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Clinical Trials/NCT00624806
NCT00624806CompletedNot Applicable

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

US Department of Veterans Affairs2 sites in 1 country18 target enrollmentStarted: February 1, 2008Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
18
Locations
2
Primary Endpoint
Days of Data

Study Overview

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:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Investigator)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • •Cognitive impairment
  • •Hearing impairment

Arms & Interventions

Daily telephone calls

Experimental

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

Intervention: Daily telephone calls (Behavioral)

Weekly telephone calls

Active Comparator

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

Intervention: Weekly telephone calls (Behavioral)

Outcomes

Primary Outcomes

Days of Data

Time Frame: 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

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

Study Sites (2)

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