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

NCT05789225 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-04-07

No results posted yet for this study

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

Interventions

BEHAVIORAL

Fall prevention program

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.

OTHER

Brochure

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

Sponsors & Collaborators

Principal Investigators

  • Charlotte Ytterberg, PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-08
Primary Completion
2025-11-15
Completion
2025-11-15

Countries

  • Sweden

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05789225 on ClinicalTrials.gov