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Efficacy of the Stroll Safe Outdoor Fall Prevention Program

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ClinicalTrials.gov Identifier: NCT03624777
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : July 7, 2021
Sponsor:
Information provided by (Responsible Party):
New York University

Brief Summary:
This study examines the effectiveness of the Stroll Safe Outdoor Fall Prevention program, a 7-week group based educational intervention. Half of participants are assigned to the Stroll Safe program and half are assigned to a wait list control group that initially receives written information only on outdoor falls prevention.

Condition or disease Intervention/treatment Phase
Accidental Fall Injury Prevention Healthy Aging Behavioral: Outdoor Fall prevention brochure Behavioral: Stroll Safe outdoor fall prevention program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy of the Stroll Safe Outdoor Fall Prevention Program
Actual Study Start Date : January 14, 2019
Estimated Primary Completion Date : August 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

Arm Intervention/treatment
Experimental: Stroll Safe Program Behavioral: Stroll Safe outdoor fall prevention program
Participants in the treatment group will attend a once a week 7-week outdoor fall prevention program that includes didactic presentations, group discussions/ problem solving, practice in strategy use, and action planning for safe community mobility.

Active Comparator: Outdoor Fall Prevention Brochure Behavioral: Outdoor Fall prevention brochure
Participants in the wait list control group will initially receive written information only about preventing outdoor falls




Primary Outcome Measures :
  1. Change in Outdoor Falls Questionnaire (Subscale score for strategy use) [ Time Frame: Baseline, following 7-week program, 2 months post program completion ]
    Measures use of outdoor fall prevention strategies. Range 0-36 with a higher score indicating greater use of fall prevention strategies.

  2. Change in Falls Behavioral Scale for the Older Person (24 item version) [ Time Frame: Baseline, following 7-week program, 2 months post program completion ]
    Measures awareness of and practice of behaviors to protect against falling. Mean score is calculated. Range 1-4, with a higher score indicating safest behaviors.


Secondary Outcome Measures :
  1. Change in Falls Self-Efficacy Scale-International [ Time Frame: Baseline, following 7-week program, 2 months post program completion ]
    Measures level of concern about falling. Range 16-64, with a higher score indicating a greater level of concern.

  2. Change in fall diary reports [ Time Frame: Baseline, every two weeks until 2 months post program completion ]
    Participants keep track of trips, slips, and falls on a calendar. Range 0-no limit. Higher number indicates more slips, trips and falls during the two week look back period.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Community-dwelling adults age 60 years or older, English speaking, cognitively competent (i.e. have a Montreal Cognitive Impairment score (MOCA) >24), and able to walk outdoors independently with or without a mobility device. In addition, they must answer "yes" to one or more of the following questions: Have you fallen outdoors and hurt yourself in the past year?, Have you fallen outdoors 2 or more times in the past year?, Are you afraid that you might fall outdoors?, Have you had 2 or more stumbles, trips, or slips outdoors in the past month?

Exclusion Criteria:

Less than 60 years of age, living in an institutional setting (e.g. nursing home), non-English speaker, Montreal Cognitive Assessment Score <24, requiring the assistance of another person to walk outdoors, non-ambulatory, an acute health condition that would interfere with participation(e.g. recent fracture, uncontrolled/poorly managed mental health condition, respiratory disease requiring supplemental oxygen), they reply "no" to all of the following questions: Have you fallen outdoors and hurt yourself in the past year?, Have you fallen outdoors 2 or more times in the past year?, Are you afraid that you might fall outdoors?, Have you had 2 or more stumbles, trips, or slips outdoors in the past month?


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): NCT03624777


Contacts
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Contact: Tracy Chippendale, PhD, OTR/L 212-998-9012 tlc223@nyu.edu

Locations
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United States, New York
1199 Norc Recruiting
New York, New York, United States, 10029
Contact: Nicole Thomas, MSW         
Warbasse Cares NORC Recruiting
New York, New York, United States, 11235
Contact: Karin A Stieber, MSW         
Rochdale Village NORC Recruiting
New York, New York, United States, 11434
Contact: Marie-Cendy Theophile, MSW         
Sponsors and Collaborators
New York University
Investigators
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Principal Investigator: Tracy Chippendale, PhD, OTR/L New York University
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Responsible Party: New York University
ClinicalTrials.gov Identifier: NCT03624777    
Other Study ID Numbers: Stroll Safe
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No