Efficacy of the Stroll Safe Outdoor Fall Prevention Program

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of the Stroll Safe Outdoor Fall Prevention Program

Conditions
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Accidental Fall, Injury Prevention, Healthy Aging

Intervention / Treatment
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* Behavioral: Outdoor Fall prevention brochure
* Behavioral: Stroll Safe outdoor fall prevention program


Participation Criteria
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Eligibility Criteria
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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?

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stroll Safe Program<br> | Behavioral: Stroll Safe outdoor fall prevention program<br>* 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.<br>|
| Active Comparator: Outdoor Fall Prevention Brochure<br> | Behavioral: Outdoor Fall prevention brochure<br>* Participants in the wait list control group will initially receive written information only about preventing outdoor falls<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |