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

NCT01885962 | Completed

• 2 other identifiers: 1540910-175
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury; Pressure Ulcers

Keywords

pressure ulcer prevention; spinal cord injury; internet delivered pressure ulcer intervention

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and 42 Days

Study Arms (2)

Treatment as Usual (TAU)

NO INTERVENTION

Participants in this group engage in typical rehabilitation and perform usual skin care routine.

TAU + iSHIFTup

EXPERIMENTAL

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

Interventions

iSHIFTup BEHAVIORAL

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

TAU + iSHIFTup

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

Woodrow Wilson Rehabilitation Center

Fishersville, Virginia, 22939, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Pressure Ulcer

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lee M Ritterband, PhD

  University of Virginia, Behavioral Health & Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 18, 2013
• First Posted: June 25, 2013
• Study Start: May 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: April 11, 2014

Record last verified: 2014-04

Locations

US (1)