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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lee M Ritterband, University of Virginia
ClinicalTrials.gov Identifier:
NCT01885962
First received: June 18, 2013
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Lee M Ritterband, Associate Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT01885962     History of Changes
Other Study ID Numbers: 15409, 10-175
Study First Received: June 18, 2013
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 22, 2014