ClinicalTrials.gg
WithdrawnNCT01166828TELEPUPPSUpdated Jun 26, 2015

Pressure Ulcer Prevention for SCI Using a Tele Home Program

An interventional study of TELLEPUPPS in Spinal Cord Injury and Pressure Ulcers, sponsored by US Department of Veterans Affairs. Withdrawn at 1 site in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-06-26.

Sponsored by US Department of Veterans Affairs · Not applicable, Interventional, and Prevention

Why this study was withdrawn
Project not funded - withdrawn by VA
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
21 Years to 80 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Spinal Cord Injury
  • Pressure Ulcers

Keywords

  • Spinal cord injury
  • telehealth
  • pressure ulcers
  • quality of life
03

In context

Spinal Cord Injuries

1,988 studies on the registry are indexed under Spinal Cord Injuries; 516 are open to participants now.

Browse Spinal Cord Injuries studies →

Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 675 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
0 participants (actual)

Study arms

  • Experimental
    1

    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

  • Active comparator
    2

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

    Behavioral: TELLEPUPPS

Interventions

  • BehavioralTELLEPUPPS

    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.

06

What researchers measure

Primary outcomes

  1. Pressure ulcer prevention

    Time frame: 9 months

Secondary outcomes

  1. Depression

    Time frame: 9 months

  2. Costs

    Time frame: 9 months

07

Study locations

1 site
  • North Florida/South Georgia Veterans Health System
    Gainesville, Florida 32608, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2011, a primary completion of Jan 2014 and a completion of May 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 19, 2010
First posted
Jul 21, 2010
Start
Jan 2011
Primary completionEst.
Jan 2014
CompletionEst.
May 2014
Last update
Jun 26, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01166828
First posted
Jul 21, 2010
Start date
Jan 2011
Primary completion
Jan 2014 (estimated)
Completion
May 2014 (estimated)
Last update
Jun 26, 2015

Study contacts

Joyce K. Stechmiller, PhD MSN BSN
principal investigator · North Florida/South Georgia Veterans Health System

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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