Effect of Digital Intervention on Self-management of Hypertensive Patients at High Risk of Stroke

Not Applicable

Not yet recruiting

• Conditions: Hypertension; Mhealth

• Registration Number: NCT07089810
• Lead Sponsor: Affiliated Hospital of Nantong University

Brief Summary

Stroke is the second leading cause of death in the world, and the number of stroke patients in China ranks the first in the world. Hypertension is the most important risk factor. Studies have shown that 80% of stroke can be prevented by controlling risk factors. However, the management level of hypertension patients in China is still low, and their self-management ability is insufficient.

Digital health management, such as remote monitoring, AI and mobile health platforms, provides a new way for hypertension prevention and control. Foreign studies have shown that digital interventions can effectively improve patients' self-management behaviors, such as diet, exercise and blood pressure control. Interventions based on wechat, APP and other tools in China have also achieved positive results, but face challenges such as patient acceptance, system adaptation and data continuity.

Based on behavior change wheel (BCW) theory \*\* and digital platform, this study formulated personalized intervention programs for hypertension patients in high-risk groups of stroke, and promoted health behavior change from three aspects of \*\* ability, motivation and opportunity \*\*. By improving disease cognition and strengthening self-management, the incidence of stroke can be ultimately reduced, and a new strategy for hypertension prevention and control in the community can be provided.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-07-22
• Study First Submitted QC: 2025-07-22
• Last Update Submitted: 2025-07-22
• Study First Posted: 2025-07-28
• Last Update Posted: 2025-07-28
• Study Start: 2025-08-01
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hypertension Self-Management Behavior Rating Scale (HPSMBRS)	From the beginning of enrollment to the end 6 months later
Hypertension Knowledge Scale (HK-LS)	From the beginning of enrollment to the end 6 months later
Stroke premonitory symptom alertness assessment questionnaire	From the beginning of enrollment to the end 6 months later
Self-rating Depression Scale (PHQ-9)	From the beginning of enrollment to the end 6 months later
Generalized Anxiety Disorder-7 (GAD-7)	From the beginning of enrollment to the end 6 months later

Secondary Outcome Measures

Name	Time	Method
Blood Pressure (mmHg)	From the beginning of enrollment to the end 6 months later
Blood lipid (mmol/L)	From the beginning of enrollment to the end 6 months later
Fasting blood glucose (mmol/L)	From the beginning of enrollment to the end 6 months later
Glycosylated hemoglobin (HbA1c)(%)	From the beginning of enrollment to the end 6 months later
Blood homocysteine (Hcy) (mmol/L)	From the beginning of enrollment to the end 6 months later
Is the risk of stroke reduced? : Risk prediction for atherosclerotic cardiovascular disease in China Prediction for ASCVD Risk in China, China-PAR	From the beginning of enrollment to the end 6 months later