A Self-management Program to Prevent Falls in People With Multiple Sclerosis
Study Details
Study Description
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.
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To examine acceptability and feasibility of the co-designed fall prevention program, and feasibility of recruitment and data collection procedures 3) To determine if the fall prevention program is effective in reducing falls in ambulatory and non-ambulatory people with multiple sclerosis.
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To identify change processes that can explain the potential effects of the fall prevention program.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 feasibility, process and outcome will occur. The program will be developed in a co-design process with people with multiple sclerosis and health professionals and evaluated in a feasibility study and in a randomised controlled trial. 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 a brochure about falls and fall risk factors. The control group will receive a brochure about falls and fall risk factors.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention Fall prevention program and brochure about falls and fall risk factors |
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, 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.
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| Other: Control Bbrochure about falls and fall risk factors |
Other: Brochure about falls and fall risk factors
Control-group participants will receive a brochure about falls and fall risk factors, posted by mail. 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.
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Outcome Measures
Primary Outcome Measures
- Fall Prevention Strategy Scale [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.
Secondary Outcome Measures
- Falls incidence [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.
- Measure of fear of falling developed by Clemson et al 2015 [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
- Falls Efficacy Scale -International [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
- Spinal Cord Injury Fall Concern Scale [Directly after the intervention and at 12 months after the end of the intervention]
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
- Multiple Sclerosis Impact Scale [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
- Frenchay Activities Index [Directly after the intervention and at 12 months after the end of the intervention]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Community-dwelling adults aged ≥ 18 years
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Diagnosed with multiple sclerosis
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Able to independently transfer from bed to wheelchair with or without aids but without assistance of another person
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Able to understand and communicate in Swedish
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Able to use and access to technical devices for online meetings i.e., computers or tablets with internet access
Exclusion Criteria:
- Other conditions or diagnoses judged to potentially interfere with the trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Academic Specialist Centre of Neurology | Stockholm | Sweden | ||
| 2 | Karolinska University Hospital | Stockholm | Sweden |
Sponsors and Collaborators
- Karolinska Institutet
- Forte
- The Swedish Research Council
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019-00457