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Pressure Ulcer Prevention for SCI Using a Tele Home Program (TELEPUPPS)

Primary Purpose

Spinal Cord Injury, Pressure Ulcers

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TELLEPUPPS
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Cord Injury focused on measuring Spinal cord injury, telehealth, pressure ulcers, quality of life

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Veterans with SCI - at the level of C6-L1 motor complete (ASIA A) 96 who have physical capability of independently performing a "pressure relief" (ASIA A persons are nonambulatory population and thus, full-time wheelchair users and are the most susceptible to having PUs)
  • 21 years of age or older
  • free of PUs for at least six months prior to recruitment
  • SCI for 1 year in duration
  • reside with a caregiver
  • have a " plain old telephone system" (POTS) line in their home of residence

Exclusion Criteria:

  • Veterans with SCI with complete motor and spared sensory function , individuals with lesions C5 and above and lesions below L1
  • significant psychiatric comorbidities (e.g., schizophrenia and other active psychoses)
  • cognitive impairments that limit a patient's ability to participate in the TELEPUPPS or telephone attention control intervention
  • a terminal illness

Sites / Locations

  • North Florida/South Georgia Veterans Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

The TELEPUPPS participants will learn self care management of PUP through a program based on a social cognitive behavioral model to reinforce problem solving and self-efficacy in preventing pressure ulcers.

TAC participants will have six phone contacts every other week for three months.

Outcomes

Primary Outcome Measures

Pressure ulcer prevention

Secondary Outcome Measures

Depression
Costs

Full Information

First Posted
July 19, 2010
Last Updated
June 25, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT01166828
Brief Title
Pressure Ulcer Prevention for SCI Using a Tele Home Program
Acronym
TELEPUPPS
Official Title
Pressure Ulcer Prevention for SCI Using a Tele Home Program
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Project not funded - withdrawn by VA
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
NRI research focuses on nursing interventions that are patient-centered, culturally congruent, cost-effective and outcome-driven. High priority populations of interest are veterans with Spinal Cord Injuries (SCI). The development of innovative tele home techniques for preventing pressure ulcers in veterans with SCI is of high importance in the VA. Our findings may provide clinicians with improved methods for skin and wound assessment and more effective and efficient PUP strategies for Hispanic and non Hispanic veterans. The new model for primary care, the patient-centered Medical Home provides an exciting change in the VA that can benefit from the proposed project.
Detailed Description
The goal of the proposed project is to evaluate outcomes of a telehealth nursing intervention based on a social cognitive behavioral model to promote self management in pressure ulcer prevention, reduce costs and identify barriers and facilitators of using telehealth technology in the home environment. The telehealth intervention links to the Medical Home Model in the areas of providing self-management, patient education and family involvement in the veterans' care at home. NRI research focuses on nursing interventions that are patient-centered, culturally congruent, cost-effective and outcome-driven. Improving SCI care and the quality of life in veterans is a critical component of the VA mission. Veterans with SCI face many secondary complications including pressure ulcers (PU). Although PUs in SCI has been conceptualized as a mechanical alteration in skin integrity, there is ample evidence that supports the presence of a behavioral component to PU development. Based on promising results from our feasibility and validation pilot study, we propose "TELEPUPPS" (TELE pressure ulcer prevention problem solving), a program that innovatively combines two unique and complementary telehealth technologies--wireless tele-technology with camcorders and an in-home messaging device for veterans and their informal caregivers to prevent PUs. The proposed project is a randomized, controlled multi-site trial. The study will be conducted at the NF/SG VHS in Gainesville and Lake City, Florida and the VA Caribbean Healthcare System (VACHS) in San Juan, Puerto Rico. Two hundred and thirty-two Hispanic and non Hispanic white veterans with SCI, caregivers and the absence of a PU for at least six months will be randomly assigned to one of two study arms: (1) TELEPUPPS; or (2) telephone attention control (TAC). Both groups will receive the usual medical care provided by the VA. The TELEPUPPS participants will learn self care management of PUP through a program based on a social cognitive behavioral model to reinforce problem solving and self-efficacy in preventing pressure ulcers. The program has been translated and validated for Puerto Rican veterans using focus groups. The TELEPUPPS participants will receive six TELEPUPPS sessions and the TAC participants will have six phone contacts every other week for three months. All participants will be assessed at baseline (T1), three months (T2), and nine months (T3). Assessments will focus on 1) the study outcomes: PU prevention (Number of PUs and stage of PU), QOL, depression, adherence to self-management strategies for PUP, veteran and caregiver satisfaction, costs, and barriers and facilitators; (2) potential mediating variables: problem solving and self-efficacy; and (3) covariates including demographics and socio economics: age, ethnicity, education, marital status, rural vs. urban, caregiver, income, employment/retired status and health status variables. VA Project

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
Spinal cord injury, telehealth, pressure ulcers, quality of life

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
The TELEPUPPS participants will learn self care management of PUP through a program based on a social cognitive behavioral model to reinforce problem solving and self-efficacy in preventing pressure ulcers.
Arm Title
2
Arm Type
Active Comparator
Arm Description
TAC participants will have six phone contacts every other week for three months.
Intervention Type
Behavioral
Intervention Name(s)
TELLEPUPPS
Intervention Description
The TELEPUPPS participants will learn self care management of PUP through a program based on a social cognitive behavioral model to reinforce problem solving and self-efficacy in preventing pressure ulcers.
Primary Outcome Measure Information:
Title
Pressure ulcer prevention
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Depression
Time Frame
9 months
Title
Costs
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Veterans with SCI - at the level of C6-L1 motor complete (ASIA A) 96 who have physical capability of independently performing a "pressure relief" (ASIA A persons are nonambulatory population and thus, full-time wheelchair users and are the most susceptible to having PUs) 21 years of age or older free of PUs for at least six months prior to recruitment SCI for 1 year in duration reside with a caregiver have a " plain old telephone system" (POTS) line in their home of residence Exclusion Criteria: Veterans with SCI with complete motor and spared sensory function , individuals with lesions C5 and above and lesions below L1 significant psychiatric comorbidities (e.g., schizophrenia and other active psychoses) cognitive impairments that limit a patient's ability to participate in the TELEPUPPS or telephone attention control intervention a terminal illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joyce K. Stechmiller, PhD MSN BSN
Organizational Affiliation
North Florida/South Georgia Veterans Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Florida/South Georgia Veterans Health System
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States

12. IPD Sharing Statement

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Pressure Ulcer Prevention for SCI Using a Tele Home Program

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