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

Not Applicable
Completed
Conditions
Spinal Cord Injury
Interventions
Behavioral: Daily telephone calls
Behavioral: Weekly telephone calls
Registration Number
NCT00624806
Lead Sponsor
US Department of Veterans Affairs
Brief Summary

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).

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
18
Inclusion Criteria
  • Veterans admitted to Cleveland VA SCI/D unit or treated in the outpatient clinic
Exclusion Criteria
  • No phone
  • Cognitive impairment
  • Hearing impairment

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Daily telephone callsDaily telephone callsPatients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers
Weekly telephone callsWeekly telephone callsPatients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.
Primary Outcome Measures
NameTimeMethod
Days of DataEnrollment to study end, 8 weeks

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

Number of Days With Triggers at Certain TimeframeEnrollment 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.

Percent of Participant Triggering DMP ItemsEnrollment to study end, 8 weeks

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Edward Hines Jr. VA Hospital, Hines, IL

🇺🇸

Hines, Illinois, United States

Louis Stokes VA Medical Center, Cleveland, OH

🇺🇸

Cleveland, Ohio, United States

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