Education of PatientsNCT03737097
Online Spaced Education to Improve Fall Prevention by Patients With Multiple Sclerosis
A study testing Online Spaced Education and Brochure Education in people with Education of Patients, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Education of Patients
- What is being tested?
- Online Spaced Education and Brochure Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteBrazil
- Study dates
- 21 Feb 2019to 15 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Multiple sclerosis diagnosis
- Accept to be part in the study
- Have valid e-mail address
Who cannot join
- Healthcare professionals;
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Sociedade Benef Israelitabras Hospital Albert Einstein
São Paulo, São Paulo, 05652000
Daniella C Chanes, MSN, 551121514368 ext. 74368, daniella.chanes@einstein.br
Oscar P Santos, PhD
About this study
Official title: 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.
- Conditions
- Education of Patients
- Being tested
- Online Spaced Education, Brochure Education
- Keywords
- Fall, Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Online Spaced Education | Experimental | The intervention cohort will participate in an online spaced education on fall prevention education developed for patients with multiple sclerosis. Receives: 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. Receives: Other: Brochure Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Months 1-6
Secondary outcomes (7)
Fall rate
Number of self-reported falls registered by the patients in both cohorts will be compared in weeks 1, 12 and 24
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Months 1-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start21 Feb 2019
- Primary completion15 Oct 2019 (estimated)
- Study completion15 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Education of PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Both arms will take place in the same period.
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oscar F Santos, PhD, Study director, MDEliseth R Leão, PhD, Principal investigator, Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737097
- Sponsor's protocol ID
- HIAEfallMS
- Status last verified
- Oct 2018
- First submitted
- 29 Oct 2018
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We do not plan to share IPD with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Online Spaced Education on Long-term Retention of Knowledge About Fall Prevention by Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03737097
- Acronym / sponsor ID
- HIAEfallMS
- Conditions
- Education of Patients
- Keywords
- Fall, Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 15 Oct 2019 (estimated)
- Study completion
- 15 Nov 2019 (estimated)
- First posted
- 9 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Both arms will take place in the same period.
| Arm | Type | Receives |
|---|---|---|
| Online Spaced Education | Experimental | Other: Online Spaced EducationThe intervention cohort will participate in an online spaced education on fall prevention education developed for patients with multiple sclerosis. |
| Brochure Education | Active comparator | Other: Brochure EducationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Multiple sclerosis diagnosis
- Accept to be part in the study
- Have valid e-mail address
Key exclusion criteria (1 listed)
- Healthcare professionals;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Spaced EducationInvestigators 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. | Other | Online Spaced Education |
| Brochure EducationThe 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. | Other | Brochure Education |
Primary outcome
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
7 secondary outcomes
Fall rate
Time frame: Months 1-6
Adherence to fall prevention strategies
Time frame: Months 1-6
Individuals satisfaction with the fall prevention education method
Time frame: Months 3-6
Baseline knowledge levels of patients assessed via their initial responses to the questions
Time frame: Month 1
Pre and post-test performances differences by age
Time frame: Month 1-6
Pre and post-test performances differences by gender
Time frame: Month 1-6
Pre and post-test performances differences by history of falls
Time frame: Months 1-6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Individual participant dataSharing planned: Undecided. We do not plan to share IPD with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oscar F Santos, PhD study director
MD
Eliseth R Leão, PhD principal investigator
Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Spaced Education and Brochure Education in people with Education of Patients, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniella C Chanes, MSN (551121514368, daniella.chanes@einstein.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in test scores between cohorts measured in weeks 1-24 (time frame: Months 1-6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019.