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

Education of Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03737097
• Other study ID #: HIAEfallMS
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2019
• Est. completion date: November 15, 2019

Study information

• Verified date: October 2018
• Source: Hospital Israelita Albert Einstein
• Contact: Daniella C Chanes, MSN
• Phone: 551121514368
• Email: daniella.chanes[@]einstein.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: November 15, 2019
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Multiple sclerosis diagnosis

• Accept to be part in the study

• Have valid e-mail address

Exclusion Criteria:

• Healthcare professionals;

Related Conditions & MeSH terms

• Education of Patients
• Multiple Sclerosis
• Sclerosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Sociedade Benef Israelitabras Hospital Albert Einstein	São Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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