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Clinical Trials/NCT02885233
NCT02885233
Completed
Not Applicable

Evaluation of a Web-Based Fall Prevention Program on People With Multiple Sclerosis

Oregon Health and Science University1 site in 1 country30 target enrollmentFebruary 15, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Oregon Health and Science University
Enrollment
30
Locations
1
Primary Endpoint
Difference in mean change in total falls between intervention and control arms
Status
Completed
Last Updated
8 years ago

Overview

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.

Detailed Description

The overarching goal of this study is to evaluate the effectiveness and impact of an online self-management program for preventing falls among people with multiple sclerosis (PwMS). To accomplish this objective, the investigators have designed a web-based fall prevention program called Free From Falls Online (FFFO), based on the traditionally in-person program developed by the National Multiple Sclerosis Society. The specific aims of this study are three-fold: (1) to evaluate the effectiveness of an online fall prevention self-education program by comparing fall frequency between participants and controls; (2) evaluate the impact of FFFO by comparing patient reported measures of physical function, fatigue, self-efficacy, psychosocial illness impact, social participation and satisfaction, and perception of global health between participants and controls; (3) and to determine usability of and satisfaction with FFFO.

Registry
clinicaltrials.gov
Start Date
February 15, 2017
End Date
January 25, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michelle Cameron

Associate Professor

Oregon Health and Science University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Medical conditions that would preclude reliable participation or increases risk for injury during the program

Outcomes

Primary Outcomes

Difference in mean change in total falls between intervention and control arms

Time Frame: 5 months

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.

Secondary Outcomes

  • Qualitative assessment of the web-based program(8 weeks)
  • Quantitative assessment of the web-based program(8 weeks)
  • 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)

Study Sites (1)

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