NCT00717041

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
6.4 years until next milestone

Results Posted

Study results publicly available

June 15, 2015

Completed
Last Updated

June 15, 2015

Status Verified

June 1, 2015

Enrollment Period

4 months

First QC Date

July 14, 2008

Results QC Date

May 22, 2015

Last Update Submit

June 12, 2015

Conditions

Keywords

DepressionAnxietyCognitive ImpairmentEmergency medicineprehospital care

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    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.

    2 hours

Secondary Outcomes (1)

  • Depression and Cognitive Impairment at 2 Weeks

    2 weeks

Study Arms (1)

Presenting to the ED

Patients who present to the ED

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All older adults arriving at participating hospital emergency departments to obtain emergency care.

You may qualify if:

  • Age 60 and older
  • Arrival at ED

You may not qualify if:

  • Institutionalized

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14646, United States

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersCognitive Dysfunction

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersCognition DisordersNeurocognitive Disorders

Limitations and Caveats

* Single center, limited generalizability * Large proportion of individuals lost to follow up * ED visit may have heightened symptoms * Validity of instruments in the ED setting is unknown

Results Point of Contact

Title
Manish N. Shah, MD MPH
Organization
University of Rochester

Study Officials

  • Manish N. Shah, MD MPH

    University of Rochester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 14, 2008

First Posted

July 16, 2008

Study Start

May 1, 2008

Primary Completion

September 1, 2008

Study Completion

February 1, 2009

Last Updated

June 15, 2015

Results First Posted

June 15, 2015

Record last verified: 2015-06

Locations