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

Study Overview
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Brief Summary
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This project's overall aim is to develop, deliver, and evaluate feasibility of a 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 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. To examine feasibility, acceptability, fidelity, and potential outcome of the online, co-designed self-management fall prevention intervention for ambulatory and non-ambulatory people with multiple sclerosis, and to examine feasibility of the recruitment process, the data collection procedures, and the outcome measures.

Detailed Description
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Falls among people with multiple sclerosis (PwMS) are common and associated with injuries, fear of falling and low health-related quality of life. Considerations of behavioural, environmental, psychological and physical influences (including ambulation status) are needed to meet fall prevention needs for PwMS. Thus, using a codesign process involving key stakeholders a novel online self-management fall prevention intervention will be created specifically for ambulatory and non-ambulatory PwMS. The feasibility, acceptability, fidelity and outcome of this complex intervention will be explored. Findings will inform a future full-scale randomised controlled trial. A mixed-method design will be used. Forty-eight PwMS, stratified for ambulation level, will be randomised to control (n=24) or intervention (n=24). Both groups will receive a brochure about fall risk factors and fall prevention. The intervention is group-based (eight PwMS in each group); will be delivered online; and involve six, 2-hour weekly sessions and a booster session 8 weeks after the sixth session. Each intervention group will be led by a trained facilitator. Data collection will be performed at baseline, and after seven and 18 weeks. Outcome measures will capture data on fall prevention behaviours, fear of falling, falls self-efficacy, social and everyday activities, perceived impact of MS and number of falls. Feasibility of recruitment process, data collection procedures, outcome measures, and delivery, and intervention acceptability, fidelity and outcomes will be evaluated. Both quantitative and qualitative methods will be used.

Official Title
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A Self-management Program to Prevent Falls in Ambulatory and Non-ambulatory Community Dwelling People With Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: fall prevention program
* Other: Brochure about falls and fall risk factors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Community-dwelling adults aged ≥ 18 years Diagnosed with multiple sclerosis Able to independently transfer from bed to wheelchair with or without aids but without assistance of another person Able to understand and communicate in Swedish Able to use and access to technical devices for online meetings i.e., computers or tablets with internet access

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 4 will be used.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<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 will be group-based with 6-8 participants, led by a facilitator, and performed online. It comprises six two-hour sessions held once a week, and a booster session held eight weeks after the sixth session. In addition they will receive a brochure about falls and fall risk factors.<br>|
| Other: Control<br>Bbrochure about falls and fall risk factors | Other: Brochure about falls and fall risk factors<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 |
| --- | --- | --- |
| Fall Prevention Strategy Survey | 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). The number of strategies used is calculated where a higher number of strategies indicate a better outcome | Change from baseline in number of strategies used at 18 weeks after the start of the intervention/control period | 
| Fall Prevention Strategy Survey | 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). The number of strategies used is calculated where a higher number of strategies indicate a better outcome | Number of strategies used at 18 weeks after the start of the intervention/control period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Falls incidence | Falls will be monitored via an online short message service (SMS) and interview | Weekly from baseline to the 18-week follow-up | 
| Measure of fear of falling | 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 | At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period | 
| 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 | At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period | 
| Spinal Cord Injury Fall Concern Scale | 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 | At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period | 
| Multiple Sclerosis Impact Scale | 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 | At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period | 
| Frenchay Activities Index | Measures frequency of social and everyday activities. The Frenchay Activities Index consists of 15 items and the score is based on the frequency with which an activity has been performed during the previous 3 or 6 months. The total score ranges from 0 (inactive) to 45 (very active). | At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Feasibility Studies, Accidental Falls, Self-management, Complex Intervention, Group-based, Online Intervention, Short Message Service