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Active, Not Recruiting

NCT Number: NCT06570356

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shmuel Harofe Geriatric Medical Center

Be’er Ya‘aqov, 70300, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Geriatric Depression Scale - 15

Diagnostic Test

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

Primary outcomes

  1. Depression symptoms prevalence assessed by the Geriatric Depression Scale-15

    Time frame: on recruitment and during hospitalization (avarege of about 14 days)

    Depression symptoms prevalence during hospitalization of patients after stroke or orthopedic fractures.

Sponsors and collaborators

Lead sponsor

Shmuel Harofeh Hospital, Geriatric Medical Center

Other Gov

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 26, 2024
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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