NCT06570356

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2022

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 26, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2024

Completed
Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

2.8 years

First QC Date

August 20, 2024

Last Update Submit

August 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

Post stroke patients

OTHER
Diagnostic Test: Geriatric Depression Scale - 15

Post orthopedic fracture

OTHER
Diagnostic Test: Geriatric Depression Scale - 15

Interventions

a validated screening tool designed to identify depression in older adults. It consists of 15 simple yes/no questions that assess depressive symptoms.

Post orthopedic fracturePost stroke patients

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age \> 65 and hospitalization after stroke or fracture

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shmuel Harofe Geriatric Medical Center

Be’er Ya‘aqov, 70300, Israel

Location

MeSH Terms

Conditions

DepressionFrailtyStrokeFractures, Bone

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesWounds and Injuries

Study Officials

  • Yochai Levy

    Tel Aviv University, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director

Study Record Dates

First Submitted

August 20, 2024

First Posted

August 26, 2024

Study Start

February 2, 2022

Primary Completion

November 13, 2024

Study Completion

November 13, 2024

Last Updated

August 26, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations