Pressure Ulcer Prevention for SCI Using a Tele Home Program

NCT01166828 | Withdrawn DMC

• 2 other identifiers: NRI 09-1101 I01 HX000161-01A1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury; Pressure Ulcers

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pressure ulcer prevention

  9 months

Secondary Outcomes (2)

• Depression

  9 months

• Costs

  9 months

Study Arms (2)

1

EXPERIMENTAL

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.

Behavioral: TELLEPUPPS

2

ACTIVE COMPARATOR

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

Behavioral: TELLEPUPPS

Interventions

TELLEPUPPS BEHAVIORAL

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.

1; 2

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

North Florida/South Georgia Veterans Health System

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Pressure Ulcer

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Joyce K. Stechmiller, PhD MSN BSN

  North Florida/South Georgia Veterans Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: July 19, 2010
• First Posted: July 21, 2010
• Study Start: January 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 26, 2015

Record last verified: 2015-06

Locations

US (1)