Patient Reported Outcomes for Vascular Malformations EmbolizatioN (PROVEN)

Recruiting

• Conditions: VM - Vascular Malformation; Vascular Malformations

• Registration Number: NCT04104464
• Lead Sponsor: Johns Hopkins University

Brief Summary

The purpose of this study is to develop a standardized assessment for patients treated for venous malformations (VM).

Venous malformations result from the abnormal development of veins which may result in pain, swelling, bleeding, functional impairment, disfigurement, and psychological distress. The impact of VM on patient quality of life varies based on the location and size of the malformation.

A patient reported outcome (PRO) is a patient's own account of patient's health condition. PRO measures are valued to clinicians, as many treatment effects are known only to the patient. No studies to date have analyzed the validity of existing PRO measures for VM patients.

Current assessment does not include all symptoms or take in to account the relevance of VM location. Past studies show a discrepancy between treatment outcomes reported by patients and physicians. Therefore, there is a need to develop VM-specific PROs to better understand the effectiveness and benefits of treatment for VM.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-22
• Study First Submitted: 2019-09-24
• Study First Submitted QC: 2019-09-24
• Study First Posted: 2019-09-26
• Primary Completion: 2024-07-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-05
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Male and Female pediatric patients, aged between 0-17 with diagnosis of vascular malformations.
• Male and Female adult patients aged 18-100 with diagnosis of vascular malformations.
• Vascular malformation symptoms significant enough to seek treatment.

Exclusion Criteria

• Patients with extensive VM not suitable for sclerotherapy.
• Prior therapy for treatment of a VM within 3 months.
• Condition or impairment that may render the patient unable to take part in the study (e.g. cognitive, sight, hearing, etc.).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in patient reported relevancy of the PROVEN Questionnaire	1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year	Patients are asked to rate the personal relevancy and clarity of the survey questions with the options "Not at all", "A little bit", "Somewhat", "Quite a bit" or "Very Much".
Change in patient reported VM pain	1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year	Patients are asked to rate pain associated with VM during the past seven days on a 0-10 scale.
Change in patient reported efficacy of treatment	1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year	Patients are asked to rate the efficacy of their treatment with the options "Not at all", "A little bit", "Somewhat", "Quite a bit" or "Very Much".
Change in patient reported VM impact on daily life	1 month, 3 months and 6 months post-procedure; and all subsequent visits up to 1 year	Patients are asked to rate the impact that their VM has on daily life with the options "Not at all", "A little bit", "Somewhat", "Quite a bit" or "Very Much".

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States