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

Not Applicable

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT02885233
• Lead Sponsor: Oregon Health and Science University

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.

Study Timeline

• Study First Submitted: 2016-08-22
• Study First Submitted QC: 2016-08-25
• Study First Posted: 2016-08-31
• Study Start: 2017-02-15
• Primary Completion: 2018-01-25
• Study Completion: 2018-01-25
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-05
• Last Update Posted: 2018-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Difference in mean change in total falls between intervention and control arms	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 Outcome Measures

Name	Time	Method
Qualitative assessment of the web-based program	8 weeks	To determine usability and satisfaction with FFFO, subjects in the active group will complete a computer-based questionnaire at the end of the program. The investigators will qualitatively evaluate participant assessment of the FFFO program through the use of free-text responses.
Quantitative assessment of the web-based program	8 weeks	To determine usability and satisfaction with FFFO, subjects in the active group will complete a computer-based questionnaire at the end of the program. The investigators will quantitatively evaluate participant assessment of the FFFO program through the use of a 5-point Likert scale.
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	To determine if participation in FFFO is associated with improvement in patient reported outcomes, subjects will be randomly assigned to either the active intervention group or the waitlist control group. Outcomes will be measured through the use of the Patient Reported Outcomes Measurement Information System (PROMIS) which has been validated in people with multiple sclerosis. All subjects will complete the questionnaires at baseline, at 8 weeks and at 3 month follow-up. Scores will be compared between active and control subjects.

Trial Locations

Locations (1)

Oregon Health Sciences University; 🇺🇸 Portland, Oregon, United States