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Effectiveness of AI-Facilitated Shared Decision-Making for Hypertension Control: A Randomized Controlled Trial

Effectiveness of AI-Facilitated Shared Decision-Making for Hypertension Control: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119344
Enrollment
Unknown
Registered
2026-02-26
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Interventions

AI Management Group:Patients receive 3 consecutive days of AI-facilitated interactive education covering: Medication adherence, Therapeutic lifestyle interventions (diet, exercise), Secondary hyperte
Routine Management Group:Standard hypertension care per physician’s clinical judgment, without AI support.

Sponsors

Department of Cardiology, Huashan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18–65 years, regardless of gender. 2. Newly diagnosed hypertensive patients: initial clinic blood pressure: 140–160/90–100 mmHg, and deemed by investigators to require oral pharmacological treatment (based on the 2025 Chinese Hypertension Guidelines or equivalent standards). 3. Previously diagnosed patients: currently on monotherapy (single antihypertensive agent), hypertension duration =1 year, and follow-up clinic blood pressure: 140–160/90–100 mmHg.

Exclusion criteria

Exclusion criteria: 1.History of atrial fibrillation, myocardial infarction, chronic heart failure, coronary heart disease, stroke, or specific types of cardiomyopathies. 2.Comorbidities involving significant organ damage or chronic wasting diseases (e.g., malignancies). 3.Neurological disorders such as Alzheimer’s disease, Parkinson’s disease, or brain tumors.

Design outcomes

Primary

MeasureTime frame
BP Control Rate: Defined as 24-hour ambulatory BP <130/80 mmHg. Measured at baseline and study end (day 60). ;Shared Decision-Making (SDM) Quality: Assessed using the Option12 Scale.;

Secondary

MeasureTime frame
BP Variability: Calculated from 24-hour ambulatory BP.;Medication Adherence: Evaluated via MMAS-8 scale.;Health-Promoting Behaviors: Measured using the HPLP-II R Scale.;

Countries

China

Contacts

Public ContactLiwenBao

Department of Cardiology, Huashan Hospital

blw_betty@163.com+86 139 1707 3226

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026