Clinical trial NCT01885962: Development and Feasibility of an Internet Intervention for Adults With Spinal Cord Injury to Prevent Pressure Ulcers
Official title: Development and Feasibility of an Internet Intervention for Adults With Spinal Cord Injury to Prevent Pressure Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Pressure Ulcers
Keywords: pressure ulcer prevention
spinal cord injury
internet delivered pressure ulcer intervention
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2013-06-25
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Retrospective Diary Data
timeFrame: Baseline and 42 days
measure: Needs Assessment Checklist (Skin Management Subscale)
timeFrame: Baseline and 42 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Fishersville
country: United States
facility: Woodrow Wilson Rehabilitation Center
state: Virginia
Study officials:
affiliation: University of Virginia, Behavioral Health & Technology
name: Lee M Ritterband, PhD
role: PRINCIPAL_INVESTIGATOR
References: