Clinical trial NCT03624777: Efficacy of the Stroll Safe Outdoor Fall Prevention Program
Official title: Efficacy of the Stroll Safe Outdoor Fall Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Fall
Injury Prevention
Healthy Aging
Lead sponsor: New York University
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 110
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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?

Primary outcomes:
measure: Change in Outdoor Falls Questionnaire (Subscale score for strategy use)
timeFrame: Baseline, following 7-week program, 2 months post program completion
measure: Change in Falls Behavioral Scale for the Older Person (24 item version)
timeFrame: Baseline, following 7-week program, 2 months post program completion
Secondary outcomes:
measure: Change in Falls Self-Efficacy Scale-International
timeFrame: Baseline, following 7-week program, 2 months post program completion
measure: Change in fall diary reports
timeFrame: Baseline, every two weeks until 2 months post program completion
Other outcomes:
Locations:
city: New York
country: United States
facility: 1199 Norc
state: New York
city: New York
country: United States
facility: Warbasse Cares NORC
state: New York
city: New York
country: United States
facility: Rochdale Village NORC
state: New York
Study officials:
affiliation: New York University
name: Tracy Chippendale, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References: