NCT03737097

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 9, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

February 21, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2019

Completed
Last Updated

March 1, 2019

Status Verified

October 1, 2018

Enrollment Period

8 months

First QC Date

October 29, 2018

Last Update Submit

February 28, 2019

Conditions

Education of Patients

Keywords

FallMultiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Fall rate

    Months 1-6

  • Adherence to fall prevention strategies

    Months 1-6

  • Individuals satisfaction with the fall prevention education method

    Months 3-6

  • Baseline knowledge levels of patients assessed via their initial responses to the questions

    Month 1

  • Pre and post-test performances differences by age

    Month 1-6

  • +2 more secondary outcomes

Study Arms (2)

Online Spaced Education

EXPERIMENTAL

The intervention cohort will participate in an online spaced education on fall prevention education developed for patients with multiple sclerosis.

Other: Online Spaced Education

Brochure Education

ACTIVE COMPARATOR

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

Interventions

Online Spaced EducationOTHER

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.

Online Spaced Education
Brochure EducationOTHER

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.

Brochure Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- Healthcare professionals;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sociedade Benef Israelitabras Hospital Albert Einstein

São Paulo, São Paulo, 05652000, Brazil

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Oscar F Santos, PhD

    MD

    STUDY DIRECTOR

  • Eliseth R Leão, PhD

    Researcher

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniella C Chanes, MSN

CONTACT

551121514368daniella.chanes@einstein.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Both arms will take place in the same period.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2018

First Posted

November 9, 2018

Study Start

February 21, 2019

Primary Completion

October 15, 2019

Study Completion

November 15, 2019

Last Updated

March 1, 2019

Record last verified: 2018-10

Locations

BR(1)