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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-11

Study Completion Date

2022-08-17

Brief Summary

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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.

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Detailed Description

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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

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be stratified for ambulation level (ambulatory/non-ambulatory) and a 1:1 allocation ratio of blocks of 4 will be used.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

The facilitators of the fall prevention program will not be involved in the usual care of the participants. The intervention will take place online. Control-group participants will receive a brochure about falls and fall risk factors, sent by mail. Baseline and follow-up assessments will be performed by blinded evaluators.

Study Groups

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Intervention

Fall prevention program and brochure about falls and fall risk factors

Group Type EXPERIMENTAL

fall prevention program

Intervention Type BEHAVIORAL

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.

Control

Bbrochure about falls and fall risk factors

Group Type OTHER

Brochure about falls and fall risk factors

Intervention Type OTHER

Control-group participants will receive a brochure about fall risk factors and fall prevention in addition to the standard MS care and rehabilitation.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No