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

This study evaluates the effectiveness of a web-based fall prevention program called Free From Falls Online (FFFO) on people with multiple sclerosis.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Free From Falls Online; Behavioral: Waitlist Control

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health Sciences University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Free From Falls; 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.	Behavioral: Free From Falls Online; 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.
Placebo Comparator: Waitlist; 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.	Behavioral: Waitlist Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	5 months
Quantitative assessment of the web-based program	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.	8 weeks
Qualitative assessment of the web-based program	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.	8 weeks

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: University of Alabama at Birmingham
• Investigators: Principal Investigator: Michelle H Cameron, MD, Portland VA Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2017
• Primary Completion (Actual): January 25, 2018
• Study Completion (Actual): January 25, 2018

Study Registration Dates

• First Submitted: August 22, 2016
• First Submitted That Met QC Criteria: August 25, 2016
• First Posted (Estimate): August 31, 2016

Study Record Updates

• Last Update Posted (Actual): April 9, 2018
• Last Update Submitted That Met QC Criteria: April 5, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Self-efficacy; Fall Prevention; Web-based education
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 00015595

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No