- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07776834
Generative AI-Supported Personalized Education Compared With Printed Material for Adults With Hypertension (GenAI-HYPER)
18 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
88
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Antalya
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Antalya, Antalya, Turquía (Türkiye), 07070
- Akdeniz University Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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.
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Participants receive standard hypertension education including medication-related information and a printed hypertension education booklet developed based on expert recommendations.
|
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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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean Change From Baseline in Medication Adherence Self-Efficacy Scale-Short Form (MASES-SF) Total Score at Week 5
Periodo de tiempo: 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.
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Baseline and Week 5
|
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Mean Change From Baseline in Hypertension Knowledge-Level Scale (HK-LS) Total Score at Week 5
Periodo de tiempo: 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.
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Baseline and Week 5
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean Change From Baseline in Systolic Blood Pressure at Week 5
Periodo de tiempo: 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.
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Baseline and Week 5
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Mean Change From Baseline in Diastolic Blood Pressure at Week 5
Periodo de tiempo: Baseline and Week 5
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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.
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Baseline and Week 5
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Yasemin DEMİR AVCI, PhD, Akdeniz University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de junio de 2026
Finalización primaria (Estimado)
20 de diciembre de 2026
Finalización del estudio (Estimado)
20 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
18 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
18 de agosto de 2026
Publicado por primera vez (Actual)
20 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
18 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AKDENIZU-TBAEK-711
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .