Clinical trial NCT04317716: A Self-management Program to Prevent Falls in People With Multiple Sclerosis
Official title: A Self-management Program to Prevent Falls in Ambulatory and Non-ambulatory Community Dwelling People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Feasibility Studies
Accidental Falls
Self-management
Complex Intervention
Group-based
Online Intervention
Short Message Service
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Forte
name: The Swedish Research Council
First posted: 2020-03-23
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be stratified for ambulation level (ambulatory/non-ambulatory) and a 1:1 allocation ratio of blocks of 4 will be used.
Primary purpose: PREVENTION

Brief summary: This project's overall aim is to develop, deliver, and evaluate feasibility of a fall prevention program for ambulatory and non-ambulatory people with multiple sclerosis. The program will use a comprehensive intervention approach to address a variety of fall risk factors, and utilise self-management strategies. Specific aims are to

1. develop a fall prevention program, that addresses diverse fall risk factors and utilises self-management strategies, for ambulatory and non-ambulatory people with multiple sclerosis using a co-design process.
2. To examine feasibility, acceptability, fidelity, and potential outcome of the online, co-designed self-management fall prevention intervention for ambulatory and non-ambulatory people with multiple sclerosis, and to examine feasibility of the recruitment process, the data collection procedures, and the outcome measures.

Detailed description: Falls among people with multiple sclerosis (PwMS) are common and associated with injuries, fear of falling and low health-related quality of life. Considerations of behavioural, environmental, psychological and physical influences (including ambulation status) are needed to meet fall prevention needs for PwMS. Thus, using a codesign process involving key stakeholders a novel online self-management fall prevention intervention will be created specifically for ambulatory and non-ambulatory PwMS.

The feasibility, acceptability, fidelity and outcome of this complex intervention will be explored. Findings will inform a future full-scale randomised controlled trial. A mixed-method design will be used. Forty-eight PwMS, stratified for ambulation level, will be randomised to control (n=24) or intervention (n=24). Both groups will receive a brochure about fall risk factors and fall prevention. The intervention is group-based (eight PwMS in each group); will be delivered online; and involve six, 2-hour weekly sessions and a booster session 8 weeks after the sixth session. Each intervention group will be led by a trained facilitator.

Data collection will be performed at baseline, and after seven and 18 weeks. Outcome measures will capture data on fall prevention behaviours, fear of falling, falls self-efficacy, social and everyday activities, perceived impact of MS and number of falls. Feasibility of recruitment process, data collection procedures, outcome measures, and delivery, and intervention acceptability, fidelity and outcomes will be evaluated. Both quantitative and qualitative methods will be used.

Eligibility criteria: Inclusion Criteria:

* Community-dwelling adults aged ≥ 18 years
* Diagnosed with multiple sclerosis
* Able to independently transfer from bed to wheelchair with or without aids but without assistance of another person
* Able to understand and communicate in Swedish
* Able to use and access to technical devices for online meetings i.e., computers or tablets with internet access

Primary outcomes:
measure: Fall Prevention Strategy Survey
timeFrame: Change from baseline in number of strategies used at 18 weeks after the start of the intervention/control period
measure: Fall Prevention Strategy Survey
timeFrame: Number of strategies used at 18 weeks after the start of the intervention/control period
Secondary outcomes:
measure: Falls incidence
timeFrame: Weekly from baseline to the 18-week follow-up
measure: Measure of fear of falling
timeFrame: At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period
measure: Falls Efficacy Scale -International
timeFrame: At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period
measure: Spinal Cord Injury Fall Concern Scale
timeFrame: At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period
measure: Multiple Sclerosis Impact Scale
timeFrame: At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period
measure: Frenchay Activities Index
timeFrame: At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Academic Specialist Centre of Neurology
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.