Skip to content

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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07089810
Enrollment
120
Registered
2025-07-28
Start date
2025-08-01
Completion date
2026-01-10
Last updated
2025-07-28

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

Conditions

Hypertension, Mhealth

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.

Interventions

DEVICEDigital 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

Intervention group (n = 60) : Interventions were developed for five behavioral problems, as follows: 1. 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. 2. Poor medication compliance \- Measures: Medication reminders were set by the APP, and repeated and recorded when no medication was taken. 3. 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. 4. 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). 5. Drinking too much Target: ≤25g alcohol per day for men and ≤15g for women; Weekly male ≤140g, female ≤80

Sponsors

Affiliated Hospital of Nantong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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 questionnaireFrom 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

MeasureTime frame
Blood Pressure (mmHg)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-PARFrom 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026