Epidemiology of Depression, Anxiety, and Cognitive Impairment

Sponsor
University of Rochester (Other)
Overall Status
Completed
CT.gov ID
NCT00717041
Collaborator
National Institute on Aging (NIA) (NIH)
1,206
1
9.1
133

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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:

    1. 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.

    2. Evaluate the reliability of screening patients for depression and cognitive impairment during an acute illness and after the illness.

    3. 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

    Study Type:
    Observational
    Actual Enrollment :
    1206 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Epidemiology of Depression, Anxiety, and Cognitive Impairment Among Emergency Department Patients
    Study Start Date :
    May 1, 2008
    Actual Primary Completion Date :
    Sep 1, 2008
    Actual Study Completion Date :
    Feb 1, 2009

    Arms and Interventions

    Arm Intervention/Treatment
    Presenting to the ED

    Patients who present to the ED

    Outcome Measures

    Primary Outcome Measures

    1. Participants With Depression by Patient Health Questionnaire - 9 [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.

    2. Participants With Cognitive Impairment by Six Item Screener [2 hours]

      Number of participants with cogintiive impairment as measured by the Six Item Screener, with greater than 2 questions incorrect

    3. Participants With Anxiety by Generalized Anxiety Disorder - 7 [2 hours]

      Participants with anxiety as measured by the Generalized Anxiety Disorder - 7, with a score greater than or equal to 10.

    Secondary Outcome Measures

    1. Depression and Cognitive Impairment at 2 Weeks [2 weeks]

      For the individuals who are able to be contacted in 2 weeks, how many still test positive for depression and cognitive impairment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age 60 and older

    • Arrival at ED

    Exclusion Criteria:
    • Institutionalized

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Rochester Rochester New York United States 14646

    Sponsors and Collaborators

    • University of Rochester
    • National Institute on Aging (NIA)

    Investigators

    • Principal Investigator: Manish N. Shah, MD MPH, University of Rochester

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Manish Shah, Professor, University of Rochester
    ClinicalTrials.gov Identifier:
    NCT00717041
    Other Study ID Numbers:
    • RSRB 24085
    • NIH 5K23AG028942
    First Posted:
    Jul 16, 2008
    Last Update Posted:
    Jun 15, 2015
    Last Verified:
    Jun 1, 2015
    Keywords provided by Manish Shah, Professor, University of Rochester
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Presenting to the ED
    Arm/Group Description Patients who present to the ED
    Period Title: Overall Study
    STARTED 1206
    COMPLETED 1206
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title Presenting to the ED
    Arm/Group Description Patients who present to the ED
    Overall Participants 1206
    Age (years) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [years]
    71
    Sex: Female, Male (Count of Participants)
    Female
    634
    52.6%
    Male
    572
    47.4%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    9
    0.7%
    Not Hispanic or Latino
    1184
    98.2%
    Unknown or Not Reported
    13
    1.1%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    178
    14.8%
    White
    1000
    82.9%
    More than one race
    0
    0%
    Unknown or Not Reported
    28
    2.3%
    Region of Enrollment (participants) [Number]
    United States
    1206
    100%
    Anxiety (>=10 on GAD7) (participants) [Number]
    Number [participants]
    119
    9.9%
    Depression (>=10 on PHQ9) (participants) [Number]
    Number [participants]
    177
    14.7%
    Cognitive Impairment (>2 on SIS) (participants) [Number]
    Number [participants]
    106
    8.8%

    Outcome Measures

    1. Primary Outcome
    Title Participants With Depression by Patient Health Questionnaire - 9
    Description Number of participants with depression as measured by the Patient Health Questionnaire - 9, with a score of greater than or equal to 10.
    Time Frame 2 hours

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Presenting to the ED
    Arm/Group Description Patients who present to the ED
    Measure Participants 1206
    Number [participants]
    177
    14.7%
    2. Primary Outcome
    Title Participants With Cognitive Impairment by Six Item Screener
    Description Number of participants with cogintiive impairment as measured by the Six Item Screener, with greater than 2 questions incorrect
    Time Frame 2 hours

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Presenting to the ED
    Arm/Group Description Patients who present to the ED
    Measure Participants 1206
    Number [participants]
    106
    8.8%
    3. Primary Outcome
    Title Participants With Anxiety by Generalized Anxiety Disorder - 7
    Description Participants with anxiety as measured by the Generalized Anxiety Disorder - 7, with a score greater than or equal to 10.
    Time Frame 2 hours

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Presenting to the ED
    Arm/Group Description Patients who present to the ED
    Measure Participants 1206
    Number [participants]
    119
    9.9%
    4. Secondary Outcome
    Title Depression and Cognitive Impairment at 2 Weeks
    Description For the individuals who are able to be contacted in 2 weeks, how many still test positive for depression and cognitive impairment.
    Time Frame 2 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Depressed in the ED Cognitively Impaired in the ED
    Arm/Group Description Patients who present to the ED who test positive for depression Patients presenting to the ED who have cognitive impairment
    Measure Participants 803 808
    Number (95% Confidence Interval) [participants]
    27
    2.2%
    5
    NaN

    Adverse Events

    Time Frame While enrolled in the study, 2 weeks
    Adverse Event Reporting Description
    Arm/Group Title Presenting to the ED
    Arm/Group Description Patients who present to the ED
    All Cause Mortality
    Presenting to the ED
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Presenting to the ED
    Affected / at Risk (%) # Events
    Total 0/1206 (0%)
    Other (Not Including Serious) Adverse Events
    Presenting to the ED
    Affected / at Risk (%) # Events
    Total 0/1206 (0%)

    Limitations/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

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Manish N. Shah, MD MPH
    Organization University of Rochester
    Phone 585-275-1198
    Email manish.shah@rochester.edu
    Responsible Party:
    Manish Shah, Professor, University of Rochester
    ClinicalTrials.gov Identifier:
    NCT00717041
    Other Study ID Numbers:
    • RSRB 24085
    • NIH 5K23AG028942
    First Posted:
    Jul 16, 2008
    Last Update Posted:
    Jun 15, 2015
    Last Verified:
    Jun 1, 2015