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Completed

NCT Number: NCT03624777

Efficacy of the Stroll Safe Outdoor Fall Prevention Program

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.

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Key information

Conditions

Accidental Fall Healthy Aging Injury Prevention

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

1199 Norc, New York, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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?

Treatment and study plan

Outdoor Fall prevention brochure

Behavioral

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

Stroll Safe outdoor fall prevention program

Behavioral

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

New York University

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Aug 10, 2018
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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