Development and Feasibility of an Internet Intervention for Adults With Spinal Cord Injury to Prevent Pressure Ulcers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Retrospective Diary Data
研究概览
简要总结
The investigators propose to test the feasibility of iSHIFTup (Internet Skin Health Intervention For Targeted Ulcer Prevention) for adults with spinal cord injury (SCI) to prevent serious pressure ulcers (PrUs) and promote protective health behaviors. This protocol is Phase 2 of a three phase project. In Phase 1, the investigators developed iSHIFTup. In Phase 2, the investigators will test the intervention by partnering with Woodrow Wilson Rehabilitation Center (WWRC) to conduct a randomized controlled trial (RCT) of 18 participants. In Phase 3, the investigators will focus on optimizing the intervention based on our outcome findings and feedback, sustaining the program at WWRC, and seeking future funding for a larger RCT.
The investigators will conduct an RCT of up to 18 participants (9 participants in treatment as usual (TAU) group, 9 participants in TAU + iSHIFTup intervention group) (18 participants are needed to obtain statistically significant results).
The investigators will meet with potential participants in-person to complete the informed consent process and confirm eligibility. Participants in the TAU+iSHIFTup group will use the program during the study period. Participants randomized to TAU will have usual treatment during the study period and an opportunity to use the program following trial participation. The investigators will collect information from participants at two times during the study, at enrollment and post-intervention at 6-weeks (42 days). The investigators will also collect qualitative information from participants in the TAU+iSHIFTup group, during an optional focus-group setting, to learn users' experiences with the program. The investigators expect participants in the TAU+iSHIFTup group as compared to the TAU group, to display greater awareness of personal risk for pressure ulcers; increased preventive behaviors; and increased skin care self-efficacy and knowledge.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 18 years of age
- •history of Traumatic Spinal Cord Injury resulting in paraplegia or tetraplegia.
- •regular Internet access
- •physical ability to use computer
- •able to understand, read and speak English
- •have identified healthcare provider
排除标准
- •SCI of non-traumatic etiology such as:
- •ischemia,
- •developmental disorders,
- •neurodegenerative diseases,
- •demyelinative diseases,
- •transverse myelitis,
- •vascular malformations.
- •Severe pressure ulcer (stage 3 or stage 4).
- •Currently pregnant or plan to become pregnant during the study period.
结局指标
主要结局
Retrospective Diary Data
时间窗: Baseline and 42 days
This measure tracks skin care behaviors. It is completed by participants at enrollment and 42 days later. Change in baseline behaviors from baseline to 42 days is measured.
Needs Assessment Checklist (Skin Management Subscale)
时间窗: Baseline and 42 Days
Participants complete the NAC-SM after enrollment and again 42 days later. Change in NAC-SM scores from baseline to 42 days is measured.
次要结局
未报告次要终点
研究者
Lee M Ritterband
Associate Professor
University of Virginia