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NCT03988569: ECAPS
Enhanced Consent and Preparedness for Surgery Trial
NA trial testing audiovisual decision aid in Stress Urinary Incontinence in 158 participants. Completed in 22 February 2024.
20 December 2023
Quick facts
| Lead sponsor | Loyola University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 158 |
| Start date | 1 July 2019 |
| Primary completion | 20 December 2023 |
| Estimated completion | 22 February 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- audiovisual decision aid
Conditions studied
- Stress Urinary Incontinence — all drugs for Stress Urinary Incontinence →
- Urge Incontinence — all drugs for Urge Incontinence →
- Pelvic Organ Prolapse — all drugs for Pelvic Organ Prolapse →
Sponsor
Loyola University
Who can join
18 and older, female only, with Stress Urinary Incontinence or Urge Incontinence. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To develop an audiovisual decision aid (AVDA) to improve the informed consent process. The investigators aim to examine the impact of a comprehensible AVDA that is written below the 8th grade reading level. The AVDA would be used for surgical consent compared to traditional verbal consent. Additionally, the investigators plan to determine whether this effect varies across the measured levels of health literacy of our patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03988569
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Loyola University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03988569 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Loyola University
- Last refreshed: 12 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03988569.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing