Study of Individualized Wound Prevention Instruction to Prevent Venous Ulcer Development
|ClinicalTrials.gov Identifier: NCT00727701|
Recruitment Status : Terminated (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.)
First Posted : August 4, 2008
Last Update Posted : June 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Varicose Ulcer||Behavioral: Aftercare summary||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Does Use of a Wound After-care Summary for Patients With a History of Venous Ulcers Lower Recurrence Rate?|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
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.
- Ulcer-free survival period [ Time Frame: Telephone call every 2 weeks, on-site visit quarterly (depends on study arm) ]
- Change in quality of life [ Time Frame: Telephone call every 2 weeks, on-site visit at 2.5 and 5 months. ]
- Change in satisfaction with care [ Time Frame: Telephone call every 2 weeks, on-site visit at 2.5 and 5 months. ]
- Adherence with self-management goals [ Time Frame: Telephone call every 2 weeks, on-site visit at 2.5 and 5 months. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|