A Self-management Program to Prevent Falls in Ambulatory and Non-ambulatory Community Dwelling People With Multiple Sclerosis
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Multiple Sclerosis
- 发起方
- Karolinska Institutet
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Fall Prevention Strategy Survey
- 状态
- 已完成
- 最后更新
- 上个月
概览
简要总结
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
- 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.
- 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.
详细描述
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.
研究者
Charlotte Ytterberg
associate professor (docent)
Karolinska Institutet
入排标准
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Fall Prevention Strategy Survey
时间窗: Number of strategies used at 18 weeks after the start of the intervention/control period
The scale includes 14 fall prevention strategies. Participants report whether they currently use or have used the strategies to manage falls risk. If they are using it, they rate strategy effectiveness on a scale of 0-10. If they are not using it, they identify why (e.g., forgot, didn't think it would work, don't know how). The number of strategies used is calculated where a higher number of strategies indicate a better outcome
Fall Prevention Strategy Survey
时间窗: Change from baseline in number of strategies used at 18 weeks after the start of the intervention/control period
The scale includes 14 fall prevention strategies. Participants report whether they currently use or have used the strategies to manage falls risk. If they are using it, they rate strategy effectiveness on a scale of 0-10. If they are not using it, they identify why (e.g., forgot, didn't think it would work, don't know how). The number of strategies used is calculated where a higher number of strategies indicate a better outcome
次要结局
- Measure of fear of falling(At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period)
- Falls incidence(Weekly from baseline to the 18-week follow-up)
- Spinal Cord Injury Fall Concern Scale(At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period)
- Multiple Sclerosis Impact Scale(At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period)
- Falls Efficacy Scale -International(At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period)
- Frenchay Activities Index(At baseline, and at follow-ups seven and 18 weeks after the start of the intervention/control period)