Diabete Mellitus, Hyperlipidemia, Hypertension, Post CABG, Post PCI
Conditions
Keywords
smartphone, AI-assisted, Revascularization management, metabolic management, Smart family doctor
Brief summary
This study aims to evaluate the effect of an AI-assisted Smart family doctor digital health management tool on improving the control rates of hypertension, diabetes, and dyslipidemia in post-revascularization patients. A randomized controlled trial design will be used, involving approximately 10-20 hospitals and 951 participants. Eligible participants are adults aged between 18 and 80 years, post-CABG or post-PCI patients with hypertension, diabetes, and dyslipidemia.
Interventions
BEHAVIORALSmart family doctor
Participants will be provided Smart family doctor, which is an AI-assisted applications with personalized interactions. The content includes, but is not limited to: (1) General educational content, covering basic health knowledge on diseases, risk factors, and treatment methods; (2) Targeted health information, such as more specific guidance on blood pressure and blood sugar control, medication adherence, exercise, and smoking cessation; (3) Personalized disease management guidance, providing tailored reminders for patients regarding medication, diet, exercise, and medical visits. Patients can also directly report their latest self-measured blood pressure, blood lipid, blood sugar levels, and medication adherence to receive treatment and medication guidance from the 'Smart family doctor'.
BEHAVIORALHealth manager
Participants will received 3-hour health management guidance from a health manager once a week, including guidance on healthy lifestyle, medication treatment, and rehabilitation advice.
BEHAVIORALUsual Care
Participants will receive usual secondary prevention management.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Data manager and statistician.
Intervention model description
The intervention in this study is the implementation of the 'Smart family doctor' system, a digital health management tool designed to support secondary prevention in post-CABG patients. This system leverages knowledge from coronary artery disease (CAD) secondary prevention guidelines, expert consensus, and a knowledge base addressing common post-revascularization issues. It is powered by a large-scale, medical knowledge-enhanced conversational model, enabling personalized interactions with patients to guide their recovery and lifestyle management following surgery.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-80 years. * Underwent CABG or PCI more than 3 months prior and have concurrent hypertension, diabetes, and dyslipidemia. * At least one of the following criteria is meet: * Systolic blood pressure no less than 130 mmHg or diastolic blood pressure no less than 80 mmHg * HbA1c no less than 7% * LDL-C no less than 1.4 mmol/L * Signed informed consent.
Exclusion criteria
* History of heart failure or severe arrhythmias. * Presence of other severe underlying conditions such as cancer or liver and kidney insufficiency. * Pregnancy, lactation, or plans for pregnancy within the next year. * Cognitive, communication impairments, or limitations in daily activities. * Unable to use smartphone.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The control rates of hypertension, diabetes and hyperlipidemia | 6-month | All cretria are meet: 1) Systolic blood pressure less than 130 mmHg and diastolic blood pressure less than 80 mmHg. 2) HbA1c less than 7%. 3) LDL-C less than 1.4 mmol/L. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood glucose Control Rate | 6-month | The proportion of patients with HbA1c less than 7%. |
| Blood Pressure Control Rate | 6-month | The proportion of patients with systolic blood pressure less than 130 mmHg and diastolic blood pressure less than 80 mmHg. |
| Blood lipid Control Rate | 6-month | The proportion of patients with LDL-C less than 1.4mmol/L. |
| Systolic blood pressure | 6-month | Systolic blood pressure measured at the local site. |
| Diastolic blood pressure | 6-month | Diastolic blood pressure measured at the local site. |
| Fasting blood glucose | 6-month | Fasting blood glucose analyzed at central lab. |
| HbA1c | 6-month | HbA1c analyzed at central lab. |
| Total cholesterol | 6-month | Total cholesterol analyzed at central lab. |
| LDL-C | 6-month | LDL-C analyzed at central lab. |
| HDL-C | 6-month | HDL-C analyzed at central lab. |
| Triglycerides | 6-month | Triglycerides analyzed at central lab. |
| Medication adherence (4-item Morisky Medication-Taking Adherence Scale) | 6-month | Medication adherence measured by MMAS-4. The score range from 0 to 4. The higher score indicated the better medication adherence. |
| Coronary artery disease-related quality of life (the Seattle Angina Questionnaire) | 6-month | Coronary artery disease-related quality of life assessed with the Seattle Angina Questionnaire (SAQ). The score range from 0 to 100. The higher score indicated the better coronary artery disease-related quality of life. |
| Smoking Rate | 6-month | The proportion of patients who have smoked within the past month. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Waist circumference | 6-month | Waist circumference is measured at local site. |
| Rehospitalization rate | 6-month | The proportion of patients who had hospitalization |
| The number of emergency visit | 6-month | The number of emergency visit during follow-up period |
| System usability (system usability scale) | 6-month | System usability measured by system usability scale. The proportion of patients who scaled system usability more than 68 points. |
| Subgroup-age | 6-month | Primary outcome analyses in age subgroups: \<=65, \>65 years |
| Subgroup-sex | 6-month | Primary outcome analyses in sex subgroups: women, men |
| Subgroup-education level | 6-month | Primary outcome analyses in education level subgroups: less than high school, high school or higher |
| Subgroup-smoking status | 6-month | Primary outcome analyses in smoking status subgroups: current smoking, no smoking |
| Subgroup-baseline BP level | 6-month | Primary outcome analyses in baseline BP level subgroups: SBP/DBP\>=130/80 mmHg, \<130/80 mmHg |
| Subgroup-baseline LDL-C level | 6-month | Primary outcome analyses in baseline LDL-C level subgroups: \<1.4 mmolL, \>=1.4 mmol/L |
| Subgroup-baseline HbA1c level | 6-month | Primary outcome analyses in baseline HbA1c level subgroups: \<7%, \>=7% |
| BMI | 6-month | Body mass index (BMI) is calculated as weights (kg) divided by the square of heights (meters). |
| Major adverse cardiovascular events (MACE) | 6-month | The composite endpoint of cardiovascular death, myocardial infarction, stroke, or hospitalization due to cardiovascular disease. |
Contacts
Primary ContactLihua Zhang, PhD
Outcome results
None listed