Study of Individualized Wound Prevention Instruction to Prevent Venous Ulcer Development
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Does Use of a Wound After-care Summary for Patients With a History of Venous Ulcers Lower Recurrence Rate?|
- Ulcer-free survival period [ Time Frame: Telephone call every 2 weeks, on-site visit quarterly (depends on study arm) ] [ Designated as safety issue: No ]
- Change in quality of life [ Time Frame: Telephone call every 2 weeks, on-site visit at 2.5 and 5 months. ] [ Designated as safety issue: No ]
- Change in satisfaction with care [ Time Frame: Telephone call every 2 weeks, on-site visit at 2.5 and 5 months. ] [ Designated as safety issue: No ]
- Adherence with self-management goals [ Time Frame: Telephone call every 2 weeks, on-site visit at 2.5 and 5 months. ] [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Will receive usual wound prevention care, aftercare summaries, and regular surveillance.
Behavioral: Aftercare summary
A personalized, targeted set of self-care instructions for venous ulcer prevention, including a graphical depiction of patient adherence to self-care goals.
No Intervention: 2
Will receive usual wound prevention and surveillance only.
No Intervention: 3
Will receive usual wound prevention only.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00727701
|United States, Washington|
|VA Puget Sound Health Care System, Seattle|
|Seattle, Washington, United States, 98101|
|Principal Investigator:||Gayle E. Reiber, MPH PhD||VA Puget Sound Health Care System, Seattle|