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NCT06864754

WashU DIEP Flap Video and Patient Understanding Improvement

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)

At risk: Primary completion moved 12 months later.

See at-risk trials from Washington University School of Medicine

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Record History

All 7 versions: 6 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Oct 31, 2026 to Oct 31, 2027
    • Eligibility criteria expanded, about 4 words
    • Secondary endpoints: details revised at 1 of 3 entries
  2. Primary and study completion dates: Sep 30, 2026 to Oct 31, 2026
    • Secondary endpoints: details revised at 3 of 3 entries
    v6
  3. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Aug 31, 2026 to Sep 30, 2026
    • Start date changed from estimate of Jun 30, 2025 to Jul 18, 2025
    • Site details revised
    v5
  4. Start date: Apr 30, 2025 to Jun 30, 2025
    • Primary and study completion dates: Jun 30, 2026 to Aug 31, 2026
    v4
  5. Primary endpoints revised (2)v2
  6. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Change in understanding as measured by the Comprehension Assessment
Timeframe: Before video at pre-operative visit, after video at pre-operative visit, and at post-operative visit (estimated to be 3 months)
Change in anxiety as measured by the Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Timeframe: Before video at pre-operative visit, after video at pre-operative visit, and at post-operative visit (estimated to be 3 months)

Secondary (3)

Appropriate expectation setting as measured by The Patient Education Materials Assessment Tool (PEMAT)
Appropriate expectation setting as measured by the Acceptability of Intervention Measure (AIM)
Appropriate expectation setting as measured by the Intervention Appropriateness Measure (IAM)

Arms and interventions

WashU DIEP Flap VideoExperimental

At the pre-operative appointment, patients will complete the pre-video survey (\~10min) via RedCap, watch the video (\~5min), and complete the post-video survey (\~10min) via RedCap. During the standard of care follow-up appointment ≤ 30 days after surgery, consented patients will fill out a third survey via RedCap (\~5min).

Other: WashU DIEP Flap Video

Sites

1 site in 1 country

  • Washington University School of MedicineSt Louis, Missouri, United States