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

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ClinicalTrials.gov Identifier: NCT01885962
Recruitment Status : Completed
First Posted : June 25, 2013
Last Update Posted : April 11, 2014
Sponsor:
Information provided by (Responsible Party):
Lee M Ritterband, University of Virginia

Brief 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.


Condition or disease Intervention/treatment Phase
Spinal Cord Injury Pressure Ulcers Behavioral: iSHIFTup Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Development and Feasibility of an Internet Intervention for Adults With Spinal Cord Injury to Prevent Pressure Ulcers
Study Start Date : May 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.



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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01885962


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

Additional Information:
Responsible Party: Lee M Ritterband, Associate Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT01885962     History of Changes
Other Study ID Numbers: 15409
10-175 ( Other Grant/Funding Number: Virginia Commonwealth Neurotrauma Initiative )
First Posted: June 25, 2013    Key Record Dates
Last Update Posted: April 11, 2014
Last Verified: April 2014

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

Additional relevant MeSH terms:
Pressure Ulcer
Wounds and Injuries
Ulcer
Spinal Cord Injuries
Pathologic Processes
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Skin Ulcer
Skin Diseases