Accidental FallsNCT02946593
Stroll Safe Outdoor Fall Prevention Program
A study testing Stroll Safe outdoor fall prevention program and Outdoor fall prevention brochure in people with Accidental Falls, run by New York University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls
- What is being tested?
- Stroll Safe outdoor fall prevention program and Outdoor fall prevention brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Aug 2017
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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.
- Conditions
- Accidental Falls
- Being tested
- Stroll Safe outdoor fall prevention program, Outdoor fall prevention brochure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stroll Safe outdoor fall prevention programBehavioural
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.
Outdoor fall prevention brochureBehavioural
The control group participants will be given a written brochure on tips for preventing outdoor falls.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 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. Receives: Behavioral: Stroll Safe outdoor fall prevention program |
| Control | Active comparator | Participants in the control group will receive written information about preventing outdoor falls. 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 (OFQ)
Measured: Baseline, following 7-week program, 2 months post program completion
Change in Falls Behavioral Scale for the Older Person (FaB)
Measured: Baseline, following 7-week program, 2 months post program completion
Change in Falls Self-efficacy Scale- International (FES-I)
Measured: Baseline, following 7-week program, 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 posted27 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946593
- Sponsor's protocol ID
- NewYorkU
- Status last verified
- Sep 2017
- First submitted
- 24 Oct 2016
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Clark F, Jackson J, Carlson M, Chou CP, Cherry BJ, Jordan-Marsh M, Knight BG, Mandel D, Blanchard J, Granger DA, Wilcox RR, Lai MY, White B, Hay J, Lam C, Marterella A, Azen SP. Effectiveness of a lifestyle intervention in promoting the well-being of independently living older people: results of the Well Elderly 2 Randomised Controlled Trial. J Epidemiol Community Health. 2012 Sep;66(9):782-90. doi: 10.1136/jech.2009.099754. Epub 2011 Jun 2.
PubMed 21636614Delbaere K, Close JC, Mikolaizak AS, Sachdev PS, Brodaty H, Lord SR. The Falls Efficacy Scale International (FES-I). A comprehensive longitudinal validation study. Age Ageing. 2010 Mar;39(2):210-6. doi: 10.1093/ageing/afp225. Epub 2010 Jan 8.
PubMed 20061508Chippendale T. Development and validity of the Outdoor Falls Questionnaire. Int J Rehabil Res. 2015 Sep;38(3):263-9. doi: 10.1097/MRR.0000000000000115.
PubMed 25851838Clemson L, Bundy AC, Cumming RG, Kay L, Luckett T. Validating the Falls Behavioural (FaB) scale for older people: a Rasch analysis. Disabil Rehabil. 2008;30(7):498-06. doi: 10.1080/09638280701355546.
PubMed 17852314
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroll Safe Outdoor Fall Prevention Program
- ClinicalTrials.gov ID
- NCT02946593
- Acronym / sponsor ID
- NewYorkU
- Conditions
- Accidental Falls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 27 Oct 2016 (estimated)
- 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: 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. |
| Control | Active comparator | Behavioral: Outdoor fall prevention brochureParticipants in the control group will receive written information about preventing outdoor falls. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Stroll Safe outdoor fall prevention programThe 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. | Behavioural | Treatment |
| Outdoor fall prevention brochureThe control group participants will be given a written brochure on tips for preventing outdoor falls. | Behavioural | Control |
Primary outcome
Change in Outdoor Falls Questionnaire (OFQ)
Time frame: 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
Change in Falls Self-efficacy Scale- International (FES-I)
Time frame: Baseline, following 7-week program, 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 3 Nov 2022.
- Background: PubMed 21636614Clark F, Jackson J, Carlson M, Chou CP, Cherry BJ, Jordan-Marsh M, Knight BG, Mandel D, Blanchard J, Granger DA, Wilcox RR, Lai MY, White B, Hay J, Lam C, Marterella A, Azen SP. Effectiveness of a lifestyle intervention in promoting the well-being of independently living older people: results of the Well Elderly 2 Randomised Controlled Trial. J Epidemiol Community Health. 2012 Sep;66(9):782-90. doi: 10.1136/jech.2009.099754. Epub 2011 Jun 2.
- Background: PubMed 20061508Delbaere K, Close JC, Mikolaizak AS, Sachdev PS, Brodaty H, Lord SR. The Falls Efficacy Scale International (FES-I). A comprehensive longitudinal validation study. Age Ageing. 2010 Mar;39(2):210-6. doi: 10.1093/ageing/afp225. Epub 2010 Jan 8.
- Background: PubMed 25851838Chippendale T. Development and validity of the Outdoor Falls Questionnaire. Int J Rehabil Res. 2015 Sep;38(3):263-9. doi: 10.1097/MRR.0000000000000115.
- Background: PubMed 17852314Clemson L, Bundy AC, Cumming RG, Kay L, Luckett T. Validating the Falls Behavioural (FaB) scale for older people: a Rasch analysis. Disabil Rehabil. 2008;30(7):498-06. doi: 10.1080/09638280701355546.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stroll Safe outdoor fall prevention program and Outdoor fall prevention brochure in people with Accidental Falls, run by New York University at 1 site 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 6 inclusion and 6 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 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (OFQ) (time frame: Baseline, following 7-week program, 2 months post program completion). The study lists 3 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 NCT02946593, which also lists 4 linked publications.
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 3 Nov 2022; AzTrials last refreshed its copy on 27 Oct 2026.