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

NCT05600504 | Completed

• 1 other identifier: PLAGH-DA-001
• Study Type: observational
• Target: 6,386
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Predictive Model

Keywords

predicted model; depression; anxiety; elderly patient

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Anxiety

  Anxiety within 7 days of surgery

Study Arms (2)

No depression

no intervention

Other: no intervention

Depression

no intervention

Other: no intervention

Interventions

no intervention OTHER

no intervention

Depression; No depression

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elderly patients, aged 65 years and above, who underwent elective non-cardiac surgeries in China during the period spanning from April 1, 2020, to April 30, 2022.

You may qualify if:

• elective non-cardiac surgery,
• American society of Aneshesiologists (ASA) classification Ⅰ \~ Ⅲ,
• patients over age 65.

You may not qualify if:

• patient refused follow-up study,
• missing data exceeding 20%,
• went to ICU or died after surgery,
• have a history of any mental disorders such as epilepsy, Parkinson's disease, depression, anxiety, sleep disorders, or are currently taking relevant intervention drugs 5) patients with severe deafness, dementia or speech impairment.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Peking University First Hospital: collaborator
• Peking University People's Hospital: collaborator
• Shanghai Zhongshan Hospital: collaborator
• Fudan University: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator
• The Affiliated Hospital Of Guizhou Medical University: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Taihe Hospital: collaborator
• Capital Medical University: collaborator
• Beijing Tiantan Hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• China-Japan Friendship Hospital: collaborator
• Sun Yat-sen University: collaborator

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Weidong Mi, PhD

  Chinese PLA General Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director (Cheif expert of National key research and development program of China 2018YFC2001900)

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: October 31, 2022
• Study Start: April 1, 2020
• Primary Completion: October 31, 2021
• Study Completion: April 30, 2022
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

CN (1)