A Self-management Program to Prevent Falls in People With Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
fall prevention program
Brochure about falls and fall risk factors
Sponsored by

About this trial
This is an interventional prevention trial for Multiple Sclerosis
Eligibility Criteria
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
Exclusion Criteria:
- Other conditions or diagnoses judged to potentially interfere with the trial
Sites / Locations
- Academic Specialist Centre of Neurology
- Karolinska University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention
Control
Arm Description
Fall prevention program and brochure about falls and fall risk factors
Bbrochure about falls and fall risk factors
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Falls incidence
Falls will be monitored via an online short message service (SMS) and interview
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
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
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
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 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
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).
Full Information
NCT ID
NCT04317716
First Posted
March 19, 2020
Last Updated
December 1, 2022
Sponsor
Karolinska Institutet
Collaborators
Forte, The Swedish Research Council
1. Study Identification
Unique Protocol Identification Number
NCT04317716
Brief Title
A Self-management Program to Prevent Falls in People With Multiple Sclerosis
Official Title
A Self-management Program to Prevent Falls in Ambulatory and Non-ambulatory Community Dwelling People With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 11, 2022 (Actual)
Primary Completion Date
August 17, 2022 (Actual)
Study Completion Date
August 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Forte, The Swedish Research Council
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
The program will be developed in a co-design process with people with multiple sclerosis and health professionals and evaluated in a feasibility study. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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 online. Control-group participants will receive a brochure about falls and fall risk factors, sent by mail. Baseline and follow-up assessments will be performed by blinded evaluators.
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Fall prevention program and brochure about falls and fall risk factors
Arm Title
Control
Arm Type
Other
Arm Description
Bbrochure about falls and fall risk factors
Intervention Type
Behavioral
Intervention Name(s)
fall prevention program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Brochure about falls and fall risk factors
Intervention Description
Control-group participants will receive a brochure about fall risk factors and fall prevention in addition to the standard MS care and rehabilitation.
Primary Outcome Measure Information:
Title
Fall Prevention Strategy Survey
Description
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
Time Frame
Change from baseline in number of strategies used at 18 weeks after the start of the intervention/control period
Title
Fall Prevention Strategy Survey
Description
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
Time Frame
Number of strategies used at 18 weeks after the start of the intervention/control period
Secondary Outcome Measure Information:
Title
Falls incidence
Description
Falls will be monitored via an online short message service (SMS) and interview
Time Frame
Weekly from baseline to the 18-week follow-up
Title
Measure of fear of falling
Description
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
Time Frame
At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period
Title
Falls Efficacy Scale -International
Description
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
Time Frame
At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period
Title
Spinal Cord Injury Fall Concern Scale
Description
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
Time Frame
At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period
Title
Multiple Sclerosis Impact Scale
Description
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
Time Frame
At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period
Title
Frenchay Activities Index
Description
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).
Time Frame
At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Academic Specialist Centre of Neurology
City
Stockholm
Country
Sweden
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35803627
Citation
Kierkegaard M, Peterson E, Tuvemo Johnson S, Gottberg K, Johansson S, Elf M, Flink M, Ytterberg C. Online self-management fall prevention intervention for people with multiple sclerosis: a feasibility study protocol of a parallel group randomised trial. BMJ Open. 2022 Jul 8;12(7):e061325. doi: 10.1136/bmjopen-2022-061325.
Results Reference
derived
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A Self-management Program to Prevent Falls in People With Multiple Sclerosis
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