Construction of a Comprehensive Health Management Platform for Patients With Cardiovascular-Kidney-Metabolic Syndrome

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking University Third Hospital

About this trial

Cardiovascular-Kidney-Metabolic (CKM) syndrome underscores the pathophysiologic interplay among metabolic risk factors, chronic kidney disease (CKD) and the cardiovascular system. This crosstalk precipitates multi-organ dysfunction, increases adverse cardiovascular events, and imposes heavy familial and socioeconomic burdens. Building a health-management platform within research wards is therefore urgent. Such a platform is the pivotal venue for assessment, monitoring, intervention and follow-up in continuous care.

Leveraging the existing health-management system of the Health Screening Center at Peking University Third Hospital, the investigators will develop a comprehensive CKM platform that integrates systemic inflammatory biomarkers, cardiovascular early-warning algorithms, and personalized diet-and-exercise prescriptions. The system will provide cyclic management encompassing evaluation, guidance, monitoring, feedback and longitudinal follow-up.

A randomized controlled trial with two-year prospective follow-up will enroll patients at CKM stages 0-2 to evaluate clinical improvement, quality of life, dietary behavior and physical activity after platform enrollment. The project will enable early identification of high-risk individuals, deliver precision management, maximize data utility, and offer a novel research-ward model that addresses mobile-health pain points and closes the CKM care loop.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

CKM stage 0-2 as defined by the American Heart Association CKM diagnostic guidelines

Age 18-75 years

Able to use a smartphone and wearable activity tracker

Willing to sign informed consent and attend scheduled follow-up visits

Disqualifiers

CKM stage 3-4

Acute or critically ill conditions requiring hospitalization

Malignant tumors or any active cancer under treatment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Comprehensive Health Management Platform

    Behavioral

    The health-management programme comprises: * Screening: collection of demographic data, medical and personal history, physical examination (blood pressure, heart rate, etc.), laboratory tests (inflammatory markers, lipids, glucose, renal and liver function), exercise habits, nutritional status, body-composition analysis, and physical-fitness tests (reaction time, grip strength, vertical jump, one-leg stance with eyes closed, back strength, sit-and-reach, 1-min sit-ups, 1-min push-ups, cardiopulmonary exercise test). * Assessment: CKM risk stratification based on the above. ③ Intervention: individualised exercise, dietary and pharmacological prescriptions. * Follow-up: ongoing monitoring of clinical indices, exercise, diet and medication adherence by a physician-health-manager team.

  • Post-examination follow-up management

    Other intervention

    Post-examination report interpretation service and telephone follow-up for patients with abnormal findings.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Experimental ArmExperimental treatment 1 intervention
Group B: Control ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Height

Body height measured in centimeters using a height and weight measuring instrument. Reported as mean value at each assessment time point.

Time frame
Baseline, Month 12, Month 24
2

Weight

Body weight measured in kilograms using a height and weight measuring instrument. Reported as mean value at each assessment time point.

Time frame
Baseline, Month 12, Month 24
3

Systolic Blood Pressure

Systolic blood pressure measured in millimeters of mercury (mmHg) using an automated sphygmomanometer after 5 minutes of rest. Reported as mean value at each assessment time point.

Time frame
Baseline, Month 12, Month 24
4

Diastolic Blood Pressure

Diastolic blood pressure measured in millimeters of mercury (mmHg) using an automated sphygmomanometer after 5 minutes of rest. Reported as mean value at each assessment time point.

Time frame
Baseline, Month 12, Month 24

Secondary outcomes

1

White Blood Cell Count

White blood cell count measured in 10\^9 cells per liter (10\^9/L) using automated hematology analyzer. Reported as mean value at each assessment time point.

Time frame
Baseline, Month 12, Month 24
2

Red Blood Cell Count

Red blood cell count measured in 10\^12 cells per liter (10\^12/L) using automated hematology analyzer. Reported as mean value at each assessment time point.

Time frame
Baseline, Month 12, Month 24
3

Hemoglobin Concentration

Hemoglobin concentration measured in grams per liter (g/L) using cyanmethemoglobin method. Reported as mean value and number of participants with values below lower limit of normal (LLN) at each assessment time point.

Time frame
Baseline, Month 12, Month 24
4

Platelet Count

Platelet count measured in 10\^9 cells per liter (10\^9/L) using automated hematology analyzer. Reported as mean value at each assessment time point.

Time frame
Baseline, Month 12, Month 24

Other outcomes

1

Score on International Physical Activity Questionnaire-Short Form (IPAQ-SF)

Physical activity level assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF), a 7-item self-administered questionnaire measuring the frequency and duration of vigorous-intensity activity, moderate-intensity activity, and walking during the past 7 days. Total physical activity is calculated as metabolic equivalent of task (MET)-minutes per week, categorized as low (\<600 MET-min/week), moderate (600-3000 MET-min/week), or high (\>3000 MET-min/week) activity level. Higher MET-minutes indicate higher physical activity level. Reported as mean total MET-minutes per week and number of participants in each activity category at each assessment time point.

Time frame
Baseline, Month 12, Month 24
2

Score on 36-Item Short Form Health Survey (SF-36)

Health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36), a 36-item self-administered questionnaire measuring eight health domains: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH). Each domain score ranges from 0 to 100, with higher scores indicating better health status. Two summary component scores are calculated: Physical Component Summary (PCS) and Mental Component Summary (MCS). Reported as mean scores for each domain and summary components at each assessment time point.

Time frame
Baseline, Month 12, Month 24

Locations

This trial has no locations.

Sponsors and contacts

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