Evaluation of a Self-management Program to Prevent Falls in People With Multiple Sclerosis
Study Details
Study Description
Brief Summary
A co-design process was used to develop a digital group based self-management fall prevention program for people with multiple sclerosis (PwMS). The aim is to evaluate this program.
Research questions:
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Is the fall prevention program effective in reducing number of falls in PwMS at 6- and 12-months post-intervention?
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What contextual factors, mechanisms of impact and implementation aspects can likely explain the effects of the intervention?
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How do PwMS experience their fall prevention behaviours and strategies in daily life at 6- and 12-months post-intervention?
The program is evaluated in a randomized control trial regarding effect and process by quantitative and qualitative methods, in line with recommendation for complex interventions.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Fall prevention program + brochure 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 is 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 participants will receive a brochure about falls and fall risk factors.
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| Other: Brochure Brochure about falls and fall risk factors |
Other: Brochure
Control-group participants will receive a brochure about fall risk factors and fall prevention in addition to the standard MS care and rehabilitation.
|
Outcome Measures
Primary Outcome Measures
- Falls incidence [12-months post-intervention]
Falls will be monitored weekly via an online short message service. A lower number of falls means a better outcome
Secondary Outcome Measures
- Fall Prevention Strategy Survey [12-months post-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). The number of strategies used is calculated where a higher number of strategies i.e., a higher score, indicates a better outcome
- Measure of fear of falling [12-months post-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 [12-months post-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 [12-months post-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
- Frenchay Activities Index [12-months post-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).
- Multiple Sclerosis Impact Scale [12-months post-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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Community-dwelling adults
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Able to independently transfer from bed to chair or wheelchair with or without aids but without assistance of another person
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Have experienced one or more falls during the last year
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Able to understand and communicate in Swedish
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Ability to use and access to technical devices for online meetings i.e., computers or tablets with internet access.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Karolinska Institutet
Investigators
- Principal Investigator: Charlotte Y Ytterberg, PhD, Karolinska Institutet
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-02553