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Clinical Trials/NCT05789225
NCT05789225Active, not recruitingNot Applicable

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

Karolinska Institutet1 site in 1 country208 target enrollmentStarted: February 8, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
208
Locations
1
Primary Endpoint
Falls incidence

Study Overview

Brief Summary

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

  • Is the Fewer falls in MS program effective in reducing fall incidence 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 brochure 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 incidence, 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.

Detailed Description

Purpose and aims The overall purpose is to evaluate an online fall prevention programme for ambulatory and non-ambulatory people with multiple sclerosis (PwMS). The programme incorporates key features of self-management and addresses a variety of fall risk factors. The effects of the programme in decreasing number of falls will be evaluated in a full scale randomised controlled trial (RCT). The hypothesis is that after participating in the programme, PwMS will identify and self-manage risk factors for falls in their everyday life while taking the daily fluctuations of multiple sclerosis (MS) into consideration (i.e., develop fall prevention behaviours), and thereby reduce the number of falls.

Aims:

  1. To determine if the fall prevention programme is effective in reducing falls in PwMS 6 and 12 months after start of intervention.
  2. To determine if the program has an effect on secondary outcomes at 3, 6 and 12 months.
  3. To explore how process evaluation components (context, implementation, mechanisms of impact) inform interpretation of outcomes.
  4. To evaluate the cost effectiveness of the fall prevention program at 12 months after start of intervention.

INTRODUCTION MS is a chronic inflammatory, demyelinating, and neurodegenerative disease with a global prevalence of about 36 per 100,000 population. The prevalence in women is two to four times higher than in men and the usual onset is between 20 and 40 years of age. The disease is typically progressive in nature with consequences that include an increased risk for falls. Up to 71% of PwMS fall each six months (1). Those who report a fall in the past year have an 82% probability of falling again in the six months after a fall and a 56% probability of sustaining an injurious fall (1). Falls among PwMS are associated with injuries, fear of falling and low health-related quality of life (2).

Several consequences of MS are known fall risk factors for this population, including impaired balance, reduced walking speed, and impaired cognition (2). The lack of attention given to behavioural and environmental influences on fall risk for PwMS is a major gap in existing evidence. Another major gap in MS falls research is that few studies have explored influences on fall risk among individuals who are non-ambulatory, i.e., only capable of walking a few steps or not at all (3). Furthermore, most interventions aiming to prevent falls among PwMS have excluded non-ambulatory individuals. To date, only two research teams are addressing the fall prevention needs of non-ambulatory PwMS: ours and a team based in the U.S. (4). The importance of targeting a variety of modifiable risk factors through fall prevention programs for PwMS has been highlighted (5). The need for comprehensive approaches to fall prevention that address physical, environmental, and behavioural aspects of falls management has been echoed by Gunn et al (6). Despite the recognition of the value of attention to diverse influences on fall risk, most fall prevention interventions for PwMS focus only on addressing physical impairments, such as compromised balance.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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 provided

Arms & Interventions

Fall prevention program + brochure

Experimental

Fall prevention program and brochure about falls and fall risk factors

Intervention: Fall prevention program (Behavioral)

Brochure

Active Comparator

Brochure about falls and fall risk factors

Intervention: Brochure (Other)

Outcomes

Primary Outcomes

Falls incidence

Time Frame: 6 and 12-months after start of intervention

Falls will be monitored weekly via an online short message service. A lower number of falls means a better outcome

Secondary Outcomes

  • Falls Efficacy Scale-International(3, 6 and 12-months after start of intervention)
  • Activity curtailment(3, 6 and 12-months after start of intervention)
  • Multiple Sclerosis Impact Scale(3, 6 and 12-months after start of intervention)
  • Measure of fear of falling(3, 6 and 12-months after start of intervention)
  • EuroQol-5D-5L(3, 6 and 12-months after start of intervention)
  • Spinal Cord Injury Fall Concern Scale(3, 6 and 12-months after start of intervention)
  • Revised version of the Short Falls Efficacy Scale-International(3, 6 and 12-months after start of intervention)
  • Falls Control Scale(3, 6 and 12-months after start of intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Charlotte Ytterberg

Lecturer, associate professor (docent)

Karolinska Institutet

Study Sites (1)

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