- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05600504
Development and Validation of a Prediction Model for Depression and Anxiety in Perioperative Elderly Adults
A Prediction Model for Early Prediction of Depression and Anxiety in Perioperative Elderly Adults
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Beijing
-
Beijing, Beijing, China
- Chinese PLA General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Geriatric surgical patients ≥65 years old
• non-selective cardiac surgery
Exclusion Criteria:
Missing or incomplete patient follow-up records
- ASA classification Ⅳand V
- Delirium before surgery
- Patient refused to enroll
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Elderly patients over the age of 65
no intervention
|
no intervention
|
Elderly patients over the age of 65 undergoing elective non-cardiac surgery
no intervention
|
no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression
Time Frame: Depression within 7 days of surgery
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety
Time Frame: Anxiety within 7 days of surgery
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: WEIDONG MI, PhD, Chinese PLA General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PLAGH-DA-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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