Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Impact of An Emergency Response System on Anxiety and Health-Care Use

This study has been completed.
Sponsor:
Collaborators:
The Physicians' Services Incorporated Foundation
Lifeline
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00330720
First received: May 26, 2006
Last updated: NA
Last verified: September 2004
History: No changes posted
  Purpose

What to do after an elderly patient falls but is not seriously injured can be a very challenging decisions for the patient and the Emergency Physician. Unfortunately, homecare support is often unavailable for weeks. The patient and physician must then choose between discharge home without support, or hospitalization. An emergency response service (ERS) allows the patient to summon assistance from anywhere in their home, and may provide another option.

Objectives: To see how an ERS affects patients’ anxiety, fear of falling, and use of the health-care system after discharge. We will study patients over 70 years of age who have fallen but do not need to be hospitalized. Our belief is that the ERS will improve patient anxiety, and may prevent return visits to the Emergency or episodes of prolonged immobilization after a fall.

Methods: Patients agreeing to participate in the study will be assigned by chance to receive either current standard discharge care, or standard care plus the use of the emergency response system. Patients will be interviewed one month after discharge to compare the impact of the ERS. This study is a first step in deciding whether the ERS is a useful new technology.


Condition Intervention
Anxiety
Falls
Fear of Falling
Device: Emergency Response System (Device)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial To Asses The Impact of An Emergency Response System on Anxiety and Health-Care Use Among Older Emergency Patients After A Fall

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Anxiety measured with the Hospital Anxiety and Depression Scale, at 1 month

Secondary Outcome Measures:
  • Fear of Falling, using Falls Efficacy Scale at 1 month
  • Proportion who Returned to the Emergency Department by 2 months
  • Proportion who are Hospitalized by 2 months
  • Length of Stay by 2 months, in Days.

Estimated Enrollment: 80
Study Start Date: November 2002
Estimated Study Completion Date: June 2004
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age greater than or equal to 70 years.
  2. Primary complaint of a fall and discharged home directly from the Emergency Department -

Exclusion Criteria:

  1. Admitted to hospital
  2. Not independently living
  3. No Phone Line
  4. Unable to give informed consent
  5. Living outside geographic catchment area -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00330720

Locations
Canada, Ontario
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4S 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
The Physicians' Services Incorporated Foundation
Lifeline
Investigators
Principal Investigator: Jacques S. Lee, MD Sunnybrook Health Sciences Center
  More Information

Publications:
Dibner A. Personal emergency response systems: comunication technology aids eldery and their family. J Appl Gerontol. 1990;9:504-510.

ClinicalTrials.gov Identifier: NCT00330720     History of Changes
Other Study ID Numbers: 205-2002, PSIF Grant #02-13
Study First Received: May 26, 2006
Last Updated: May 26, 2006
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
Personal Emergency Response System
Anxiety
Fear of Falling
RCT

Additional relevant MeSH terms:
Anxiety Disorders
Emergencies
Disease Attributes
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014