NCT00761839

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

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

2 active sites

Status
withdrawn

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

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

May 6, 2015

Status Verified

May 1, 2015

Enrollment Period

11 months

First QC Date

September 29, 2008

Last Update Submit

May 5, 2015

Conditions

Keywords

wound healingself-managementpatient education

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

EXPERIMENTAL

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

Behavioral: After-care summary

Arm 2

ACTIVE COMPARATOR

These patients are the control group and receive usual care.

Behavioral: Control group

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.

Arm 1
Control groupBEHAVIORAL

Patients in the control group will receive usual counseling for self-management.

Arm 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Julie C Lowery, PhD MHSA

    VA Ann Arbor Healthcare System, Ann Arbor, MI

    PRINCIPAL INVESTIGATOR
0

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

Locations