search
Back to results

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
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 4, 2023
    Last Updated
    March 28, 2023
    Sponsor
    Karolinska Institutet
    search

    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

    We'll reach out to this number within 24 hrs