Clinical trial NCT02946593: Stroll Safe Outdoor Fall Prevention Program
Official title: Stroll Safe Outdoor Fall Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Falls
Lead sponsor: New York University
Sponsor class: OTHER
First posted: 2016-10-27
Enrollment: 24
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change in Outdoor Falls Questionnaire (OFQ)
timeFrame: Baseline, following 7-week program, 2 months post program completion
measure: Change in Falls Behavioral Scale for the Older Person (FaB)
timeFrame: Baseline, following 7-week program, 2 months post program completion
measure: Change in Falls Self-efficacy Scale- International (FES-I)
timeFrame: Baseline, following 7-week program, 2 months post program completion
Secondary outcomes:
Other outcomes:
measure: Change in Fall diary reports
timeFrame: At baseline, every two weeks until 2 months post program completion
Locations:
city: New York
country: United States
facility: New York University
state: New York
Study officials:
References:
citation: 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.
citation: Delbaere 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.
citation: Chippendale T. Development and validity of the Outdoor Falls Questionnaire. Int J Rehabil Res. 2015 Sep;38(3):263-9. doi: 10.1097/MRR.0000000000000115.
citation: Clemson 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.