Online Spaced Education to Improve Fall Prevention by Patients With Multiple Sclerosis
Primary Purpose
Education of Patients
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Online Spaced Education
Brochure Education
Sponsored by
About this trial
This is an interventional health services research trial for Education of Patients focused on measuring Fall, Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria:
- Multiple sclerosis diagnosis
- Accept to be part in the study
- Have valid e-mail address
Exclusion Criteria:
- Healthcare professionals;
Sites / Locations
- Sociedade Benef Israelitabras Hospital Albert EinsteinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Online Spaced Education
Brochure Education
Arm Description
The intervention cohort will participate in an online spaced education on fall prevention education developed for patients with multiple sclerosis.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Fall rate
Number of self-reported falls registered by the patients in both cohorts will be compared in weeks 1, 12 and 24
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)
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.
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
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
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
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.
Full Information
NCT ID
NCT03737097
First Posted
October 29, 2018
Last Updated
February 28, 2019
Sponsor
Hospital Israelita Albert Einstein
1. Study Identification
Unique Protocol Identification Number
NCT03737097
Brief Title
Online Spaced Education to Improve Fall Prevention by Patients With Multiple Sclerosis
Official Title
Impact of Online Spaced Education on Long-term Retention of Knowledge About Fall Prevention by Patients With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 21, 2019 (Actual)
Primary Completion Date
October 15, 2019 (Anticipated)
Study Completion Date
November 15, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Israelita Albert Einstein
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Education of Patients
Keywords
Fall, Multiple Sclerosis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Both arms will take place in the same period.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Online Spaced Education
Arm Type
Experimental
Arm Description
The intervention cohort will participate in an online spaced education on fall prevention education developed for patients with multiple sclerosis.
Arm Title
Brochure Education
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Online Spaced Education
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Brochure Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in test scores between cohorts measured in weeks 1-24
Description
Test scores on fall prevention strategies tests in both cohorts will be registered and compared in weeks 1, 12 and 24
Time Frame
Months 1-6
Secondary Outcome Measure Information:
Title
Fall rate
Description
Number of self-reported falls registered by the patients in both cohorts will be compared in weeks 1, 12 and 24
Time Frame
Months 1-6
Title
Adherence to fall prevention strategies
Description
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)
Time Frame
Months 1-6
Title
Individuals satisfaction with the fall prevention education method
Description
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.
Time Frame
Months 3-6
Title
Baseline knowledge levels of patients assessed via their initial responses to the questions
Description
Previous knowledge about fall prevention strategies will be evaluated in week 1 in both cohorts and compared
Time Frame
Month 1
Title
Pre and post-test performances differences by age
Description
Patient performance will be evaluated in both cohorts and compared by age in weeks 1, 12 and 24
Time Frame
Month 1-6
Title
Pre and post-test performances differences by gender
Description
Patient performance will be evaluated in both cohorts and compared by gender in weeks 1, 12 and 24
Time Frame
Month 1-6
Title
Pre and post-test performances differences by history of falls
Description
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.
Time Frame
Months 1-6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Multiple sclerosis diagnosis
Accept to be part in the study
Have valid e-mail address
Exclusion Criteria:
- Healthcare professionals;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniella C Chanes, MSN
Phone
551121514368
Email
daniella.chanes@einstein.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar F Santos, PhD
Organizational Affiliation
MD
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eliseth R Leão, PhD
Organizational Affiliation
Researcher
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sociedade Benef Israelitabras Hospital Albert Einstein
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05652000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniella C Chanes, MSN
Phone
551121514368
Ext
74368
Email
daniella.chanes@einstein.br
First Name & Middle Initial & Last Name & Degree
Oscar P Santos, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
We do not plan to share IPD with other researchers
Learn more about this trial
Online Spaced Education to Improve Fall Prevention by Patients With Multiple Sclerosis
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