Stroll Safe Outdoor Fall Prevention Program

October 31, 2022 updated by: New York University

The purpose of the study is to examine the feasibility of the program and data collection protocol to plan a multisite clinical trial. The program, "Stroll Safe", an outdoor fall prevention program, will take place in the lab space of the New York University occupational therapy department and in the surrounding neighborhood.

Twenty-four people who meet the inclusion criteria will be enrolled after informed consent. Recruitment will include follow up with people who expressed interest in the fall prevention program during a survey study conducted by the PI, and interested members of community-based programs for seniors who have agreed to be community partners for this study. Twelve participants will be assigned to the 7-week program and 12 will receive written information on outdoor fall prevention (control group).

The topics addressed in the once a week, 7-week outdoor falls prevention program, for which a treatment manual has been developed, are based on the results of a survey conducted of community dwelling older adults that identified gaps in knowledge and use of prevention strategies, and the related literature. The program includes pre-set modules, however, participants will be able to voice individual concerns and problem-solve solutions during group discussions. Using an ecological perspective, the Health Belief Model, and problem solving theory as a guide, the intervention will include a didactic component, group problem solving, practical application of strategies, and self-advocacy regarding reporting problems to the city.

Analysis will primarily focus on process measures.Post-intervention, semi-structures interviews will be conducted and analyzed to assess strengths/limitations of the program and participant's attribution of any behavioral changes to the intervention. Although statistical significant is not anticipated in this small feasibility study, repeated measures ANOVA will be used to examine changes in Falls Efficacy Scale-International (FES-I), Outdoor Falls Questionnaire (OFQ) and Falls Behavioral Scale for the Older Person (FaB) scores from pre to post-test for the treatment and control groups. Effect sizes (Cohen's d) will also be calculated. Change in number of stumbles, trips, slips, and falls before and after the program will also be analyzed.

Data will be collected on falls self-efficacy and strategy use at study enrollment (Baseline), after completion of the 7 week program (1st Post-test), and at 2 months post-program completion (2nd Post-test). Participants will be asked to keep daily diaries of stumbles, trips, slips, and falls from the time they enroll in the study until two months following the completion of the program.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10003
        • New York University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 55 years of age or older
  • English speaking
  • Cognitively competent (i.e. a Montreal Cognitive Impairment (MOCA) score >24)
  • Able to ambulate outdoors independently with or without an assistive device
  • Able to travel independently to the program site
  • Have sustained a stumble, trip, slip or fall outdoors within the last year

Exclusion Criteria:

  • Younger than age 55
  • Living in an institutional setting
  • Non-English speaker
  • Requiring assistance for outdoor ambulation and/or community mobility
  • Cognitively impaired as per MOCA scores
  • An active medical, neurological or psychiatric disease that interferes with participation (e.g. stroke, chronic obstructive pulmonary disease requiring supplemental oxygen, Amyotrophic Lateral Sclerosis, and schizophrenia).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
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.
Behavioral: Stroll Safe outdoor fall prevention program
The structure of the program will model the evidenced-based Lifestyle Re-Design program (Clark et al., 2012). Session 1, 2, 4 & 5 will include a brief didactic presentation about outdoor fall risks and strategy use from the group leader. This will be followed by group discussion/problem solving related to addressing risks. Identified strategies will be recorded on a wipe board and transcribed for group members in order to create handouts. Each 90 minute session will end with action planning, where participants will write down behavioral changes they will implement in the coming week. Session 3 and 6, also 90 minutes, will include outdoor mobility training and practice using strategies discussed in previous sessions. Training sessions will be led by the PI and an assistant. The final session will be a review of risks, strategy use, and reinforcement of behavioral changes in participant's action plans.
Active Comparator: Control
Participants in the control group will receive written information about preventing outdoor falls.
Behavioral: Outdoor fall prevention brochure
The control group participants will be given a written brochure on tips for preventing outdoor falls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Outdoor Falls Questionnaire (OFQ)
Time Frame: Baseline, following 7-week program, 2 months post program completion
Baseline, following 7-week program, 2 months post program completion
Change in Falls Behavioral Scale for the Older Person (FaB)
Time Frame: Baseline, following 7-week program, 2 months post program completion
Baseline, following 7-week program, 2 months post program completion
Change in Falls Self-efficacy Scale- International (FES-I)
Time Frame: Baseline, following 7-week program, 2 months post program completion
Baseline, following 7-week program, 2 months post program completion

Other Outcome Measures

Outcome Measure
Time Frame
Change in Fall diary reports
Time Frame: At baseline, every two weeks until 2 months post program completion
At baseline, every two weeks until 2 months post program completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

October 24, 2016

First Submitted That Met QC Criteria

October 25, 2016

First Posted (Estimate)

October 27, 2016

Study Record Updates

Last Update Posted (Actual)

November 3, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

September 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • NewYorkU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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