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NCT Number: NCT07089810

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases mHealth

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(1) hypertensive patients at high risk of stroke screened in the National Screening and Intervention Project for High-risk Population of Stroke (2) willing to participate Cooperate and sign the informed consent form

Exclusion criteria

(1) TIA and stroke patients (2) severe cognitive impairment (MMSE≤9) and (3) inability to use smartphones (4) Refusal to participate

Treatment and study plan

Digital intervention has a high blood pressure in the high-risk population of stroke Study on the effect of stress on self-management behavior of patients

Device

Intervention group (n = 60) : Interventions were developed for five behavioral problems, as follows:

  • Lack of knowledge about hypertension
  • Measures: APP push knowledge (risk factors, medication, lifestyle, etc.), blood pressure monitoring teaching, monthly online lectures, regular feedback and encouragement of blood pressure data.
  • Poor medication compliance
  • Measures: Medication reminders were set by the APP, and repeated and recorded when no medication was taken.
  • Obesity/overweight Targets: BMI 18.5-23.9, waist circumference <90cm in men and <85cm in women Interventions: promoting knowledge about the dangers of obesity, daily exercise reminders, setting weight loss goals and encouraging weight loss.
  • A high-sodium diet Target: <6g salt per day
  • Measures: Release of low-salt dietary guidelines (graphic and text) and distribution of salt-limiting spoons (1-2 grams).
  • Drinking too much Target: ≤25g alcohol per day for men and ≤15g for women; Weekly male ≤140g, female ≤80

Primary outcomes

  1. Hypertension Self-Management Behavior Rating Scale (HPSMBRS)

    Time frame: From the beginning of enrollment to the end 6 months later

  2. Hypertension Knowledge Scale (HK-LS)

    Time frame: From the beginning of enrollment to the end 6 months later

  3. Stroke premonitory symptom alertness assessment questionnaire

    Time frame: From the beginning of enrollment to the end 6 months later

  4. Self-rating Depression Scale (PHQ-9)

    Time frame: From the beginning of enrollment to the end 6 months later

  5. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: From the beginning of enrollment to the end 6 months later

Secondary outcomes

  1. Blood Pressure (mmHg)

    Time frame: From the beginning of enrollment to the end 6 months later

  2. Blood lipid (mmol/L)

    Time frame: From the beginning of enrollment to the end 6 months later

  3. Fasting blood glucose (mmol/L)

    Time frame: From the beginning of enrollment to the end 6 months later

  4. Glycosylated hemoglobin (HbA1c)(%)

    Time frame: From the beginning of enrollment to the end 6 months later

  5. Blood homocysteine (Hcy) (mmol/L)

    Time frame: From the beginning of enrollment to the end 6 months later

  6. Is the risk of stroke reduced? : Risk prediction for atherosclerotic cardiovascular disease in China Prediction for ASCVD Risk in China, China-PAR

    Time frame: From the beginning of enrollment to the end 6 months later

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Nantong University

Other

Registry information

Official study title

Digital Intervention Based on BCW Theory Has a High Blood Pressure in High-risk Population of Stroke Study on the Effect of Stress on Self-management Behavior of Patients

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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