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Trial record 1 of 1 for:    NCT02392013
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Home Hazard Removal Program to Reduce Falls (HARP)

This study is currently recruiting participants.
Verified December 2015 by Susan Stark, Washington University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT02392013
First Posted: March 18, 2015
Last Update Posted: December 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
US Department of Housing and Urban Development
Information provided by (Responsible Party):
Susan Stark, Washington University School of Medicine
  Purpose
This study evaluates the effectiveness and implementation of a home-hazard removal program to reduce falls in older adults through a community program delivered through the aging services network. The investigators will conduct a hybrid effectiveness/implementation trial of 300 older adults at risk for a fall who will be randomized to a home-hazard removal program or usual care and then followed for 12 months.

Condition Intervention
Accidental Falls Other: Home Modification

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Removing Home Hazards for Older Adults

Resource links provided by NLM:


Further study details as provided by Susan Stark, Washington University School of Medicine:

Primary Outcome Measures:
  • Number of falls [ Time Frame: 12 months ]
    Prospective daily reporting of falls using a calendar


Secondary Outcome Measures:
  • Daily activity performance. [ Time Frame: 12 months ]
    Participant daily activity performance will be measured by the Older Americans Resources and Services (OARS) ADL Scale

  • Fall self-efficacy. [ Time Frame: 12 months ]
    Participant self-efficacy in performing daily activities without falling will be measured by the Falls Efficacy Scale-International (FES-I).

  • Health-related quality of life. [ Time Frame: 12 months ]
    Participant self-reported health will be measured using the SF-36.


Estimated Enrollment: 300
Study Start Date: December 2014
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Home Modification Group
A tailored home-modification (home-hazard removal) intervention delivered in the home by occupational therapists over three visits and with a booster session at six months.
Other: Home Modification
Removal of home barriers or hazards.
No Intervention: Usual Care Group
Usual care by an Area Agency on Aging

Detailed Description:
The investigators will randomly select a sample of older adults from the large observational cohort of older adults assessed annually by an Area Agendy on Aging via the National Aging Program Information System (NAPIS). The eligibility criteria include age 65 years or older and self-report of one previous fall or more in the preceding 12 months or self-report as "worried about falling." We will conduct baseline assessments and randomize participants to receive an home hazard removal program or usual care. Outcomes (falls, fall self-efficacy) will be assessed by a blinded rater at baseline and 12 months after intervention. All assessments and study visits will occur in participants' homes.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Individuals aged 65 years or older and self-report of one previous fall or more in the preceding 12 months or self-report as "worried about falling."

Exclusion Criteria:

  • Individuals residing in nursing homes or individuals with severe cognitive impairment who are unable to give consent to participate (as determined by a score of greater than 10 on the SBT for memory10).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02392013


Contacts
Contact: Susan L Stark, PhD 314-932-1033 starks@wusm.wustl.edu
Contact: Jane W Conte, MEd 314-932-1011 contej@wusm.wustl.edu

Locations
United States, Missouri
Occupational Therapy Program at Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Jane Conte, M Ed    314-932-1011    contej@wusm.wustl.edu   
Contact: Susan L Stark, PhD    314-932-1033    starks@wusm.wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
US Department of Housing and Urban Development
Investigators
Principal Investigator: Susan L Stark, PhD Washington University School of Medicine
  More Information

Responsible Party: Susan Stark, Assisstant Professor of Neurology and Occupational Therapy, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02392013     History of Changes
Other Study ID Numbers: MOHHU0024-14
First Submitted: March 5, 2015
First Posted: March 18, 2015
Last Update Posted: December 14, 2015
Last Verified: December 2015

Keywords provided by Susan Stark, Washington University School of Medicine:
older adult falls
home hazards
home barriers