Development and Feasibility of an Internet Intervention for Adults With Spinal Cord Injury to Prevent Pressure Ulcers
| Status: | Completed |
|---|---|
| Conditions: | Skin and Soft Tissue Infections, Hospital, Orthopedic, Gastrointestinal |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Gastroenterology, Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/3/2014 |
| Start Date: | May 2012 |
| End Date: | June 2013 |
| Contact: | Lee M Ritterband, PhD |
| Email: | LR5B@hscmail.mcc.virginia.edu |
| Phone: | 434-924-5988 |
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.
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.
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.
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