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Does Use of a Wound After-care Summary Improve Patient Satisfaction and Time to Wound Healing?

This study has been withdrawn prior to enrollment.
(Study was withdrawn because of a problem with the software used for generating the aftercare summary.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00761839
First Posted: September 30, 2008
Last Update Posted: May 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
The purpose of this research study is to evaluate a patient education program for chronic wound care. The wound care nurse practitioner (NP) at the Ann Arbor VAMC will use a wound self-management "after-care summary" with approximately half of her patients. This study will examine whether using this patient education tool for self-management of wound care results in improved patient outcomes.

Condition Intervention
Wounds Behavioral: After-care summary Behavioral: Control group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Use of a Wound After-care Summary Improve Patient Satisfaction and Time to Wound Healing?

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • patient satisfaction, frequency of self-management activities, time to healing [ Time Frame: Outcomes are measured at each participating patient's visit for one year or until the patient's wound is healed, whichever comes first. ]

Enrollment: 0
Study Start Date: July 2008
Study Completion Date: December 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
These patients receive the experimental intervention--the after-care summary.
Behavioral: After-care summary
The wound care NP will measure the wound and assess adherence to the following self-management activities: visiting the wound care clinic as scheduled; offloading; applying dressings; obtaining assistance at home; and participating in social activities. This information will be entered into a computer database on a VA computer that will generate a summary chart showing the relationship between adherence and wound healing. The generated "after-care summary" will be discussed with the patient and used to set self-management goals.
Active Comparator: Arm 2
These patients are the control group and receive usual care.
Behavioral: Control group
Patients in the control group will receive usual counseling for self-management.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All patients presenting for outpatient wound care at the Ann Arbor VA Medical Center NP wound care clinic, who meet the following inclusion criteria for chronic wounds: stage II, III, IV pressure ulcers; venous stasis ulcers, and diabetic ulcers.

Exclusion Criteria:

Cognitively impaired patients who cannot give informed consent.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00761839


Locations
United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States, 48105
United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Julie C Lowery, PhD MHSA VA Ann Arbor Healthcare System, Ann Arbor, MI
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00761839     History of Changes
Other Study ID Numbers: XVA 41-027
First Submitted: September 29, 2008
First Posted: September 30, 2008
Last Update Posted: May 6, 2015
Last Verified: May 2015

Keywords provided by VA Office of Research and Development:
wound healing
self-management
patient education

Additional relevant MeSH terms:
Wounds and Injuries