NCT04317716

A Self-management Program to Prevent Falls in People With Multiple Sclerosis

A Self-management Program to Prevent Falls in Ambulatory and Non-ambulatory Community Dwelling People With Multiple Sclerosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
BEHAVIORAL	fall prevention program	The intervention consists of the fall prevention program for ambulatory and non-ambulatory people with multiple sclerosis. The program will be group-based with 6-8 participants, led by a facilitator, and performed online. It comprises six two-hour sessions held once a week, and a booster session held eight weeks after the sixth session. In addition they will receive a brochure about falls and fall risk factors.
OTHER	Brochure about falls and fall risk factors	Control-group participants will receive a brochure about fall risk factors and fall prevention in addition to the standard MS care and rehabilitation.

Timeline

• Start date: 2022-02-11
• Primary completion: 2022-08-17
• Completion: 2022-08-17
• First posted: 2020-03-23
• Last updated: 2026-03-27

Locations

2 sites across 1 country: Sweden