An interventional study of iSHIFTup in Spinal Cord Injury and Pressure Ulcers, sponsored by University of Virginia. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-11.
Sponsored by University of Virginia · Not applicable, Interventional, and Prevention
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.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 19 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
SCI of non-traumatic etiology such as:
Participants in this group engage in typical rehabilitation and perform usual skin care routine.
Participants in this group engage in typical rehabilitation and use iSHIFTup, Internet Skin Health Intervention for Targeted Ulcer Prevention. Participants are instructed to perform program recommendations to engage in preventive skin care behaviors.
Behavioral: iSHIFTup
Internet-delivered program to support behaviors to prevent pressure ulcers and promote healthy skin in adults with spinal cord injury.
Also known as: iSHIFTup, Internet Skin Health Intervention for Targeted Ulcer Prevention
Retrospective Diary Data
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.
Time frame: Baseline and 42 days
Needs Assessment Checklist (Skin Management Subscale)
Participants complete the NAC-SM after enrollment and again 42 days later. Change in NAC-SM scores from baseline to 42 days is measured.
Time frame: Baseline and 42 Days
This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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University of Virginia