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NCT01885962 · ClinicalTrials.gov registry record · NA
Development and Feasibility of an Internet Intervention for Adults With Spinal Cord Injury to Prevent Pressure Ulcers
A NA study of Spinal Cord Injury and Pressure Ulcers, sponsored by University of Virginia.
- Completed
- Registry status
- NA
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT01885962: Completed NA study of Spinal Cord Injury and Pressure Ulcers, sponsored by University of Virginia.
NCT01885962 is a NA study of Spinal Cord Injury and Pressure Ulcers that has completed, run by University of Virginia. The registered enrollment target is 19 participants, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01885962, a NA study of Spinal Cord Injury and Pressure Ulcers, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- NA
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL iSHIFTup
Study Locations (1)
Virginia
- Woodrow Wilson Rehabilitation Center - Fishersville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2012-05 |
| Est. Completion | 2013-06 |
| Phase | NA |
What the finished NCT01885962 record still lists
NCT01885962 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 86-participant average among 99 other Spinal Cord Injury trials with a reported enrollment target (78% lower).
The record links to 2 conditions, with Spinal Cord Injury appearing as the primary indexed condition, and to 1 intervention - of which iSHIFTup is the first listed.
NCT01885962 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT01885962 about?
NCT01885962 is a clinical study titled "Development and Feasibility of an Internet Intervention for Adults With Spinal Cord Injury to Prevent Pressure Ulcers". 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 projec...
What is the current status of trial NCT01885962?
This trial is currently completed. It is a NA study. The enrollment target is 19 participants. The study started on 2012-05. Estimated completion is 2013-06.
What conditions does trial NCT01885962 study?
This clinical trial studies the following conditions: Spinal Cord Injury, Pressure Ulcers.
What interventions are being tested in trial NCT01885962?
The interventions under investigation include: iSHIFTup (BEHAVIORAL).
Who is sponsoring clinical trial NCT01885962?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01885962 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01885962's enrollment target sits among peer trials
19 60th of 99 higher than 38 of 99 other Spinal Cord Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spinal Cord Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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