Accidental FallNCT03624777
Efficacy of the Stroll Safe Outdoor Fall Prevention Program
A study testing Outdoor Fall prevention brochure and Stroll Safe outdoor fall prevention program in people with Accidental Fall and Injury Prevention, run by New York University at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Fall, Injury Prevention, Healthy Aging
- What is being tested?
- Outdoor Fall prevention brochure and Stroll Safe outdoor fall prevention program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Jan 2019to 18 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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?
Who cannot join
- 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?
Trial locations and contacts
3 sites in 1 country.
United States3 sites
1199 Norc
New York, New York, 10029
Warbasse Cares NORC
New York, New York, 11235
Rochdale Village NORC
New York, New York, 11434
About this study
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.
- Conditions
- Accidental Fall, Injury Prevention, Healthy Aging
- Being tested
- Outdoor Fall prevention brochure, Stroll Safe outdoor fall prevention program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outdoor Fall prevention brochureBehavioural
Participants in the wait list control group will initially receive written information only about preventing outdoor falls
Stroll Safe outdoor fall prevention programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Stroll Safe Program | Experimental | Not described Receives: Behavioral: Stroll Safe outdoor fall prevention program |
| Outdoor Fall Prevention Brochure | Active comparator | Not described Receives: Behavioral: Outdoor Fall prevention brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, following 7-week program, 2 months post program completion
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, every two weeks until 2 months post program completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start14 Jan 2019
- Primary completion10 Dec 2021
- Study completion18 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accidental FallStudies of the same condition, open and under way.
- More trials run by New York UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tracy Chippendale, PhD, OTR/L, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624777
- Sponsor's protocol ID
- Stroll Safe
- Status last verified
- May 2022
- First submitted
- 7 Aug 2018
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36148513
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Stroll Safe Outdoor Fall Prevention Program
- ClinicalTrials.gov ID
- NCT03624777
- Acronym / sponsor ID
- Stroll Safe
- Conditions
- Accidental Fall, Injury Prevention, Healthy Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 18 May 2022 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroll Safe Program | Experimental | Behavioral: Stroll Safe outdoor fall prevention program |
| Outdoor Fall Prevention Brochure | Active comparator | Behavioral: Outdoor Fall prevention brochure |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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?
Key exclusion criteria (1 listed)
- 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?
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outdoor Fall prevention brochureParticipants in the wait list control group will initially receive written information only about preventing outdoor falls | Behavioural | Outdoor Fall Prevention Brochure |
| Stroll Safe outdoor fall prevention programParticipants 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. | Behavioural | Stroll Safe Program |
Primary outcome
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.
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.
2 secondary outcomes
Change in Falls Self-Efficacy Scale-International
Time frame: Baseline, following 7-week program, 2 months post program completion
Change in fall diary reports
Time frame: Baseline, every two weeks until 2 months post program completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Derived from this study: PubMed 36148513Chippendale 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tracy Chippendale, PhD, OTR/L principal investigator
New York University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outdoor Fall prevention brochure and Stroll Safe outdoor fall prevention program in people with Accidental Fall and Injury Prevention, run by New York University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Outdoor Falls Questionnaire (Subscale score for strategy use) (time frame: Baseline, following 7-week program, 2 months post program completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03624777, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.