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A Self-management Program to Prevent Falls in People With Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT04317716
Recruitment Status : Not yet recruiting
First Posted : March 23, 2020
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
Forte
Information provided by (Responsible Party):
Charlotte Ytterberg, Karolinska Institutet

Brief Summary:

This project's overall aim is to develop, deliver, and evaluate an innovative fall prevention program for ambulatory and non-ambulatory people with multiple sclerosis. The program will use a comprehensive intervention approach to address a variety of fall risk factors, and utilise self-management strategies. Specific aims are to 1) develop a fall prevention program, that addresses diverse fall risk factors and utilises self-management strategies, for ambulatory and non-ambulatory people with multiple sclerosis using a co-design process.

2) To determine if the fall prevention program is effective in reducing falls in ambulatory and non-ambulatory people with multiple sclerosis.

3) To identify change processes that can explain the potential effects of the fall prevention program.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: fall prevention program Other: brief advice about fall risk factors Not Applicable

Detailed Description:
In line with the recommendations for complex interventions, the fall prevention program will be developed and evaluated using quantitative and qualitative methods, and evaluation of both process (including feasibility) and outcome will occur. The program will be developed in a co-design process with people with multiple sclerosis and health professionals and evaluated via a randomised controlled trial. The Swedish MS-registry will be used to identify potential participants. MS specific representatives from the patient organisation Neuro Sweden will be involved in program design and implementation. The intervention group will receive the fall prevention program and the control group will receive group-based brief advice about fall risk factors.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be stratified for ambulation level (ambulatory/non-ambulatory) and a 1:1 allocation ratio of blocks of 10 will be used.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The facilitators of the fall prevention program will not be involved in the usual care of the participants. The intervention will take place at locations intended for patient education (i.e., separate from the regular clinical care) situated at the Academic Specialist Center of Neurology. Control-group participants will receive one two-hour session of group-based brief advice about fall risk factors at locations situated at the Medical Unit Occupational Therapy & Physiotherapy, Karolinska University Hospital. Baseline and follow-up assessments will be performed by blinded evaluators.
Primary Purpose: Prevention
Official Title: A Self-management Program to Prevent Falls in Ambulatory and Non-ambulatory Community Dwelling People With Multiple Sclerosis
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Fall prevention program
Behavioral: fall prevention program
The intervention consists of the fall prevention program for ambulatory and non-ambulatory people with multiple sclerosis. The program will be group-based with 6-8 participants, led by a facilitator (researcher), and performed in approximately six two-hour sessions, the first five over five consecutive weeks and the last final session held one month after the fifth session.

Control
Advice about fall risk factors
Other: brief advice about fall risk factors
Control-group participants will receive one two-hour session of group-based brief advice about fall risk factors at locations situated at the Medical Unit Occupational Therapy & Physiotherapy, Karolinska University Hospital. They will be advised to live their normal lives and receive usual care at the discretion of their physician since no treatment can be considered the gold standard.




Primary Outcome Measures :
  1. Falls incidence [ Time Frame: 15 months (from baseline to 12 months after end of intervention) ]
    Falls will be monitored via an online short message service (SMS). A SMS will be sent once a week (to avoid recall bias) asking "Have you fallen within the last week?" Participants answering "yes" will be contacted with questions regarding the circumstances of the fall.


Secondary Outcome Measures :
  1. Measure of fear of falling developed by Clemson et al 2015 [ Time Frame: Directly after the intervention and at 12 months after the end of the intervention ]

    Questionnaire with one question "Are you afraid of falling?" and six response options: Not at all afraid, Somewhat afraid, Fairly afraid, Very afraid, Don't know, Refused

    Not at all afraid Somewhat afraid Fairly afraid Very afraid Don't know Refused ARE YOU AFRAID OF FALLING?

    Not at all afraid Somewhat afraid Fairly afraid Very afraid Don't know Refused ARE YOU AFRAID OF FALLING?

    Not at all afraid Somewhat afraid Fairly afraid Very afraid Don't know Refused ARE YOU AFRAID OF FALLING?

    Not at all afraid Somewhat afraid Fairly afraid Very afraid Don't know Refused ARE YOU AFRAID OF FALLING?

    Not at all afraid Somewhat afraid Fairly afraid Very afraid Don't know Refused


  2. Falls Efficacy Scale -International [ Time Frame: Directly after the intervention and at 12 months after the end of the intervention ]
    Questionnaire that consists of 16 questions regarding 'how concerned' the person is when performing daily activities. Each question is answered with a four-graded scale (1-4); not at all concerned, somewhat concerned, fairly concerned and very concerned. A total score is calculated and ranges from 16 to 64

  3. Fall Prevention Strategy Scale [ Time Frame: Directly after the intervention and at 12 months after the end of the intervention ]
    The scale includes 14 fall prevention strategies. Participants report whether they currently use or have used the strategies to manage falls risk. If they are using it, they rate strategy effectiveness on a scale of 0-10. If they are not using it, they identify why (e.g., forgot, didn't think it would work, don't know how). This instrument produces three outcome indicators: (a) number of strategies used (pre and post intervention), (b) percent change in use for each individual strategy, and (c) the average effectiveness (self-rated)for the strategies used.

  4. Multiple Sclerosis Impact Scale [ Time Frame: Directly after the intervention and at 12 months after the end of the intervention ]
    29-item self-report measure with 20 items associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of multiple sclerosis on day-to-day life in the past two weeks. All items have 5 response options: 1 "not at all" to 5"extremely". Each of the two scales are scored by summing the responses across items, then converting to a 0-100 scale where 100 indicates greater impact of disease on daily function (worse health)

  5. EuroQol 5D-5L [ Time Frame: Directly after the intervention and at 12 months after the end of the intervention ]
    EuroQol 5D, consists of the EQ-5D Index and the EQ Visual Analog Scale. The EuroQol 5D comprises 5 pre-defined dimensions: Mobility, Self-care, Usual activities, Pain/discomfort and Anxiety/depression. The respondent rates each dimension on a three level scale as having no problem, a moderate problem or a severe problem. The answers are then converted to an index value (the EQ Index) ranging from 0 (death) to 1 (full health). The EQ VAS records the respondent's self-rated health on a 20-centimeter vertical visual analog scale with end-points ranging from 0 to 100. The single global question in the EQ VAS asks the individual to label his/her health as "the worst health you can imagine" (0) to "the best health you can imagine"

  6. Impact on Participation and Autonomy Questionnaire [ Time Frame: Directly after the intervention and at 12 months after the end of the intervention ]
    Measures two different aspects of participation: perceived participation and the experience of problems for each aspect of participation. The perceived participation scale consists of 31 items which are assessed using a 5 point rating scale (1=very good and 5=very poor) and the problem scale contains 8 items which are assessed using a 3 point rating scale (0=no problem and 2=severe problem). A participation score (range: 30-155) and a problem score (0-16) are produced by summing items in each scale.



Information from the National Library of Medicine

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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:

  • Community-dwelling adults aged ≥ 18 years
  • Diagnosed with multiple sclerosis
  • Able to understand and communicate in Swedish.

Exclusion Criteria:

  • Other conditions or diagnoses judged to potentially interfere with the trial.
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Responsible Party: Charlotte Ytterberg, associate professor (docent), Karolinska Institutet
ClinicalTrials.gov Identifier: NCT04317716    
Other Study ID Numbers: 2019-00457
First Posted: March 23, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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