Development and Feasibility of an Internet Intervention for Adults With Spinal Cord Injury to Prevent Pressure Ulcers (iSHIFTup)
Primary Purpose
Spinal Cord Injury, Pressure Ulcers
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iSHIFTup
Sponsored by
About this trial
This is an interventional prevention trial for Spinal Cord Injury focused on measuring pressure ulcer prevention, spinal cord injury, internet delivered pressure ulcer intervention
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.
Sites / Locations
- Woodrow Wilson Rehabilitation Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Treatment as Usual (TAU)
TAU + iSHIFTup
Arm Description
Participants in this group engage in typical rehabilitation and perform usual skin care routine.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01885962
Brief Title
Development and Feasibility of an Internet Intervention for Adults With Spinal Cord Injury to Prevent Pressure Ulcers
Acronym
iSHIFTup
Official Title
Development and Feasibility of an Internet Intervention for Adults With Spinal Cord Injury to Prevent Pressure Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Pressure Ulcers
Keywords
pressure ulcer prevention, spinal cord injury, internet delivered pressure ulcer intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment as Usual (TAU)
Arm Type
No Intervention
Arm Description
Participants in this group engage in typical rehabilitation and perform usual skin care routine.
Arm Title
TAU + iSHIFTup
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
iSHIFTup
Other Intervention Name(s)
iSHIFTup, Internet Skin Health Intervention for Targeted Ulcer Prevention
Intervention Description
Internet-delivered program to support behaviors to prevent pressure ulcers and promote healthy skin in adults with spinal cord injury.
Primary Outcome Measure Information:
Title
Retrospective Diary Data
Description
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.
Time Frame
Baseline and 42 days
Title
Needs Assessment Checklist (Skin Management Subscale)
Description
Participants complete the NAC-SM after enrollment and again 42 days later. Change in NAC-SM scores from baseline to 42 days is measured.
Time Frame
Baseline and 42 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee M Ritterband, PhD
Organizational Affiliation
University of Virginia, Behavioral Health & Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Woodrow Wilson Rehabilitation Center
City
Fishersville
State/Province
Virginia
ZIP/Postal Code
22939
Country
United States
12. IPD Sharing Statement
Links:
URL
http://ishiftup.org
Description
iSHIFTup Study website
Learn more about this trial
Development and Feasibility of an Internet Intervention for Adults With Spinal Cord Injury to Prevent Pressure Ulcers
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