- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07776834
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
Active, not recruiting
Conditions
Study Type
Interventional
Enrollment (Actual)
88
Phase
- 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
-
-
Antalya
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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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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
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
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
Investigators
- 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)
June 1, 2026
Primary Completion (Estimated)
December 20, 2026
Study Completion (Estimated)
December 20, 2026
Study Registration Dates
First Submitted
August 18, 2026
First Submitted That Met QC Criteria
August 18, 2026
First Posted (Actual)
August 20, 2026
Study Record Updates
Last Update Posted (Actual)
August 20, 2026
Last Update Submitted That Met QC Criteria
August 18, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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.