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

This study has suspended participant recruitment.
(Recruitment has been suspended because of a problem with the software used for generating the aftercare summary.)
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00761839
First received: September 29, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Does Use of a Wound After-Care Summary Improve Patient Satisfaction and Time to Wound Healing?

Further study details as provided by Department of Veterans Affairs:

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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00761839

Locations
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48113
United States, Washington
VA Puget Sound Health Care System, Seattle
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Investigators
Principal Investigator: Julie C. Lowery, PhD MHSA VA Ann Arbor Healthcare System
  More Information

No publications provided

Responsible Party: Lowery, Julie - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00761839     History of Changes
Other Study ID Numbers: XVA 41-027
Study First Received: September 29, 2008
Last Updated: September 29, 2008
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
wound healing
self-management
patient education

ClinicalTrials.gov processed this record on August 01, 2014