Diabetes Mellitus, Hyperlipidemia, Hypertension, Post Coronary Artery Bypass Grafting, Post PCI
Conditions
Keywords
smartphone, AI-assisted, CABG 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-CABG (coronary artery bypass grafting) patients or post-PCI (percutaneous coronary intervention) patients. A randomized controlled trial design will be used, involving approximately 5-10 hospitals and 536 participants. Eligible participants are adults aged 18 or older, post-CABG or post-PCI patients with hypertension, diabetes, and dyslipidemia.
Interventions
BEHAVIORALSmart family doctor
Based on health managers, participants were additionally 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. The research team will provide participants with one smart band, requiring them to wear the band daily to collect health data during the 6-month study period.
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
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 or post-PCI patients. This system leverages knowledge from coronary artery disease (CAD) secondary prevention guidelines, expert consensus, and a knowledge base addressing common post-CABG 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 No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years. * History of CABG surgery or PCI with history of 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 * Use of a smartphone. * 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.
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 |
|---|---|---|
| Smoking Rate | 6-month | The proportion of patients who have smoked within the past month. |
| 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. |
| 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. |
| Small dense LDL-C | 6-month | Small dense LDL-C analyzed at central lab. |
| Lipoprotein (a) | 6-month | Lipoprotein (a) analyzed at central lab. |
| Fasting blood glucose | 6-month | Fasting blood glucose analyzed at central lab. |
| HbA1c | 6-month | HbA1c levels analyzed at central lab. |
| Physical Activity Level | 6-month | Assessed using the International Physical Activity Questionnaire (IPAQ) and decribed as total MET of walking, moderate, or high intensity physical activity. |
| Quality of life using the Short Form Health Survey (SF-12v2) | 6-month | Quality of life using the Short Form Health Survey (SF-12v2). The higher score indicated the better quality of life. |
| Coronary artery disease-related quality of life | 6-month | Coronary artery disease-related quality of life assessed with the Seattle Angina Questionnaire (SAQ). The higher score indicated the better coronary artery disease-related quality of life. |
| Psychological status | 6-month | Psychological status evaluated using the 9-item Patient Health Questionnaire (PHQ-9). The higher score indicated the worse psychological status |
| Cognitive function | 6-month | Cognitive function assessed with the Mini-Cog test. The higher score indicated the better conginition. |
Other
| Measure | Time frame | Description |
|---|---|---|
| interleukin-6 | 6-month | Interleukin-6 (IL-6) is analyzed at central lab. |
| Interleukin-10 | 6-month | Interleukin-10 (IL-10) is analyzed at central lab. |
| Interleukin-1β (IL-1β) | 6-month | Interleukin-1β (IL-1β) is analyzed at central lab. |
| tumor necrosis factor-α (TNF-α) | 6-month | Tumor necrosis factor-α (TNF-α) is analyzed at central lab. |
| prostaglandin | 6-month | prostaglandin (PG) is analyzed at central lab. |
| Intercellular adhesion molecule-1 | 6-month | Intercellular adhesion molecule-1 (ICAM-1) is analysed at central lab. |
| Von Willebrand factor | 6-month | Von Willebrand factor (vWF) is analyzed at central lab. |
| Urinary albumin-to-creatinine ratio | 6-month | Urinary albumin-to-creatinine ratio is calculated as urine albumin divided by urine creatinine. |
| Urinary sodium excretion rate | 6-month | Urinary sodium excretion rate is analyzed at central lab. |
| BMI | 6-month | Body mass index (BMI) is calculated as weights (kg) divided by the square of heights (meters). |
| Waist circumference | 6-month | Waist circumference is measured at local site. |
| Cost-effectiveness analysis | 6-month | The incremental cost-effectiveness ratio (ICER): the additional cost per patient achieving target control of hypertension, dyslipidemia, or diabetes. |
| C-reactive protein | 6-month | C-reactive protein (CRP) analyzed at central lab. |
| Major adverse cardiovascular events (MACE) | 6-month | The composite endpoint of cardiovascular death, myocardial infarction, stroke, or hospitalization due to cardiovascular disease. |
Countries
China
Contacts
Primary ContactLihua Zhang Zhang, PhD
Outcome results
None listed