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OpenTrials
Completed

NCT Number: NCT00624806

Developing a Home Telehealth Program to Manage Pressure Ulcers in SCI/D

The Veteran's Health Administration (VHA) is a national leader in using distance technology to monitor patients' self-care via an in-home messaging device with disease management protocols (DMPs). No such DMPs exist for the community dwelling spinal cord injury/disorders (SCI/D) population. Our objective is to develop the tools necessary for implementing a new home telehealth program to manage community-dwelling veterans with SCI/D at high risk of developing pressure ulcers (PrUs).

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Edward Hines Jr. VA Hospital, Hines, IL, Hines, Illinois, United States

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About this study

Background:

VHA is a national leader in using distance technology to monitor patients' self-care via an in-home messaging device with disease management protocols (DMPs). No such DMPs exist for the community dwelling spinal cord injury/disorders (SCI/D) population. Our objective is to develop the tools necessary for implementing a new home telehealth program to manage community-dwelling veterans with SCI/D at high risk of developing pressure ulcers (PrUs).

Objectives:

The goal of the study was to complete activities necessary in preparation for implementing a Home Telehealth program to manage veterans with SCI/D at risk of developing PrUs. Specifically this Rapid Response Project (RRP) included: 1) Convening an expert panel to validate Pressure Ulcer (PrU) PrU DMP items; 2) Developing a standardized protocol that specified how the nurse Care Coordinator who would manage patients who develop open skin wounds across the Hub and Spoke system of care; 3) Assessing individual telehealth DMP items by calling a sample of patients on a daily or weekly basis for up to 2 months to determine their validity and 4) Developing an instrument to assess staff satisfaction with this method of patient management.

Methods:

A convenience sample of veterans about to be discharged home from the Cleveland SCI/D inpatient unit were asked to participate in the study. This included patients living close to the Hub and those referred from spoke sites. Subjects were randomly assigned to receive either daily calls (5 days/week) for 40 total calls, or weekly calls (8 total calls) over the course of the 8 week/2month study intervention period.

Status:

The project team is conducting ongoing analysis of the data to develop publications.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Veterans admitted to Cleveland VA SCI/D unit or treated in the outpatient clinic

Exclusion criteria

  • No phone
  • Cognitive impairment
  • Hearing impairment

Treatment and study plan

Daily telephone calls

Behavioral

Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers.

Weekly telephone calls

Behavioral

Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.

Primary outcomes

  1. Days of Data

    Time frame: Enrollment to study end, 8 weeks

    Data includes the number of triggered items and types of triggers.

  2. Number of Days With Triggers at Certain Timeframe

    Time frame: Enrollment to study end, 8 weeks

    Measured the number of days with triggers that occurred on the Baseline day, during the 8-week intervention, and on the End of Study day.

  3. Percent of Participant Triggering DMP Items

    Time frame: Enrollment to study end, 8 weeks

    Percent of participants who triggered Disease-Management Protocol items by group.

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 27, 2008
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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