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Study delayed for over a year by research shutdown at Seattle VA and other issues. Study designer moved to Ann Arbor in the interim, so the study was closed.
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The purpose of this study is to determine whether individualized wound prevention instructions will lengthen the ulcer-free period in veterans with recently healed venous ulcers.
Venous ulcer disease is the most common form of lower extremity ulcer, and treatment requires months to years of costly intervention. Preventing venous ulcers from recurring is ideal, however, healing time is variable, possibly due to inadequate patient/clinician communication and surveillance. An aftercare summary is a detailed set of self-care instructions designed to help patients understand and influence preventative factors under their control. They have successfully been used in patients with cardiac disease and are currently being tested to help prevent diabetic foot ulcers. We propose the use of an aftercare summary to help prevent ulcer recurrence in veterans with recently healed venous ulcers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Will receive usual wound prevention care, aftercare summaries, and regular surveillance. |
|
| 2 | No Intervention | Will receive usual wound prevention and surveillance only. | |
| 3 | No Intervention | Will receive usual wound prevention only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aftercare summary | Behavioral | A personalized, targeted set of self-care instructions for venous ulcer prevention, including a graphical depiction of patient adherence to self-care goals. |
| Measure | Description | Time Frame |
|---|---|---|
| Ulcer-free survival period | Telephone call every 2 weeks, on-site visit quarterly (depends on study arm) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life | Telephone call every 2 weeks, on-site visit at 2.5 and 5 months. | |
| Change in satisfaction with care | Telephone call every 2 weeks, on-site visit at 2.5 and 5 months. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gayle E. Reiber, MPH PhD | VA Puget Sound Health Care System, Seattle | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Puget Sound Health Care System, Seattle | Seattle | Washington | 98101 | United States |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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| Adherence with self-management goals |
| Telephone call every 2 weeks, on-site visit at 2.5 and 5 months. |
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |