Evaluation of a Self-management Program to Prevent Falls in People With Multiple Sclerosis

Study Overview
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Brief Summary
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The goal of this randomized controlled trial is to evaluate the effects of a digital group based self-management fall prevention program, Fewer Falls in MS, in people with multiple sclerosis (PwMS). The main questions it aims to answer are:. Is the Fewer falls in MS program effective in reducing fall incidence in PwMS at 6 and 12 months after start of intervention? Does the program have an effect on secondary outcomes at 3, 6 and 12 months? What experiences of participation, contextual factors, mechanisms of impact, and implementation aspects can likely explain the effects of the intervention? How do PwMS experience their fall prevention behaviours and strategies in daily life, 6- and 12-months after start of intervention? What is the cost effectiveness of the fall prevention program 12 months after start of intervention? Participants in the intervention group will participate in a group-based self-management fall prevention intervention of eight 2-hour sessions delivered online by a trained group leader. Home assignments are completed by the participants between group sessions. Participants in the intervention group and the control group will receive a brochure on fall risk factors and fall prevention Researchers will compare the intervention group and the control group to see if there are any differences in fall incidence, sense of control of falls prevention, fear of falling, falls self-efficacy, activity curtailment, perceived impact of MS, self-reported health, and health economic costs. Researchers will also study factors and mechanisms that support or hinder how the fall prevention program builds participants' ability to manage their fall risk; and if and how PwMS have implemented and use self-management fall prevention behaviours into their daily lives.

Official Title
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Evaluation of a Self-management Program to Prevent Falls in Ambulatory and Non-ambulatory People With Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Fall prevention program
* Other: Brochure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PwMS aged ≥ 18 years Able to walk or independently transfer from bed to chair or wheelchair with or without aids but without assistance of another person Have experienced one or more falls during the last year Able to understand and communicate in Swedish Self-rated ability to use and access to technical devices for online meetings i.e., computers or tablets with internet access and mobile phones to receive and send short message service

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be stratified for ambulation level (ambulatory/non-ambulatory) and a 1:1 allocation ratio of blocks of 8 will be used for randomization.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fall prevention program + brochure<br>Fall prevention program and brochure about falls and fall risk factors | Behavioral: Fall prevention program<br>* The intervention consists of the fall prevention program for ambulatory and non-ambulatory people with multiple sclerosis. The program is group-based with 8 participants in each group, led by a facilitator, and performed online. It comprises seven two-hour sessions held once a week, and a booster session held four weeks after the seventh session. In addition participants will receive a brochure about falls and fall risk factors.<br>|
| Active Comparator: Brochure<br>Brochure about falls and fall risk factors | Other: Brochure<br>* Control-group participants will receive a brochure about fall risk factors and fall prevention in addition to the standard MS care and rehabilitation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Falls incidence | Falls will be monitored weekly via an online short message service. A lower number of falls means a better outcome | 6 and 12-months after start of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Falls Control Scale | Questionnaire that includes four statements with which the participants agree or disagree on a scale from 1 to 4 where a higher score indicates better falls control. | 3, 6 and 12-months after start of intervention | 
| Measure of fear of falling | Questionnaire with one question Are you afraid of falling? and five response options: Not at all afraid, Somewhat afraid, Fairly afraid, Very afraid, Extremely afraid | 3, 6 and 12-months after start of intervention | 
| Falls Efficacy Scale-International | 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, higher scores indicate worse outcome. | 3, 6 and 12-months after start of intervention | 
| Spinal Cord Injury Fall Concern Scale | Questionnaire that addresses concern about falling during 16 activities of daily living associated with falling, scored on a 4-point scale (1=not at all concerned to 4=very concerned. The total score is calculated by summing the scores for each activity, with a possible range between 16 and 64, higher scores indicate worse outcome. | 3, 6 and 12-months after start of intervention | 
| Revised version of the Short Falls Efficacy Scale-International | Questionnaire that consists of seven 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 7 to 27, higher scores indicate worse outcome. | 3, 6 and 12-months after start of intervention | 
| Activity curtailment | Questionnaire with one question Do you think fear of falling has made you cut down on any activities that you used to do? with four response options: Yes, No, Don't know, Refuse to answer | 3, 6 and 12-months after start of intervention | 
| Multiple Sclerosis Impact Scale | Questionnaire - 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 5extremely. 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, i.e. worse outcome. | 3, 6 and 12-months after start of intervention | 
| EuroQol-5D-5L | Questionnaire consisting of the EQ-5D Index and the EQ Visual Analogue Scale. The EuroQol 5D-5L comprises five pre-defined dimensions: Mobility, Self-care, Usual activities, Pain/discomfort and Anxiety/depression. The respondent rates each dimension on a five level scale as having no problem, slight problems, moderate problem, severe problem, unable or extreme. The answers are then converted to an index value (the EQ Index) ranging from 0 (representing death) to 1 (full health). The EQ VAS records the respondent's self-rated health on a 20-centimeter vertical visual analo,g 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 | 3, 6 and 12-months after start of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-management, Accidental Falls, Health Economics, Randomized Controlled Trial, Complex Intervention, Process Evaluation, Group-based, Online Intervention, Short Message Service