals Aged 50 and Older:

The training program is a structured educational initiative designed to improve hypertension management and e-health literacy among individuals aged 50 and older. It provides participants with information on the causes of hypertension, risk factors, self-care behaviors, and digital health services. The goal is to enable individuals to monitor their blood pressure at home, adopt healthy lifestyle behaviors, and use digital health platforms safely.

Data Analysis:

Data will be analyzed using statistical software. The normality of data distribution will be examined through both visual (histograms and probability plots) and analytical (Kolmogorov-Smirnov and Shapiro-Wilk tests) methods. Frequency, percentage, standard deviation, and arithmetic mean values will be used. For normally distributed data, the paired t-test will be applied; for non-normally distributed data, nonparametric methods will be used.

• Study Type: Interventional
• Enrollment (Estimated): 166
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 50 years or older
• Individuals with a clinical diagnosis of hypertension or those regularly using antihypertensive medication
• Individuals actively registered at the Life Center and receiving regular services
• Participants who provide written and verbal informed consent to voluntarily join the study
• Individuals able to fully participate in the designated digital health education sessions
• Participants capable of maintaining consistency throughout the intervention and follow up periods

Exclusion Criteria:

• Individuals without a diagnosis of hypertension
• Individuals unable to complete questionnaires or education sessions due to communication barriers or cognitive limitations
• Illiterate individuals, as data collection requires reading and completing written questionnaires
• Individuals unable to maintain participation or adhere to the follow up schedule during the study period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The group receiving Self-Care & E-Health (SC-EH) Training; The study group consists of individuals aged 50 and older who are registered at the Bartın Life Center and meet the inclusion criteria, including those diagnosed with hypertension or taking antihypertensive medication. They will participate in an intervention program consisting of two sessions focused on hypertension self-management and e-health literacy.	Behavioral: Hypertension Self-Management and E-Health Education; The education program consists of two sessions designed for hypertension management, combining self-care and e-health literacy.Each session is planned to last 15-20 minutes. The first session covers hypertension and healthy lifestyle changes (nutrition, exercise, stress management, etc.).The second session introduces e-health tools (digital blood pressure monitor apps, etc.) and systems like e-Nabız and MHRS, including practical demonstrations.The education is supported by visual-aided video narrations, plain-language brochures, sample screenshots, and live applications. Participants practically demonstrate logging into e-health systems and tracking data using their own mobile devices or provided digital tools. The intervention is conducted twice, once a week for two weeks. At the end of each session, knowledge and application skills are assessed through short evaluation questions. Post-education changes in individuals' hypertension management and e-health literacy levels are measured; Other Names: Integrated Self-Care and E-Health Literacy Training for Hypertension Management
No Intervention: The group not receiving Self-Care & E-Health (SC-EH) Training; The same scales will be administered to the control group without providing any training. Four weeks after the training provided to the experimental group, the control group will be given the training brochure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypertension and E-Health Knowledge Level Score	Change in Hypertension Self-Care Profile - Behavior Subscale score from baseline to 4 weeks post-intervention, with scores ranging from 11 (min) to 44(max), where higher scores indicate better hypertension self-care behavior.; Change in Hypertension Self- Care Profile - Motivation Subscale score from baseline to 4 weeks post-intervention, with scores ranging from 15 (min) to 60(max), where higher scores indicate better hypertension self-care motivation; Change in Hypertension Self Care Profile - Self Efficacy Subscale score from baseline to 4 weeks post-intervention, with scores ranging from 12 (min) to 48(max), where higher scores indicate better hypertension self-efficacy	Week 1 (end of first session) and Week 4 (end of second session).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
E-Health System Proficiency Task Score	Change in e-Health Literacy Scale score from baseline to 4 weeks post-intervention, with scores ranging from 8 (min) to 40 (max), where higher scores indicate better e-Health Literacy.	Week 1 (end of first session) and Week 4 (end of second session).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure Control (Systolic and Diastolic)	The primary outcome of the study is the mean change in systolic and diastolic blood pressure (mmHg) from baseline (initial session) to the 4-week follow-up. Among hypertensive participants aged 50 and over, a statistically significant reduction in blood pressure levels between these two time points will be considered a clinical indicator that successful self-care performance has been achieved.	Week 1 (end of first session) and Week 4 (end of second session).

Collaborators and Investigators

• Sponsor: Bartın Unıversity

Study record dates

Study Major Dates

• Study Start (Estimated): April 11, 2026
• Primary Completion (Estimated): April 17, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 28, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Hypertension; Medication adherence; Health literacy; Self-care behaviors; Digital education; e-Health literacy
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Hypertension; Medication Adherence
• Other Study ID Numbers: DIGIHYPE-HTN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No