Online Spaced Education to Improve Fall Prevention by Patients With Multiple Sclerosis

Impact of Online Spaced Education on Long-term Retention of Knowledge About Fall Prevention by Patients With Multiple Sclerosis

Multiple sclerosis (MS) is a chronic, progressive and neurodegenerative inflammatory disease that affects young adults. In many countries it has been described as the main cause of neurological incapacity in this age group. Due to the neurological impairment, patients with multiple sclerosis have a high incidence of fall. According to studies, MS patients fall three times more than general population. In the present study, the question to be answered is: education of individuals with MS on fall prevention using the method of online spaced education provides better retention of knowledge than the traditional method? This is a clinical trial to compare two methods of education of MS patients for prevention of fall. First stage: Development and validation of materials. Step two: Pilot questions with MS patients. Step three: Intervention and evaluation of outcome.

Study Overview

• Status: Unknown
• Conditions: Education of Patients
• Intervention / Treatment: Other: Online Spaced Education; Other: Brochure Education

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • São Paulo, Sao Paulo, Brazil, 05652000
      • Recruiting
      • Sociedade Benef Israelitabras Hospital Albert Einstein
      • Contact: Daniella C Chanes, MSN; Phone Number: 74368 551121514368; Email: daniella.chanes@einstein.br
      • Principal Investigator: Oscar P Santos, PhD

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:

• Multiple sclerosis diagnosis
• Accept to be part in the study
• Have valid e-mail address

Exclusion Criteria:

- Healthcare professionals;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Online Spaced Education; The intervention cohort will participate in an online spaced education on fall prevention education developed for patients with multiple sclerosis.	Other: Online Spaced Education; Investigators created a set of fall prevention strategies for multiple sclerosis patients into an evidence-based form of online education, termed 'spaced education' (SE). Based upon two psychology research findings (the spacing and testing effects), spaced education has been shown in randomized trials to improve knowledge acquisition, boosts learning retention for up to two years, and durably improves changes in behavior.
Active Comparator: Brochure Education; The control cohort will receive the fall prevention education in bolus through a Brochure developed by the National Multiple Sclerosis Society. The brochure was translated to portuguese and will be used in the study with authorization of the Society.	Other: Brochure Education; The investigators translated and validated the Minimizing Your Risk of Falls A GUIDE FOR PEOPLE WITH MS brochure developed by the National Multiple Sclerosis Society. The control cohort will receive the main education model for patients that has been used in the past few years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in test scores between cohorts measured in weeks 1-24	Test scores on fall prevention strategies tests in both cohorts will be registered and compared in weeks 1, 12 and 24	Months 1-6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fall rate	Number of self-reported falls registered by the patients in both cohorts will be compared in weeks 1, 12 and 24	Months 1-6
Adherence to fall prevention strategies	The study will apply the Falls Prevention Strategies Survey in both cohorts in weeks 1, 12 and 24. It is a self-report instrument addressing protective behaviors related to fall risk among adults with multiple sclerosis (MS) (eg, monitoring MS symptoms, wearing proper footwear, modifying activities). Response options reflect the frequency with which the respondent engages in the behavior (ie, never, sometimes, regularly)	Months 1-6
Individuals satisfaction with the fall prevention education method	Individuals will be asked to evaluate their satisfaction with the method they were signed in the study by a five-point Likert scale (very dissatisfied, dissatisfied, neutral, satisfied, very satisfied). Answers will be compared between both cohorts in weeks 12 and 24.	Months 3-6
Baseline knowledge levels of patients assessed via their initial responses to the questions	Previous knowledge about fall prevention strategies will be evaluated in week 1 in both cohorts and compared	Month 1
Pre and post-test performances differences by age	Patient performance will be evaluated in both cohorts and compared by age in weeks 1, 12 and 24	Month 1-6
Pre and post-test performances differences by gender	Patient performance will be evaluated in both cohorts and compared by gender in weeks 1, 12 and 24	Month 1-6
Pre and post-test performances differences by history of falls	Patient performance in pre and post-tests will be evaluated in both cohorts and will be compared between fallers and non-fallers in the group and between the cohorts in weeks 1, 12 and 24. We will consider fallers the individuals, in both groups, that have at least one reported fall in the past six months in the enrollment in the study.	Months 1-6

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein
• Investigators: Study Director: Oscar F Santos, PhD, MD; Principal Investigator: Eliseth R Leão, PhD, Researcher

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2019
• Primary Completion (Anticipated): October 15, 2019
• Study Completion (Anticipated): November 15, 2019

Study Registration Dates

• First Submitted: October 29, 2018
• First Submitted That Met QC Criteria: November 7, 2018
• First Posted (Actual): November 9, 2018

Study Record Updates

• Last Update Posted (Actual): March 1, 2019
• Last Update Submitted That Met QC Criteria: February 28, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Fall
• 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: HIAEfallMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We do not plan to share IPD with other researchers

Drug and device information, study documents

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