NCT03624777

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

January 14, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2022

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

2.9 years

First QC Date

August 7, 2018

Last Update Submit

May 25, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Change in Falls Self-Efficacy Scale-International

    Baseline, following 7-week program, 2 months post program completion

  • Change in fall diary reports

    Baseline, every two weeks until 2 months post program completion

Study Arms (2)

Stroll Safe Program

EXPERIMENTAL
Behavioral: Stroll Safe outdoor fall prevention program

Outdoor Fall Prevention Brochure

ACTIVE COMPARATOR
Behavioral: Outdoor Fall prevention brochure

Interventions

Participants in the wait list control group will initially receive written information only about preventing outdoor falls

Outdoor Fall Prevention Brochure

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.

Stroll Safe Program

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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?

You may not qualify if:

  • 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?

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

1199 Norc

New York, New York, 10029, United States

Location

Warbasse Cares NORC

New York, New York, 11235, United States

Location

Rochdale Village NORC

New York, New York, 11434, United States

Location

Related Publications (1)

  • Chippendale T, Albert SM, Mahmood A. Efficacy of the Stroll Safe Outdoor Fall Prevention Program: A Randomized Controlled Trial. Gerontologist. 2023 Oct 17;63(9):1556-1565. doi: 10.1093/geront/gnac145.

Study Officials

  • Tracy Chippendale, PhD, OTR/L

    New York University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2018

First Posted

August 10, 2018

Study Start

January 14, 2019

Primary Completion

December 10, 2021

Study Completion

May 18, 2022

Last Updated

May 27, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations