Evaluation of a Self-management Program to Prevent Falls in People With Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fall prevention program
Brochure
Sponsored by
About this trial
This is an interventional prevention trial for Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria: Community-dwelling adults Able to 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 Ability to use and access to technical devices for online meetings i.e., computers or tablets with internet access.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Fall prevention program + brochure
Brochure
Arm Description
Fall prevention program and brochure about falls and fall risk factors
Brochure about falls and fall risk factors
Outcomes
Primary Outcome Measures
Falls incidence
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
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
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
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).
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05789225
Brief Title
Evaluation of a Self-management Program to Prevent Falls in People With Multiple Sclerosis
Official Title
Evaluation of a Self-management Program to Prevent Falls in Ambulatory and Non-ambulatory People With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
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
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:
Is the fall prevention program effective in reducing number of falls in PwMS at 6- and 12-months post-intervention?
What 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 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.
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 8 will be used for randomization.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
208 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fall prevention program + brochure
Arm Type
Experimental
Arm Description
Fall prevention program and brochure about falls and fall risk factors
Arm Title
Brochure
Arm Type
Other
Arm Description
Brochure 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 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.
Intervention Type
Other
Intervention Name(s)
Brochure
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
Falls incidence
Description
Falls will be monitored weekly via an online short message service. A lower number of falls means a better outcome
Time Frame
12-months post-intervention
Secondary 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 i.e., a higher score, indicates a better outcome
Time Frame
12-months post-intervention
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
12-months post-intervention
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
12-months post-intervention
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
12-months post-intervention
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
12-months post-intervention
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
12-months post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Community-dwelling adults
Able to 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
Ability to use and access to technical devices for online meetings i.e., computers or tablets with internet access.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charlotte Ytterberg, PhD
Phone
+46702721984
Email
charlotte.ytterberg@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlotte Y Ytterberg, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of a Self-management Program to Prevent Falls in People With Multiple Sclerosis
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