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

This study is currently recruiting participants.

Verified by Department of Veterans Affairs, August 2008

Sponsored by:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00624806

Purpose

The practical impact of this research will be to develop, evaluate and validate the home telehealth disease management protocol items to help patients with spinal cord injury manage/prevent skin breakdown.

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

MedlinePlus related topics: Pressure Sores Spinal Cord Injuries

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Developing a Home Telehealth Program to Manage Pressure Ulcers in SCI/D

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 ]

Estimated Enrollment:	50
Study Start Date:	February 2008
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Experimental 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.

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Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

- Veterans admitted to Cleveland VA SCI unit

Exclusion Criteria:

No phone
Cognitive impairment

Contacts and Locations

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

Contacts

Contact: Marylou Guihan, PhD MA BA	(708) 202-5870	marylou.guihan@va.gov
Contact: Chester H Ho, MD	(216) 791-3800 ext 5520	chester.ho@va.gov

Locations

United States, Illinois
Edward Hines, Jr. VA Hospital	Active, not recruiting
Hines, Illinois, United States, 60141-5000
United States, Ohio
VA Medical Center, Cleveland	Recruiting
Cleveland, Ohio, United States, 44106-3800
Contact: Chester H Ho, MD 216-791-3800 ext 5520 chester.ho@va.gov
Sub-Investigator: Chester H. Ho, MD

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Marylou Guihan, PhD MA BA

Edward Hines Jr. VA Hospital

More Information

Responsible Party:	Department of Veterans Affairs ( Guihan, Marylou - Principal Investigator )
Study ID Numbers:	RRP 07-292
Study First Received:	February 14, 2008
Last Updated:	August 8, 2008
ClinicalTrials.gov Identifier:	NCT00624806
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

Pressure ulcer
Telemedicine

Study placed in the following topic categories:

Spinal Cord Injuries
Spinal Cord Diseases
Skin Diseases
Ulcer
Wounds and Injuries

Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System
Skin Ulcer
Pressure Ulcer

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009