Assessment of Depression Levels in Elderly Patients With an Orthopedic Fracture Compared to Patients After a Stroke.

Depression is common among elderly patients hospitalized due to acute conditions like strokes or osteoporotic fractures. It has significant impacts on quality of life, hospitalization rates, and mortality. Although studies have explored depression and its assessment, most focus on non-geriatric or ambulatory populations. This study examined depressive symptoms in elderly patients after a stroke or fracture. We assessed all patients for depression symptoms using the validated Geriatric Depression Scale - 15 item (GDS-15) and searched for contributing factors in each condition.

Study Overview

• Status: Active, not recruiting
• Conditions: Depression; Stroke; Fractures, Bone; Old Age; Debility
• Intervention / Treatment: Diagnostic test: Geriatric Depression Scale - 15

Detailed Description

Depression is a common condition among elderly patients hospitalized due to acute events and has both short-term and long-term prognostic impacts, including reduced quality of life, recurrent hospitalizations, and even mortality. Numerous studies have examined the effects of depression and the ability to assess it, but most have been conducted in non-geriatric populations and in ambulatory patients. It remains unclear whether different acute conditions are associated with distinct risk factors for depressive symptoms and whether depressive symptoms may have varying impacts across different acute conditions. In this study, we examined depressive symptoms in two groups of elderly patients-those with stroke and those with osteoporotic fractures. These are two common acute conditions in the geriatric population, both with significant implications for patient function and the incidence of depression.

Patients were recruited from a large geriatric hospital; all patients were capable of signing consent forms. At the beginning of their hospitalization, all patients will undergo a standardized depression screening test (GDS-15), and additional data will be collected from computerized medical records, including baseline data and the Functional Independence Measure (FIM) at the beginning and end of rehabilitation. Statistical analyses, including univariate analyses and multivariate regression, will be conducted to identify variables associated with depressive symptoms. Linear regression models will be constructed for each group based on the variables significantly associated with depression to assess the risk of depression according to the identified risk factors. To evaluate the risk of depression according to the models and assess the predicted GDS value's ability to classify participants with or without depression ROC curves will be used and AUC will be calculated.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Be'er Ya'aqov, Israel, 70300
    • Shmuel Harofe Geriatric Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age > 65 and hospitalization after stroke or fracture

Exclusion Criteria:

• Prior diagnosis of depression/current antidepressant treatment before hospitalization/ significant cognitive decline as indicated by a Mini-Mental State Examination (MMSE) score below 20/lacking the capacity to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Post stroke patients	Diagnostic test: Geriatric Depression Scale - 15; a validated screening tool designed to identify depression in older adults. It consists of 15 simple yes/no questions that assess depressive symptoms.
Other: Post orthopedic fracture	Diagnostic test: Geriatric Depression Scale - 15; a validated screening tool designed to identify depression in older adults. It consists of 15 simple yes/no questions that assess depressive symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression symptoms prevalence assessed by the Geriatric Depression Scale-15	Depression symptoms prevalence during hospitalization of patients after stroke or orthopedic fractures.	on recruitment and during hospitalization (avarege of about 14 days)

Collaborators and Investigators

• Sponsor: Shmuel Harofeh Hospital, Geriatric Medical Center
• Investigators: Principal Investigator: Yochai Levy, Tel Aviv University, Israel

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2022
• Primary Completion (Estimated): November 13, 2024
• Study Completion (Estimated): November 13, 2024

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 22, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mood Disorders; Wounds and Injuries; Stroke; Depression; Depressive Disorder; Frailty; Fractures, Bone
• Other Study ID Numbers: SH-101-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No