- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07776834
Generative AI-Supported Personalized Education Compared With Printed Material for Adults With Hypertension (GenAI-HYPER)
18. august 2026 oppdatert av: 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.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
88
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Antalya
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Antalya, Antalya, Tyrkia (Türkiye), 07070
- Akdeniz University Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
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Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean Change From Baseline in Medication Adherence Self-Efficacy Scale-Short Form (MASES-SF) Total Score at Week 5
Tidsramme: 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
Tidsramme: Baseline and Week 5
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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
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Mean Change From Baseline in Systolic Blood Pressure at Week 5
Tidsramme: Baseline and Week 5
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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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Yasemin DEMİR AVCI, PhD, Akdeniz University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juni 2026
Primær fullføring (Antatt)
20. desember 2026
Studiet fullført (Antatt)
20. desember 2026
Datoer for studieregistrering
Først innsendt
18. august 2026
Først innsendt som oppfylte QC-kriteriene
18. august 2026
Først lagt ut (Faktiske)
20. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AKDENIZU-TBAEK-711
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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