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

Primary Purpose

Wounds

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
After-care summary
Control group
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wounds focused on measuring wound healing, self-management, patient education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA Ann Arbor Healthcare System, Ann Arbor, MI
  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm Description

These patients receive the experimental intervention--the after-care summary.

These patients are the control group and receive usual care.

Outcomes

Primary Outcome Measures

patient satisfaction, frequency of self-management activities, time to healing

Secondary Outcome Measures

Full Information

First Posted
September 29, 2008
Last Updated
May 5, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00761839
Brief Title
Does Use of a Wound After-care Summary Improve Patient Satisfaction and Time to Wound Healing?
Official Title
Does Use of a Wound After-care Summary Improve Patient Satisfaction and Time to Wound Healing?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Study was withdrawn because of a problem with the software used for generating the aftercare summary.
Study Start Date
July 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds
Keywords
wound healing, self-management, patient education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
These patients receive the experimental intervention--the after-care summary.
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
These patients are the control group and receive usual care.
Intervention Type
Behavioral
Intervention Name(s)
After-care summary
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control group
Intervention Description
Patients in the control group will receive usual counseling for self-management.
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie C Lowery, PhD MHSA
Organizational Affiliation
VA Ann Arbor Healthcare System, Ann Arbor, MI
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Ann Arbor Healthcare System, Ann Arbor, MI
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
VA Puget Sound Health Care System Seattle Division, Seattle, WA
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

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

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