DepressionNCT00717041
Epidemiology of Depression, Anxiety, and Cognitive Impairment
An observational study of Depression and Anxiety, run by University of Rochester at 1 site in United States.
Trial summary
Many older adults have undetected health problems and lack basic prevention measures. Failure to identify and treat these conditions can lead to unnecessary morbidity and mortality and a decreased quality of life. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression, Anxiety, Cognitive Impairment
- How many people
- 1,206 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Feb 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All older adults arriving at participating hospital emergency departments to obtain emergency care.
Who may be able to join
- Age 60 and older
- Arrival at ED
Who cannot join
- Institutionalized
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiology of Depression, Anxiety, and Cognitive Impairment Among Emergency Department Patients
Many older adults have undetected health problems and lack basic prevention measures. Failure to identify and treat these conditions can lead to unnecessary morbidity and mortality and a decreased quality of life. Traditional screening and intervention programs, usually based in primary care providers' offices, have been insufficient, particularly in medically underserved populations. Alternate sites for screening and intervention have begun to receive attention and may hold promise.
The emergency department (ED) is the entry point for access to medical and social services for many patients and has the potential to serve as a site to identify older adults with unmet needs. However, we do not know the prevalence of depression and cognitive impairment and how they differ by mode of arrival of the patient to the ED. Second, a question remains as to the validity of screening patients during an acute illness. Upon completion, this study will describe the epidemiology of the population of older adults presenting to the ED.
Read the detailed description
Many older adults have undetected health problems and lack basic prevention measures. Failure to identify and treat these conditions can lead to unnecessary morbidity and mortality and a decreased quality of life. Traditional screening and intervention programs, usually based in primary care providers' offices, have been insufficient, particularly in medically underserved populations. Alternate sites for screening and intervention have begun to receive attention and may hold promise.
The emergency department (ED) is the entry point for access to medical and social services for many patients and has the potential to serve as a site to identify older adults with unmet needs. However, we do not know the prevalence of depression and cognitive impairment and how they differ by mode of arrival of the patient to the ED. Second, a question remains as to the validity of screening patients during an acute illness. This study aims to:
- Compare the prevalence of depression and cognitive impairment among patients who arrive at the ED by EMS, as compared to those arriving via other means.
- Evaluate the reliability of screening patients for depression and cognitive impairment during an acute illness and after the illness.
- To evaluate correlates of depression, anxiety and suicidal ideation. Upon completion, this study will describe the epidemiology of the population of older adults presenting to the ED.
- Conditions
- Depression, Anxiety, Cognitive Impairment
- Keywords
- Depression, Anxiety, Cognitive Impairment, Emergency medicine, prehospital care
- Medical subject headings
- Depression, Anxiety Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Presenting to the ED | Patients who present to the ED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With Depression by Patient Health Questionnaire - 9
Number of participants with depression as measured by the Patient Health Questionnaire - 9, with a score of greater than or equal to 10.
Measured: 2 hours
Participants With Cognitive Impairment by Six Item Screener
Number of participants with cogintiive impairment as measured by the Six Item Screener, with greater than 2 questions incorrect
Measured: 2 hours
Participants With Anxiety by Generalized Anxiety Disorder - 7
Participants with anxiety as measured by the Generalized Anxiety Disorder - 7, with a score greater than or equal to 10.
Measured: 2 hours
Secondary outcomes (1)
Depression and Cognitive Impairment at 2 Weeks
For the individuals who are able to be contacted in 2 weeks, how many still test positive for depression and cognitive impairment.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startMay 2008
- Primary completionSep 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,206 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Manish Shah, University of Rochester
- Investigators
- Manish N. Shah, MD MPH, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717041
- Sponsor's protocol ID
- RSRB 24085
- Other IDs
- NIH 5K23AG028942
- Status last verified
- Jun 2015
- First submitted
- 14 Jul 2008
- Last updated
- 15 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Depression, Anxiety, and Cognitive Impairment Among Emergency Department Patients
- ClinicalTrials.gov ID
- NCT00717041
- Acronym / sponsor ID
- RSRB 24085
- Conditions
- Depression, Anxiety, Cognitive Impairment
- Keywords
- Depression, Anxiety, Cognitive Impairment, Emergency medicine, prehospital care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,206 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- May 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 16 Jul 2008 (estimated)
- Results
- Posted 15 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many older adults have undetected health problems and lack basic prevention measures. Failure to identify and treat these conditions can lead to unnecessary morbidity and mortality and a decreased quality of life. Traditional screening and intervention programs, usually based in primary care providers' offices, have been insufficient, particularly in medically underserved populations. Alternate sites for screening and intervention have begun to receive attention and may hold promise.
The emergency department (ED) is the entry point for access to medical and social services for many patients and has the potential to serve as a site to identify older adults with unmet needs. However, we do not know the prevalence of depression and cognitive impairment and how they differ by mode of arrival of the patient to the ED. Second, a question remains as to the validity of screening patients during an acute illness. Upon completion, this study will describe the epidemiology of the population of older adults presenting to the ED.
Detailed description
Many older adults have undetected health problems and lack basic prevention measures. Failure to identify and treat these conditions can lead to unnecessary morbidity and mortality and a decreased quality of life. Traditional screening and intervention programs, usually based in primary care providers' offices, have been insufficient, particularly in medically underserved populations. Alternate sites for screening and intervention have begun to receive attention and may hold promise.
The emergency department (ED) is the entry point for access to medical and social services for many patients and has the potential to serve as a site to identify older adults with unmet needs. However, we do not know the prevalence of depression and cognitive impairment and how they differ by mode of arrival of the patient to the ED. Second, a question remains as to the validity of screening patients during an acute illness. This study aims to:
- Compare the prevalence of depression and cognitive impairment among patients who arrive at the ED by EMS, as compared to those arriving via other means.
- Evaluate the reliability of screening patients for depression and cognitive impairment during an acute illness and after the illness.
- To evaluate correlates of depression, anxiety and suicidal ideation. Upon completion, this study will describe the epidemiology of the population of older adults presenting to the ED.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Presenting to the ED | – | –Patients who present to the ED |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All older adults arriving at participating hospital emergency departments to obtain emergency care.
Key inclusion criteria (2 listed)
- Age 60 and older
- Arrival at ED
Key exclusion criteria (1 listed)
- Institutionalized
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Participants With Depression by Patient Health Questionnaire - 9
Time frame: 2 hours
Number of participants with depression as measured by the Patient Health Questionnaire - 9, with a score of greater than or equal to 10.
Participants With Cognitive Impairment by Six Item Screener
Time frame: 2 hours
Number of participants with cogintiive impairment as measured by the Six Item Screener, with greater than 2 questions incorrect
Participants With Anxiety by Generalized Anxiety Disorder - 7
Time frame: 2 hours
Participants with anxiety as measured by the Generalized Anxiety Disorder - 7, with a score greater than or equal to 10.
1 secondary outcome
Depression and Cognitive Impairment at 2 Weeks
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Manish N. Shah, MD MPH principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Anxiety, run by University of Rochester at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 15 Jun 2015. 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 United States. 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?
Yes. Results are posted in the registry (first posted 15 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Participants With Depression by Patient Health Questionnaire - 9 (time frame: 2 hours). The study lists 3 primary outcomes in all. 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 15 Jun 2015.