Clinical trial NCT01166828: Pressure Ulcer Prevention for SCI Using a Tele Home Program
Official title: Pressure Ulcer Prevention for SCI Using a Tele Home Program
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Spinal Cord Injury
Pressure Ulcers
Keywords: Spinal cord injury
telehealth
pressure ulcers
quality of life
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-07-21
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Pressure ulcer prevention
timeFrame: 9 months
Secondary outcomes:
measure: Depression
timeFrame: 9 months
measure: Costs
timeFrame: 9 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System
state: Florida
Study officials:
affiliation: North Florida/South Georgia Veterans Health System
name: Joyce K. Stechmiller, PhD MSN BSN
role: PRINCIPAL_INVESTIGATOR
References: