DepressionNCT06570356
Assessment of Depression Levels in Elderly Patients With an Orthopedic Fracture Compared to Patients After a Stroke.
A study testing Geriatric Depression Scale - 15 in people with Depression and Old Age; Debility, run by Shmuel Harofeh Hospital, Geriatric Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Old Age; Debility, Stroke
- What is being tested?
- Geriatric Depression Scale - 15
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteIsrael
- Study dates
- 2 Feb 2022to 13 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age > 65 and hospitalization after stroke or fracture
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Depression, Old Age; Debility, Stroke, Fractures, Bone
- Being tested
- Geriatric Depression Scale - 15
- Medical subject headings
- Depression, Frailty, Stroke, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric Depression Scale - 15Diagnostic test
a validated screening tool designed to identify depression in older adults. It consists of 15 simple yes/no questions that assess depressive symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Post stroke patients | Other | Not described Receives: Diagnostic Test: Geriatric Depression Scale - 15 |
| Post orthopedic fracture | Other | Not described Receives: Diagnostic Test: Geriatric Depression Scale - 15 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression symptoms prevalence assessed by the Geriatric Depression Scale-15
Depression symptoms prevalence during hospitalization of patients after stroke or orthopedic fractures.
Measured: on recruitment and during hospitalization (avarege of about 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start2 Feb 2022
- Primary completion13 Nov 2024 (estimated)
- Study completion13 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shmuel Harofeh Hospital, Geriatric Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yochai Levy, Shmuel Harofeh Hospital, Geriatric Medical Center
- Investigators
- Yochai Levy, Principal investigator, Tel Aviv University, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06570356
- Sponsor's protocol ID
- SH-101-22
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Depression Levels in Elderly Patients With an Orthopedic Fracture Compared to Patients After a Stroke.
- ClinicalTrials.gov ID
- NCT06570356
- Acronym / sponsor ID
- SH-101-22
- Conditions
- Depression, Old Age; Debility, Stroke, Fractures, Bone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shmuel Harofeh Hospital, Geriatric Medical CenterOther government
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 13 Nov 2024 (estimated)
- Study completion
- 13 Nov 2024 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post stroke patients | Other | Diagnostic Test: Geriatric Depression Scale - 15 |
| Post orthopedic fracture | Other | Diagnostic Test: Geriatric Depression Scale - 15 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Age > 65 and hospitalization after stroke or fracture
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geriatric Depression Scale - 15a validated screening tool designed to identify depression in older adults. It consists of 15 simple yes/no questions that assess depressive symptoms. | Diagnostic test | Post orthopedic fracture, Post stroke patients |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yochai Levy principal investigator
Tel Aviv University, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geriatric Depression Scale - 15 in people with Depression and Old Age; Debility, run by Shmuel Harofeh Hospital, Geriatric Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression symptoms prevalence assessed by the Geriatric Depression Scale-15 (time frame: on recruitment and during hospitalization (avarege of about 14 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.