Study Stopped
Study was withdrawn because of a problem with the software used for generating the aftercare summary.
Does Use of a Wound After-care Summary Improve Patient Satisfaction and Time to Wound Healing?
1 other identifier
interventional
N/A
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2008
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 29, 2008
CompletedFirst Posted
Study publicly available on registry
September 30, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedMay 6, 2015
May 1, 2015
11 months
September 29, 2008
May 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
patient satisfaction, frequency of self-management activities, time to healing
Outcomes are measured at each participating patient's visit for one year or until the patient's wound is healed, whichever comes first.
Study Arms (2)
Arm 1
EXPERIMENTALThese patients receive the experimental intervention--the after-care summary.
Arm 2
ACTIVE COMPARATORThese patients are the control group and receive usual care.
Interventions
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.
Patients in the control group will receive usual counseling for self-management.
Eligibility Criteria
You may not qualify if:
- Cognitively impaired patients who cannot give informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105, United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julie C Lowery, PhD MHSA
VA Ann Arbor Healthcare System, Ann Arbor, MI
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2008
First Posted
September 30, 2008
Study Start
July 1, 2008
Primary Completion
June 1, 2009
Study Completion
December 1, 2009
Last Updated
May 6, 2015
Record last verified: 2015-05