A Self-management Program to Prevent Falls in People With Multiple Sclerosis

NCT04317716 | Completed DMC

• 1 other identifier: 2019-00457
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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

1. 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.
2. 2.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.

Conditions

Multiple Sclerosis

Keywords

Feasibility Studies; Accidental Falls; Self-management; Complex Intervention; Group-based; Online Intervention; Short Message Service

Outcome Measures

Primary Outcomes (2)

• 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

  Change from baseline in number of strategies used at 18 weeks after the start of the intervention/control period

• 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

  Number of strategies used at 18 weeks after the start of the intervention/control period

Secondary Outcomes (6)

• Falls incidence

  Weekly from baseline to the 18-week follow-up

• Measure of fear of falling

  At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period

• Falls Efficacy Scale -International

  At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period

• Spinal Cord Injury Fall Concern Scale

  At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period

• Multiple Sclerosis Impact Scale

  At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period

Study Arms (2)

Intervention

EXPERIMENTAL

Fall prevention program and brochure about falls and fall risk factors

Behavioral: fall prevention program

Control

OTHER

Bbrochure about falls and fall risk factors

Other: Brochure about falls and fall risk factors

Interventions

fall prevention program BEHAVIORAL

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

Brochure about falls and fall risk factors OTHER

Control-group participants will receive a brochure about fall risk factors and fall prevention in addition to the standard MS care and rehabilitation.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Forte: collaborator
• The Swedish Research Council: collaborator

Study Sites (2)

Academic Specialist Centre of Neurology

Stockholm, Sweden

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Related Publications (4)

• 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.

  PMID: 35803627 BACKGROUND

• Tuvemo Johnson S, Flink M, Peterson E, Gottberg K, Elf M, Johansson S, Kierkegaard M, Ytterberg C. Self-management of falls in people with multiple sclerosis: A scoping review. Clin Rehabil. 2023 Feb;37(2):162-176. doi: 10.1177/02692155221128723. Epub 2022 Sep 29.

  PMID: 36177511 RESULT

• Meijer U, Flink M, Tuvemo Johnson S, Kierkegaard M, Gottberg K, Ytterberg C. Preventing falls in multiple sclerosis: a qualitative study on user requirements for a self-management programme. Disabil Rehabil. 2025 Jan;47(2):398-405. doi: 10.1080/09638288.2024.2348725. Epub 2024 May 7.

  PMID: 38711397 RESULT

• Johnson ST, Ytterberg C, Peterson E, Johansson S, Kierkegaard M, Gottberg K, Flink M. Development of Fewer Falls in MS-An Online, Theory-Based, Fall Prevention Self-Management Programme for People With Multiple Sclerosis. Health Expect. 2024 Aug;27(4):e14154. doi: 10.1111/hex.14154.

  PMID: 39032151 RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor (docent)

Model Details: Participants will be stratified for ambulation level (ambulatory/non-ambulatory) and a 1:1 allocation ratio of blocks of 4 will be used.

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: March 23, 2020
• Study Start: February 11, 2022
• Primary Completion: August 17, 2022
• Study Completion: August 17, 2022
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Immediately following publication and ending two years after publication
• Access Criteria: Since data can indirectly be traced back to the study participants, according to the Swedish and EU personal data sharing legislation, access can only be granted upon request. Request for access to the data can be put to our Research Data Office (rdo@ki.se) at Karolinska Institutet, and will be handled according to the relevant legislation. In most cases, this will require a data processing agreement or similar with the recipient of the data.

Locations

SE (2)