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

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Daily telephone calls
Weekly telephone calls
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Cord Injury focused on measuring Pressure ulcer, Telemedicine

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • No phone
  • Cognitive impairment
  • Hearing impairment

Sites / Locations

  • Edward Hines Jr. VA Hospital, Hines, IL
  • Louis Stokes VA Medical Center, Cleveland, OH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Daily telephone calls

Weekly telephone calls

Arm Description

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

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

Outcomes

Primary Outcome Measures

Days of Data
Data includes the number of triggered items and types of triggers.
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.
Percent of Participant Triggering DMP Items
Percent of participants who triggered Disease-Management Protocol items by group.

Secondary Outcome Measures

Full Information

First Posted
February 14, 2008
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00624806
Brief Title
Developing a Home Telehealth Program to Manage Pressure Ulcers in SCI/D
Official Title
Developing a Home Telehealth Program to Manage Pressure Ulcers in SCI/D
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Pressure ulcer, Telemedicine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daily telephone calls
Arm Type
Experimental
Arm Description
Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers
Arm Title
Weekly telephone calls
Arm Type
Active Comparator
Arm Description
Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.
Intervention Type
Behavioral
Intervention Name(s)
Daily telephone calls
Intervention Description
Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers.
Intervention Type
Behavioral
Intervention Name(s)
Weekly telephone calls
Intervention Description
Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.
Primary Outcome Measure Information:
Title
Days of Data
Description
Data includes the number of triggered items and types of triggers.
Time Frame
Enrollment to study end, 8 weeks
Title
Number of Days With Triggers at Certain Timeframe
Description
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.
Time Frame
Enrollment to study end, 8 weeks
Title
Percent of Participant Triggering DMP Items
Description
Percent of participants who triggered Disease-Management Protocol items by group.
Time Frame
Enrollment to study end, 8 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Veterans admitted to Cleveland VA SCI/D unit or treated in the outpatient clinic Exclusion Criteria: No phone Cognitive impairment Hearing impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marylou Guihan, PhD MA BA
Organizational Affiliation
Edward Hines Jr. VA Hospital, Hines, IL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Edward Hines Jr. VA Hospital, Hines, IL
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141-5000
Country
United States
Facility Name
Louis Stokes VA Medical Center, Cleveland, OH
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21756573
Citation
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. Erratum In: J Spinal Cord Med. 2011 Jul;34(4):437.
Results Reference
result

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

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