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

June 25, 2015 updated by: US Department of Veterans Affairs
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

17 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
Active Comparator: 2
TAC participants will have six phone contacts every other week for three months.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Pressure ulcer prevention
Time Frame: 9 months
9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Depression
Time Frame: 9 months
9 months
Costs
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
US Department of Veterans Affairs

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joyce K. Stechmiller, PhD MSN BSN, North Florida/South Georgia Veterans Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2014

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 26, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NRI 09-110
  • 1 I01 HX000161-01A1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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