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

NCT ID: NCT02885233

Last Updated: 2018-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-15

Study Completion Date

2018-01-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Free From Falls Online

Intervention Type BEHAVIORAL

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.

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.

Group Type PLACEBO_COMPARATOR

Waitlist Control

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michelle Cameron

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michelle H Cameron, MD

Role: PRINCIPAL_INVESTIGATOR

Portland VA Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Oregon Health Sciences University

Portland, Oregon, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

00015595

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.