Generative AI-Supported Personalized Education Compared With Printed Material for Adults With Hypertension (GenAI-HYPER)

August 18, 2026 updated by: Akdeniz University

The Effect of Generative Artificial Intelligence-Supported Personalized Education Compared With Printed Material on Hypertension Knowledge and Medication Adherence in Adults With Hypertension

This study evaluates whether generative artificial intelligence-supported personalized education can improve hypertension knowledge and medication adherence in adults with hypertension compared with standard printed educational material. A total of 88 adults with hypertension are included in the study. Participants are assigned to either an intervention group or a control group. The control group receives a printed hypertension education booklet. The intervention group receives personalized educational content prepared using generative artificial intelligence based on individual characteristics and needs, together with weekly WhatsApp or SMS messages, voice messages, and brief telephone follow-up. The intervention lasts four weeks, and final assessments are performed in the fifth week. Hypertension knowledge, medication adherence self-efficacy, and blood pressure are assessed before and after the intervention. It is expected that personalized education will improve hypertension knowledge and medication adherence compared with printed education.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Antalya
      • Antalya, Antalya, Turkey (Türkiye), 07070
        • Akdeniz University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Voluntary agreement to participate in the study
  • Diagnosis of hypertension
  • Use of antihypertensive medication for at least 6 months
  • Medication adherence self-efficacy score of 26 or lower
  • Age 18 years or older
  • Ability to read and write in Turkish
  • General health status adequate for communication
  • Ability to read SMS messages and use WhatsApp

Exclusion Criteria:

  • Withdrawal from the study after enrollment
  • Inability to be reached by telephone during the follow-up period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: control group
Participants in this arm receive standard hypertension education and a printed hypertension education booklet. Baseline assessments and blood pressure measurements are performed in the first week. In the fifth week, post-intervention assessments and blood pressure measurements are repeated.
Behavioral: Standard Hypertension Education
Participants receive standard hypertension education including medication-related information and a printed hypertension education booklet developed based on expert recommendations.
Experimental: intervention group
Participants in this arm receive generative artificial intelligence-supported personalized hypertension education based on their individual characteristics, needs, baseline information, and the standardized hypertension education content. The intervention is delivered over four weeks through weekly WhatsApp or SMS messages and voice messages. Brief structured telephone follow-up is conducted during the first and fourth weeks. In the fifth week, post-intervention assessments and blood pressure measurements are performed.
Behavioral: Generative AI-Supported Personalized Hypertension Education
Participants receive personalized hypertension education generated using generative artificial intelligence based on individual characteristics, needs, baseline information, and standardized hypertension education content. The intervention is delivered over four weeks through weekly WhatsApp or SMS messages and voice messages. Brief structured telephone follow-up is provided in the first and fourth weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in Medication Adherence Self-Efficacy Scale-Short Form (MASES-SF) Total Score at Week 5
Time Frame: Baseline and Week 5
Medication adherence self-efficacy will be assessed using the 13-item Medication Adherence Self-Efficacy Scale-Short Form (MASES-SF). Each item is scored from 1 (not at all sure) to 4 (very sure), resulting in a total score ranging from 13 to 52. Higher scores indicate greater self-efficacy for adhering to antihypertensive medication. The change in total score from baseline to Week 5 will be evaluated.
Baseline and Week 5
Mean Change From Baseline in Hypertension Knowledge-Level Scale (HK-LS) Total Score at Week 5
Time Frame: Baseline and Week 5
Hypertension knowledge will be assessed using the 22-item Hypertension Knowledge-Level Scale (HK-LS). The scale includes six domains: definition, medical treatment, medication adherence, lifestyle, diet, and complications. Responses are recorded as true, false, or do not know, and each correct response receives 1 point. Higher scores indicate greater hypertension knowledge, and a score of 16 or above indicates a high level of hypertension knowledge. The change in total score from baseline to Week 5 will be evaluated.
Baseline and Week 5

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in Systolic Blood Pressure at Week 5
Time Frame: Baseline and Week 5
Systolic blood pressure will be measured in mmHg at baseline and Week 5. The change in systolic blood pressure from baseline to Week 5 will be evaluated.
Baseline and Week 5
Mean Change From Baseline in Diastolic Blood Pressure at Week 5
Time Frame: Baseline and Week 5
Diastolic blood pressure will be measured in mmHg at baseline and Week 5. The change in diastolic blood pressure from baseline to Week 5 will be evaluated.
Baseline and Week 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Akdeniz University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yasemin DEMİR AVCI, PhD, Akdeniz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AKDENIZU-TBAEK-711

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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