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

CompletedNot a drug-phase studyMS (type not specified)NCT05789225

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Fall prevention programme

Compared with

  • Leaflet

What it measured

Main measures

  • Fall rate

    6 and 12-months after start of intervention

    Walking and mobility

Other measures (8)

  • Falls Control Scale

    3, 6 and 12-months after start of intervention

    Walking and mobility
  • 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

    Walking and mobility
  • Spinal Cord Injury Fall Concern Scale

    3, 6 and 12-months after start of intervention

    Walking and mobility
  • Mobility Inclusive Short Falls Efficacy Scale-International

    3, 6 and 12-months after start of intervention

    Walking and mobility
  • Activity curtailment

    3, 6 and 12-months after start of intervention

  • Multiple Sclerosis Impact Scale

    3, 6 and 12-months after start of intervention

  • EuroQol-5D-5L

    3, 6 and 12-months after start of intervention

    Walking and mobilityPainMood and sleepQuality of life (reported by participants)

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

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

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

History

    1. Started

      Feb 2024

    2. Main results due

      Nov 2025

    3. Finished

      Nov 2025

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