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Development and Feasibility of an Internet Intervention for Adults With Spinal Cord Injury to Prevent Pressure Ulcers (iSHIFTup)

This study has been completed.
Information provided by (Responsible Party):
Lee M Ritterband, University of Virginia Identifier:
First received: June 18, 2013
Last updated: April 10, 2014
Last verified: April 2014

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.

Condition Intervention
Spinal Cord Injury
Pressure Ulcers
Behavioral: iSHIFTup

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Development and Feasibility of an Internet Intervention for Adults With Spinal Cord Injury to Prevent Pressure Ulcers

Resource links provided by NLM:

Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Retrospective Diary Data [ Time Frame: 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) [ Time Frame: 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.

Enrollment: 19
Study Start Date: May 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Treatment as Usual (TAU)
Participants in this group engage in typical rehabilitation and perform usual skin care routine.
Experimental: TAU + iSHIFTup
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.
Other Name: iSHIFTup, Internet Skin Health Intervention for Targeted Ulcer Prevention


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • ≥ 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

Exclusion Criteria:

  • SCI of non-traumatic etiology such as:

    • tumor,
    • 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01885962

United States, Virginia
Woodrow Wilson Rehabilitation Center
Fishersville, Virginia, United States, 22939
Sponsors and Collaborators
University of Virginia
Principal Investigator: Lee M Ritterband, PhD University of Virginia, Behavioral Health & Technology
  More Information

Additional Information:
Responsible Party: Lee M Ritterband, Associate Professor, University of Virginia Identifier: NCT01885962     History of Changes
Other Study ID Numbers: 15409
10-175 ( Other Grant/Funding Number: Virginia Commonwealth Neurotrauma Initiative )
Study First Received: June 18, 2013
Last Updated: April 10, 2014

Keywords provided by University of Virginia:
pressure ulcer prevention
spinal cord injury
internet delivered pressure ulcer intervention

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Pressure Ulcer
Pathologic Processes
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Skin Ulcer
Skin Diseases processed this record on May 24, 2017