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

Group	Intervention	Description
Daily telephone calls	Daily telephone calls	Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers
Weekly telephone calls	Weekly telephone calls	Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.

Primary Outcome Measures

Name	Time	Method
Days of Data	Enrollment to study end, 8 weeks	Data includes the number of triggered items and types of triggers.
Number of Days With Triggers at Certain Timeframe	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.
Percent of Participant Triggering DMP Items	Enrollment to study end, 8 weeks	Percent of participants who triggered Disease-Management Protocol items by group.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (2): Edward Hines Jr. VA Hospital, Hines, IL
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Hines, Illinois, United States
Louis Stokes VA Medical Center, Cleveland, OH
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Cleveland, Ohio, United States