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

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00624806
• Other study ID #: RRP 07-292
• Status: Completed
• Phase: N/A
• First received: February 14, 2008
• Last updated: April 6, 2015
• Start date: February 2008
• Est. completion date: November 2009

Study information

• Verified date: July 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pressure Ulcer
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

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

Locations

Country	Name	City	State
United States	Louis Stokes VA Medical Center, Cleveland, OH	Cleveland	Ohio
United States	Edward Hines Jr. VA Hospital, Hines, IL	Hines	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Woo C, Guihan M, Frick C, Gill CM, Ho CH. What's happening now! Telehealth management of spinal cord injury/disorders. J Spinal Cord Med. 2011;34(3):322-31. doi: 10.1179/2045772311Y.0000000003. Review. Erratum in: J Spinal Cord Med. 2011 Jul;34(4):437. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days of Data	Data includes the number of triggered items and types of triggers.	Enrollment to study end, 8 weeks	No
Primary	Number of Days With Triggers at Certain Timeframe	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.	Enrollment to study end, 8 weeks	No
Primary	Percent of Participant Triggering DMP Items	Percent of participants who triggered Disease-Management Protocol items by group.	Enrollment to study end, 8 weeks	No