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

University of Virginia

Status: Completed

Conditions: Pressure Ulcers; Spinal Cord Injury

Treatments: Behavioral: iSHIFTup

Study type: Interventional

Funder types: Other

Identifiers

NCT01885962

15409

10-175 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Treatment as Usual (TAU)

No Intervention group

Description:

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

TAU + iSHIFTup

Experimental group

Description:

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.

Treatment:

Behavioral: iSHIFTup