Efficacy of the Stroll Safe Outdoor Fall Prevention Program

Healthy Aging Clinical Trial

Official title:

Efficacy of the Stroll Safe Outdoor Fall Prevention Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03624777
• Other study ID #: Stroll Safe
• Status: Completed
• Phase: N/A
• Start date: January 14, 2019
• Est. completion date: May 18, 2022

Study information

• Verified date: May 2022
• Source: New York University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 18, 2022
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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?

Related Conditions & MeSH terms

• Accidental Fall
• Healthy Aging
• Injury Prevention

Intervention

Behavioral:
• Outdoor Fall prevention brochure
Participants in the wait list control group will initially receive written information only about preventing outdoor falls
• 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.

Locations

Country	Name	City	State
United States	1199 Norc	New York	New York
United States	Rochdale Village NORC	New York	New York
United States	Warbasse Cares NORC	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Outdoor Falls Questionnaire (Subscale score for strategy use)	Measures use of outdoor fall prevention strategies. Range 0-36 with a higher score indicating greater use of fall prevention strategies.	Baseline, following 7-week program, 2 months post program completion
Primary	Change in Falls Behavioral Scale for the Older Person (24 item version)	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.	Baseline, following 7-week program, 2 months post program completion
Secondary	Change in Falls Self-Efficacy Scale-International	Measures level of concern about falling. Range 16-64, with a higher score indicating a greater level of concern.	Baseline, following 7-week program, 2 months post program completion
Secondary	Change in fall diary reports	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.	Baseline, every two weeks until 2 months post program completion