Evaluation of a Web-Based Fall Prevention Program on People With Multiple Sclerosis
1 other identifier
interventional
30
1 country
1
Brief Summary
This study evaluates the effectiveness of a web-based fall prevention program called Free From Falls Online (FFFO) on people with multiple sclerosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable multiple-sclerosis
Started Feb 2017
Shorter than P25 for not_applicable multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2016
CompletedFirst Posted
Study publicly available on registry
August 31, 2016
CompletedStudy Start
First participant enrolled
February 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2018
CompletedApril 9, 2018
April 1, 2018
11 months
August 22, 2016
April 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in mean change in total falls between intervention and control arms
To determine if participation in FFFO is associated with decreased frequency of falls, subjects will be randomly assigned to either the active intervention group or the waitlist control group. All subjects will prospectively document the number and circumstances of their falls for 5 months through the use of an electronic survey, to include the 8 weeks of the active or control intervention and 3-month follow-up. The primary outcome will be the difference in fall frequency between active and control subjects.
5 months
Secondary Outcomes (3)
Difference in patient reported outcomes including physical function, fatigue, self efficacy, psychosocial illness impact, social participation and satisfaction, and perception of global health between intervention and control arms.
5 months
Quantitative assessment of the web-based program
8 weeks
Qualitative assessment of the web-based program
8 weeks
Study Arms (2)
Free From Falls
ACTIVE COMPARATORSubjects in the active group will participate in the Free From Falls Online Program consisting of 8 weekly 30 minute webinars providing education about risk factors for falls and fall prevention strategies; self-assessment exercises to evaluate understanding of the material; video-based exercise program targeting balance, posture, strength and flexibility to be performed at least 3 times per week; supplementary, downloadable printed material for both education and exercise; and a social forum to allow participants to interact with each other.
Waitlist
PLACEBO COMPARATORSubjects in the waitlist control condition will receive an educational brochure developed by the National Multiple Sclerosis Society called "Minimizing Your Risk of Falls: A Guide for People with MS," which includes information on identifying risk factors for falling and fall risk management approaches with no exercise component; will inform their provider that they have fallen at least twice in the previous 2 months and discuss subsequent falls over the course of the 5-month study; and will be invited to participate in the Free From Falls Online Program at study completion.
Interventions
Subjects in the active group will participate in the Free From Falls Online Program consisting of 8 weekly 30 minute webinars providing education about risk factors for falls and fall prevention strategies; self-assessment exercises to evaluate understanding of the material; video-based exercise program targeting balance, posture, strength and flexibility to be performed at least 3 times per week; supplementary, downloadable printed material for both education and exercise; and a social forum to allow participants to interact with each other.
Subjects in the waitlist control condition will receive an educational brochure developed by the National Multiple Sclerosis Society called "Minimizing Your Risk of Falls: A Guide for People with MS," which includes information on identifying risk factors for falling and fall risk management approaches with no exercise component; will inform their provider that they have fallen at least twice in the previous 2 months and discuss subsequent falls over the course of the 5-month study; and will be invited to participate in the Free From Falls Online Program at study completion.
Eligibility Criteria
You may qualify if:
- MS of any type with no relapse in the previous month
- Self-reported history of 2 or more falls in the previous 2 months
- Ability to walk at least 100 meters with intermittent or unilateral constant assistance (Expanded Disability Severity Scale (EDSS) step \<6.0)
- Daily access a computer and willingness to respond to a daily survey
You may not qualify if:
- Medical conditions that would preclude reliable participation or increases risk for injury during the program
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oregon Health Sciences University
Portland, Oregon, 97239, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle H Cameron, MD
Portland VA Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 22, 2016
First Posted
August 31, 2016
Study Start
February 15, 2017
Primary Completion
January 25, 2018
Study Completion
January 25, 2018
Last Updated
April 9, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share