Development and Validation of a Prediction Model for Depression and Anxiety in Perioperative Elderly Adults

Predictive Model Clinical Trial

Official title:

A Prediction Model for Early Prediction of Depression and Anxiety in Perioperative Elderly Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05600504
• Other study ID #: PLAGH-DA-001
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: February 2024
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Anxiety and depression in later life are highly prevalent, often appear as comorbid disorders, and have many adverse consequences for both the individual and society. Given the disease burden, the large influx of new cases, and the economic costs, efforts should be made to prevent the onset of anxiety and depression in later life. Preventive interventions are likely to become more cost effective when they are targeted at elderly who have been exposed to risk factors known to be predictive of the onset of anxiety and/or depression. As the population aging is speeding up, senile diseases have become a significant and severe public health problem, influencing national health. More than 20 million elderly patients undergo surgery each year in China, accounting for a quarter of the population who undergo surgery. Therefore, it is necessary to construct a predictive model of anxiety and depression in perioperative elderly hospitalized patients

Description:

More than 20 million elderly patients undergo surgery each year in China, accounting for a quarter of the population who undergo surgery. Therefore, it is necessary to construct a predictive model of anxiety and depression in perioperative elderly hospitalized patients. In 2015, the WHO introduced the concept of "healthy ageing" for global ageing, with a focus on the mental health of older people at its core. Previous studies have found a 31 percent risk of anxiety and 29 percent risk of depression in older perioperative patients. Therefore, optimizing perioperative mental health management in older patients remains one of the challenges facing clinicians.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7400
• Est. completion date: April 30, 2022
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Geriatric surgical patients =65 years old
• non-selective cardiac surgery

Exclusion Criteria:

• Missing or incomplete patient follow-up records
• ASA classification ?and V
• Delirium before surgery
• Patient refused to enroll

Related Conditions & MeSH terms

• Depression
• Predictive Model

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (18)

Lead Sponsor

Collaborator

Chinese PLA General Hospital

Beijing Anzhen Hospital, Beijing Tsinghua Changgeng Hospital, Central South University, China-Japan Friendship Hospital, First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital of Xinjiang Medical University, Fudan University, Peking University First Hospital, Peking University People's Hospital, Sun Yat-sen University, Taihe Hospital, The Affiliated Hospital Of Guizhou Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Wuhan Union Hospital, China, Xiangya Hospital of Central South University, Zhejiang Provincial People's Hospital, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression	Primary outcomes were depression Patient Health Questionnaire 9 (PHQ-9).The PHQ-9 is a nine-item questionnaire for screening on the presence of depressive symptoms and monitoring depression severity. Items were scored on a four-point scale with total scores ranging from zero to twenty-seven. Scores were defined as: =5 mild, =10 moderate, and =15 severe level of depression. The recommended screening cutoff was =10, corresponding with at least a moderate level of depression. The higher the score, the worse the situation. The total score ranges from 0 to 27, and higher scores indicate more depressive symptoms.	Depression within 7 days of surgery
Secondary	Anxiety	The GAD-7 is a seven-item questionnaire for screening on the presence of generalized anxiety disorder and assessing its severity. Items were scored on a four-point scale with total scores ranging from zero to twenty-one. Scores were defined as: =5 mild, =10 moderate, and =15 severe anxiety. The recommended screening cutoff was =10, corresponding with at least a moderate level of anxiety. Higher scores mean more anxiety.	Anxiety within 7 days of surgery