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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00624806
First received: February 14, 2008
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

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).


Condition Intervention
Spinal Cord Injury
Behavioral: Daily phone group
Behavioral: Weekly phone group

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Developing a Home Telehealth Program to Manage Pressure Ulcers in SCI/D

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Development of a pressure ulcer [ Time Frame: At enrollment ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: February 2008
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Arm 1
Daily telephone calls to remind patients of recommended behaviors
Behavioral: Daily phone group
Patients randomized to this group receive daily phone calls to remind them what they should do to prevent ulcers.
Arm 2
Weekly telephone calls to remind patients of recommended behaviors
Behavioral: Weekly phone group
Patients randomized to this group receive weekly phone calls to remind them what they should do to prevent ulcers.

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 RRP included: 1) Convening an expert panel to validate 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Veterans with SCI

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No phone
  • Cognitive impairment
  • Hearing impairment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624806

Locations
United States, Illinois
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141-5000
United States, Ohio
VA Medical Center, Cleveland
Cleveland, Ohio, United States, 44106-3800
Sponsors and Collaborators
Investigators
Principal Investigator: Marylou Guihan, PhD MA BA Edward Hines Jr. VA Hospital
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00624806     History of Changes
Other Study ID Numbers: RRP 07-292
Study First Received: February 14, 2008
Last Updated: July 18, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Pressure ulcer
Telemedicine

Additional relevant MeSH terms:
Pressure Ulcer
Spinal Cord Injuries
Ulcer
Wounds and Injuries
Skin Ulcer
Skin Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Pathologic Processes

ClinicalTrials.gov processed this record on August 19, 2014