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Trial record 7 of 560 for:    Recruiting, Not yet recruiting, Available Studies | Teaching

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

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ClinicalTrials.gov Identifier: NCT03737097
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital Israelita Albert Einstein

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.

Condition or disease Intervention/treatment Phase
Education of Patients Other: Online Spaced Education Other: Brochure Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Both arms will take place in the same period.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Impact of Online Spaced Education on Long-term Retention of Knowledge About Fall Prevention by Patients With Multiple Sclerosis
Actual Study Start Date : February 21, 2019
Estimated Primary Completion Date : October 15, 2019
Estimated Study Completion Date : November 15, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in test scores between cohorts measured in weeks 1-24 [ Time Frame: Months 1-6 ]
    Test scores on fall prevention strategies tests in both cohorts will be registered and compared in weeks 1, 12 and 24


Secondary Outcome Measures :
  1. Fall rate [ Time Frame: Months 1-6 ]
    Number of self-reported falls registered by the patients in both cohorts will be compared in weeks 1, 12 and 24

  2. Adherence to fall prevention strategies [ Time Frame: Months 1-6 ]
    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)

  3. Individuals satisfaction with the fall prevention education method [ Time Frame: Months 3-6 ]
    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.

  4. Baseline knowledge levels of patients assessed via their initial responses to the questions [ Time Frame: Month 1 ]
    Previous knowledge about fall prevention strategies will be evaluated in week 1 in both cohorts and compared

  5. Pre and post-test performances differences by age [ Time Frame: Month 1-6 ]
    Patient performance will be evaluated in both cohorts and compared by age in weeks 1, 12 and 24

  6. Pre and post-test performances differences by gender [ Time Frame: Month 1-6 ]
    Patient performance will be evaluated in both cohorts and compared by gender in weeks 1, 12 and 24

  7. Pre and post-test performances differences by history of falls [ Time Frame: Months 1-6 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Healthcare professionals;


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03737097


Contacts
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Contact: Daniella C Chanes, MSN 551121514368 daniella.chanes@einstein.br

Locations
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Brazil
Sociedade Benef Israelitabras Hospital Albert Einstein Recruiting
São Paulo, Sao Paulo, Brazil, 05652000
Contact: Daniella C Chanes, MSN    551121514368 ext 74368    daniella.chanes@einstein.br   
Principal Investigator: Oscar P Santos, PhD         
Sponsors and Collaborators
Hospital Israelita Albert Einstein
Investigators
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Study Director: Oscar F Santos, PhD MD
Principal Investigator: Eliseth R Leão, PhD Researcher

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Responsible Party: Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT03737097     History of Changes
Other Study ID Numbers: HIAEfallMS
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We do not plan to share IPD with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital Israelita Albert Einstein:
Fall
Multiple Sclerosis
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases