Data Driven Behavior Intervention and Medical Outcome Evaluation of Patients' Comprehensive Monitoring

Obesity Clinical Trial

Official title:

Data Driven Behavior Intervention and Medical Outcome Evaluation of Patients' Comprehensive Monitoring

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04966754
• Other study ID #: JS-2898
• Status: Not yet recruiting
• Start date: August 1, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: July 2021
• Source: Peking Union Medical College Hospital
• Contact: Huadong Zhu, MD
• Phone: 13910696435
• Email: huadongzhu[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

During the study, the resuscitation room, general wards and ICU were installed fixed or mobile acquisition devices in the resuscitation room, the emergency department of Peking Union Medical College Hospital, and the collection platform was set up. Patients with acute diseases (infection, diabetes complications, etc.) caused by metabolic syndrome (obesity, diabetes, etc.) were selected after informed consent. All medical intervention behaviors, relevant medical records and medical outcome records within the collection scope of the device platform were collected prospectively . And regular follow-up, guidance of patients with metabolic syndrome control, while collecting all the lifestyle characteristics of patients, some patients with metabolic cabin research, and observe the relevant medical outcomes. After that, all the collected data were coded, and the influence of all lifestyle and medical behavior interventions on patients' medical outcomes was studied by artificial intelligence method.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diabetes and / or obesity (BMI>=28).
• Emergency room / emergency ward / EICU;
• Be able to understand and agree the research protocol and sign the informed consent

Exclusion Criteria:

• Pregnant women / lactation period;
• The estimated survival time was less than 1 year;
• Long term follow-up is not guaranteed;
• Failure to comply with the protocol or procedure;
• The collection of medical behavior data can not complete the de privacy or label after de privacy;
• Other researchers think that it is not suitable for inclusion

Related Conditions & MeSH terms

• Diabetes
• Infection
• Metabolic Complication
• Metabolic Disturbance
• Metabolic Syndrome
• Obesity

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Guangdong Provincial People's Hospital, Guangzhou Huyun Hospital Management Co., Ltd, Peking University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of metabolic complications	Relapse of acute metabolic disease, stability of biochemical metabolic indexes (such as glycosylated hemoglobin, BMI)	6 weeks
Primary	Complication control	The occurrence of metabolic complications, infection and cardiovascular events	3 weeks
Primary	Rate of mortality	30-day and 90-day mortality. Death due to cardiovascualr complications	6 months
Secondary	Total cost of treatment	Length of stay, length of stay in ICU, ventilator usage time	3 weeks
Secondary	Quality of life	Dynamic monitoring of quality of life through quality-of-life evaluation chart	6 months