NCT05789225Completed
Evaluation of a Self-management Programme to Prevent Falls in People With Multiple Sclerosis
Evaluation of a Self-management Program to Prevent Falls in Ambulatory and Non-ambulatory People With Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 240 (actual)
- First submitted
- 4 Mar 2023
- Start date
- 8 Feb 2024
- Primary completion date
- 15 Nov 2025
- Lead sponsor
- Karolinska Institutet
- Diseases
- Multiple sclerosis
- NCT number
- NCT05789225
What you commit to
- Study type: Interventional
- Participants enrolled: 240
- From 8 Feb 2024 to the primary completion date, 15 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Karolinska Institutet Coordinator of this site? Confirm its status | Huddinge | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.