Evaluation of a Self-management Program to Prevent Falls in People With Multiple Sclerosis

NCT05789225 | Completed DMC

• 1 other identifier: 2022-02553
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled trial is to evaluate the effects of a digital group based self-management fall prevention program, "Fewer Falls in MS", in people with multiple sclerosis (PwMS). The main questions it aims to answer are:.

• Is the Fewer falls in MS program effective in reducing fall incidence in PwMS at 6 and 12 months after start of intervention?
• Does the program have an effect on secondary outcomes at 3, 6 and 12 months?
• How do process evaluation components (context, implementation, mechanisms of impact) inform interpretation of outcomes?
• What is the cost effectiveness of the fall prevention program 12 months after start of intervention? Participants in the intervention group will participate in a group-based self-management fall prevention intervention of eight 2-hour sessions delivered online by a group leader. The group leader will participate in an online education program before intervention start. Home assignments are completed by the participants between group sessions. Participants in the intervention group and the control group will receive a brochure on fall risk factors and fall prevention Researchers will compare the intervention group and the control group to see if there are any differences in fall incidence, sense of control of falls prevention, fear of falling, falls self-efficacy, activity curtailment, perceived impact of MS, self-reported health, and health economic costs. Researchers will also study factors and mechanisms that support or hinder how the fall prevention program builds participants' ability to manage their fall risk; and if and how PwMS have implemented and use self-management fall prevention behaviours into their daily lives.

Conditions

Multiple Sclerosis

Keywords

Self-management; Accidental Falls; Health Economics; Randomized Controlled Trial; Complex Intervention; Process Evaluation; Group-based; Online Intervention; Short Message Service

Outcome Measures

Primary Outcomes (1)

• Falls incidence

  Falls will be monitored weekly via an online short message service. A lower number of falls means a better outcome

  6 and 12-months after start of intervention

Secondary Outcomes (8)

• Falls Control Scale

  3, 6 and 12-months after start of intervention

• Measure of fear of falling

  3, 6 and 12-months after start of intervention

• Falls Efficacy Scale-International

  3, 6 and 12-months after start of intervention

• Spinal Cord Injury Fall Concern Scale

  3, 6 and 12-months after start of intervention

• Revised version of the Short Falls Efficacy Scale-International

  3, 6 and 12-months after start of intervention

Study Arms (2)

Fall prevention program + brochure

EXPERIMENTAL

Fall prevention program and brochure about falls and fall risk factors

Behavioral: Fall prevention program

Brochure

ACTIVE COMPARATOR

Brochure about falls and fall risk factors

Other: Brochure

Interventions

Fall prevention program BEHAVIORAL

The intervention consists of the fall prevention program for ambulatory and non-ambulatory people with multiple sclerosis. The program is group-based with 8 participants in each group, led by a facilitator, and performed online. It comprises seven two-hour sessions held once a week, and a booster session held four weeks after the seventh session. In addition participants will receive a brochure about falls and fall risk factors.

Fall prevention program + brochure

Brochure OTHER

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

Brochure

Eligibility Criteria

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

You may qualify if:

• PwMS aged ≥ 18 years
• Able to walk or 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
• Self-rated ability to use and access to technical devices for online meetings i.e., computers or tablets with internet access and mobile phones to receive and send short message service

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Huddinge, Sweden

Location

Related Publications (5)

• 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 BACKGROUND

• 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, Gottberg K, Walker Peterson E, Meijer U, Bylinder J, Kierkegaard M, Ytterberg C. Effectiveness of Fewer Falls, an online group-based self-management fall prevention programme for people with multiple sclerosis: protocol of a randomised controlled trial. BMJ Open. 2025 Jan 6;15(1):e089217. doi: 10.1136/bmjopen-2024-089217.

  PMID: 39762097 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

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 Officials

• Charlotte Ytterberg, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: March 4, 2023
• First Posted: March 29, 2023
• Study Start: February 8, 2024
• Primary Completion: November 15, 2025
• Study Completion: November 15, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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 (1)