Development and Validation of a mHealth Fall Management Program - Phase III
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Transfer Assessment Instrument Questionnaire
研究概览
简要总结
The research team is conducting a study to determine if a fall prevention program designed specifically for people who use wheelchairs and scooters can help people better prevent and manage falls compared to the standard of care.
This study will compare two groups of participants:
- One group will use the iROLL-O+ app, which offers personalized fall prevention tools and strategies.
- The other group will receive fall prevention information from a well-known program developed by the Centers for Disease Control and Prevention (CDC), called STEADI, which stands for Stopping Elderly Accidents, Deaths, and Injuries.
This study includes adults living with Spinal Cord Injury (SCI) or Multiple Sclerosis (MS) who use a wheelchair or scooter every day. The research team aims to determine which approach is more effective in reducing falls and improving confidence in performing daily activities.
详细描述
People living with SCI or MS who use wheelchairs and scooters (WC/S) full time often experience falls. In fact, 7 out of 10 report falling at least once every 6 to 12 months. These falls can lead to serious injuries and emotional distress, such as concerns about falling (CaF). Although falls are common among this population, most fall prevention programs are designed for people who can walk. There are very few programs designed for people who use WC/S.
This study will test to see if a fall prevention and management program designed specifically for people who use WC/S does a better job at helping people learn how to prevent and manage falls compared to a program that is designed for older adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
Participants will be blindly assigned to one of the groups to reduce bias.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or older.
- •History of Multiple Sclerosis (MS) or Spinal Cord Injury (SCI).
- •Able to transfer independently or with minimal to moderate assistance.
- •Unable to walk 25 feet or more
- •Have experienced at least 1 fall in the past three years.
- •Have a care partner to assist the participant when practicing physical skills.
- •Have access to a smartphone/iPad.
- •Have a stable internet connection.
排除标准
- •Multiple sclerosis exacerbation in the past 30 days, or are unable to remain in an upright position for an hour.
- •Impaired cognition (a score of 10 or above on the Short Blessed Test).
研究组 & 干预措施
Individualized reduction of falls (iROLL) Group
iROLL group participants will be educated about fall prevention and management strategies using the individualized reduction of falls (iROLL) mobile application (app)
干预措施: Individualized reduction of falls (iROLL) (Procedure)
Stopping Elderly Accidents, Deaths & Injuries (STEADI) Program Group
STEADI group participants will be educated about fall prevention and management strategies using Centers for Disease Control and Prevention entitled: Stopping Elderly Accidents, Deaths & Injuries (STEADI) program.
干预措施: Stopping Elderly Accidents, Deaths & Injuries (STEADI) (Procedure)
结局指标
主要结局
Transfer Assessment Instrument Questionnaire
时间窗: Baseline, Post-Intervention (Week 6 and Week 14)
Measures participants' safety, technique, and confidence when transferring between surfaces (e.g., wheelchair to bed).
Functional Assessment of Currently Employed Technology Scale
时间窗: Baseline
Assesses how individuals with disabilities utilize currently available and assistive technologies in their everyday lives across five functional domains (Home, Social, E-commerce, Health Care, Technical). Subscale (Domain) Scoring: Each domain's subtotal ranges from 0 to 10. Higher scores indicate more frequent use of technology. Interpretation categories: 0-2: Very Infrequent IT Use; 3-4: Infrequent IT Use; 5-6: Moderate IT Use; 7-8: Frequent IT Use; 9-10: Very Frequent IT Use Total FACETS Score: Ranges from 0 to 50 (sum of the five domain subtotals). Higher total scores = greater overall frequency of technology use. Interpretation categories: 0-14: Very Infrequent IT Use; 15-24: Infrequent IT Use; 25-34: Moderate IT Use; 35-44: Frequent IT Use; 45-50: Very Frequent IT Use
Fall Concerns Scale for Wheelchair and Scooter Users
时间窗: Baseline, Post-Intervention (Week 6 and Week 14)
Measures fear of falling and fall-related self-efficacy in individuals who use wheelchairs or scooters. The Fall Concerns Scale for Wheelchair and Scooter Users consists of 16 items, each rated on a 4-point Likert scale (1 = "not at all concerned" to 4 = "very concerned"). The total score ranges from 16 to 64, with higher scores indicating greater fear of falling and lower fall-related self-efficacy.
Falls Prevention Strategies Survey
时间窗: Baseline, Post-Intervention (Week 6 and Week 14)
Captures the frequency and types of fall prevention behaviors or strategies participants use in their daily lives.
The Fall Management Scale
时间窗: Baseline, Post-Intervention (Week 6 and Week 14)
Assesses participant confidence and preparedness in managing fall-related scenarios (e.g., recovery techniques, communication, and safety). Total scores range from 0 to 64. Higher scores indicate greater use of fall management strategies (better outcome).
Fall Prevention and Management Questionnaire
时间窗: Baseline, Post-Intervention (Week 6 and Week 14)
A multi-dimensional tool that evaluates participants' knowledge, behaviors, and attitudes toward fall prevention and recovery.
Community Participation Indicators Questionnaire
时间窗: Baseline, Post-Intervention (Week 6 and Week 14)
A self-report 48-item objective that measures two distinct subsets: 1\) Importance and meaning, and 2) Control over participation. This questionnaire assesses levels of community engagement, social interaction, and participation in everyday activities outside the home. Items are typically rated on a Likert scale and aggregated to produce subscale scores and a total participation score. Higher scores indicate greater community participation. Scores range between 0 and 1, where: 0 = no meaningful participation. 1 = full participation in all important activities
Wheelchair Skills Test - Questionnaire
时间窗: Baseline, Post-Intervention (Week 6 and Week 14)
Self-reported version of the Wheelchair Skills Test assessing wheelchair handling and maneuvering capabilities.
System Usability Scale
时间窗: Post-Intervention (Week 6)
Evaluates participants' perceived usability of the iROLL-O+ mobile app - only for the intervention group. The SUS consists of 10 items, each scored on a 5-point Likert scale (0-4). The total raw score is converted to a 0-100 scale. Higher scores indicate better usability. A score of 68 is considered average usability; scores above 68 reflect above-average usability, while scores below 68 reflect below-average usability.
Usefulness, Satisfaction, and Ease of Use Questionnaire
时间窗: Post-Intervention (Week 6)
Assesses perceived usefulness, satisfaction, and ease of use of a mobile app. - only for the intervention group
Mobile App Rating Scale
时间窗: Post-Intervention (Week 6)
Evaluates mobile app quality, including engagement, functionality, aesthetics, and information content. - Only for the intervention group. The uMARS contains 20 items across four objective quality subscales (Engagement, Functionality, Aesthetics, Information). Each item is rated on a 5-point Likert scale (1-5). Subscale scores are averaged, and a total quality mean score can also be calculated. Higher scores indicate higher app quality.
次要结局
未报告次要终点
研究者
Laura Rice
Associate Professor in the Department of Health and Kinesiology; Associate Head for Graduate Studies; Associate Director of the Center for Health, Aging, and Disability; Principal Investigator
University of Illinois at Urbana-Champaign