Pressure Ulcer Prevention for SCI Using a Tele Home Program

Spinal Cord Injury Clinical Trial

— TELEPUPPS  

Official title:

Pressure Ulcer Prevention for SCI Using a Tele Home Program

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01166828
• Other study ID #: NRI 09-110
• Secondary ID: 1 I01 HX000161-0
• Status: Withdrawn
• Phase: N/A
• First received: July 19, 2010
• Last updated: June 25, 2015
• Start date: January 2011
• Est. completion date: May 2014

Study information

• Verified date: June 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• TELLEPUPPS
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.

Locations

Country	Name	City	State
United States	North Florida/South Georgia Veterans Health System	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure ulcer prevention		9 months	No
Secondary	Depression		9 months	No
Secondary	Costs		9 months	No