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

Spinal Cord Injury Clinical Trial

— iSHIFTup  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01885962
• Other study ID #: 15409
• Secondary ID: 10-175
• Status: Completed
• Phase: N/A
• First received: June 18, 2013
• Last updated: April 10, 2014
• Start date: May 2012
• Est. completion date: June 2013

Study information

• Verified date: April 2014
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pressure Ulcer
• Pressure Ulcers
• Spinal Cord Injuries
• Spinal Cord Injury
• Ulcer

Intervention

Behavioral:
• iSHIFTup
Internet-delivered program to support behaviors to prevent pressure ulcers and promote healthy skin in adults with spinal cord injury.

Locations

Country	Name	City	State
United States	Woodrow Wilson Rehabilitation Center	Fishersville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No

External Links

•   iSHIFTup Study website