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COMPLETED
NCT05789225
NA

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

Sponsor: Karolinska Institutet

View on ClinicalTrials.gov

Summary

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

Official title: Evaluation of a Self-management Program to Prevent Falls in Ambulatory and Non-ambulatory People With Multiple Sclerosis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2024-02-08

Completion Date

2025-11-15

Last Updated

2026-10-15

Healthy Volunteers

No

Interventions

BEHAVIORAL

Fall prevention programme

The intervention consists of the fall prevention programme for ambulatory and non-ambulatory people with multiple sclerosis. The programme is group-based with 8 participants in each group, led by a group leader, 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 leaflet about falls and fall risk factors.

OTHER

Leaflet

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

Locations (1)

Karolinska Institutet

Huddinge, Sweden