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Randomized Controlled Study on Symptom Typing and Internet-Based Individualized Proactive Health Management in Patients with Cardio-Psychological Disorders Based on Portable Electrocardiographic Monitoring

Randomized Controlled Study on Symptom Typing and Internet-Based Individualized Proactive Health Management in Patients with Cardio-Psychological Disorders Based on Portable Electrocardiographic Monitoring

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600129409
Enrollment
Unknown
Registered
2026-08-04
Start date
2026-08-12
Completion date
Unknown
Last updated
2026-08-10

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

Conditions

Cardio-psychological disorders

Interventions

Control group:Routine care (psychological support + exercise education + symptomatic medication)
Intervention group 2:Portable ECG monitoring + active alerting + internet-based medical support + home-based ABC slow rehabilitation three-exercise training (diaphragmatic breathing, standing postures
Intervention group 1:Portable ECG monitoring + active alerting + internet-based medical support

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Age: 18 to 65 years (inclusive); 2.Core symptoms: chief complaint of recurrent (=1 month) cardiac-related symptoms such as palpitations, chest tightness, chest pain, or shortness of breath, with cardiovascular physician ruling out organic heart disease; 3.GAD-7 = 3 or PHQ-9 = 3, and PHQ-15 = 5; 4.Able to understand and voluntarily sign written informed consent;

Exclusion criteria

Exclusion criteria: 1.Definite diagnosis of unstable angina, acute myocardial infarction, or heart failure (NYHA class III or IV); 2.Severe structural heart disease (e.g., moderate-to-severe valvular heart disease, hypertrophic obstructive cardiomyopathy, left ventricular ejection fraction < 50%); 3.Arrhythmias requiring treatment (e.g., persistent or permanent atrial fibrillation, sick sinus syndrome, untreated second-degree type II or higher atrioventricular block); 4.Any unforeseen, clinically significant arrhythmia or myocardial ischemia requiring intervention detected during the 1-week monitoring perio; 5.Uncontrolled hyperthyroidism, severe anemia (hemoglobin < 80 g/L), acute exacerbation of chronic obstructive pulmonary disease, or severe hepatic/renal insufficiency; 6.Severe psychiatric disorders such as schizophrenia, bipolar disorder, substance abuse or dependence, severe anxiety/depression, or current severe suicidal ideation or behavior; 7.Pregnant or breastfeeding women; 8.Inability to use smartphone applications proficiently, or presence of hearing/cognitive impairments affecting study communication and data collection; 9.Concurrent participation in other clinical trials that may interfere with the results of this study; 10.Any other condition judged by the investigator to place the subject at high risk or interfere with study completion;

Design outcomes

Primary

MeasureTime frame
Somatic symptom score (PHQ-15);

Secondary

MeasureTime frame
Depression symptom score (PHQ-9);Anxiety symptom score (GAD-7);Cardiac autonomic reflex tests (CARTs) score;Quality of life score (SF-12);Heart rate variability (HRV);

Countries

China

Contacts

Public ContactDing Rongjing

Peking Union Medical College Hospital

drj2003@vip.163.com+86 135 5254 8612

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026