CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,273 enrolled
Drug / intervention
In-person +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03006913
NCT03006913N/ACompleted

Comparison of 3 Modes of Genetic Counseling in High-Risk Public Hospital

University of California, San Francisco·interventional·Posted Dec 30, 2016·Updated Mar 21, 2025

In Brief

A clinical study evaluating In-person, By phone, and 1 other intervention for Genetic Counseling. Completed, enrolled 1,273 participants across 3 sites.

Detailed Summary

Using mixed methods, investigators will conduct a multicenter partially randomized preference noninferiority trial with high-risk English-, Spanish-, and Cantonese-speaking patients assigned by (1) patients´ preference or (2) randomization to three counseling modes: (a) in-person; (b) phone; or (c) video conference. A total of 600 patients will complete counseling and 540 will complete the final survey. Baseline and post-counseling surveys will use validated measures (adapted for literacy and language) of study outcomes. All counseling sessions will be audio-taped. A sample of 90 tapes will be analyzed for counseling content and to identify 30 participants for in-depth interviews and analysis triangulating all forms of data. Genetic counselors will be interviewed in depth to elicit their perceptions of the strengths and limitations of each counseling mode.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedDec 30, 2016
Enrollment StartApr 18, 2017
Primary CompletionDec 16, 2019
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.5 years ago

Interventions

In-personbehavioral

At all sites, patients randomized to/preferring in-person counseling will meet with a counselor.

By phonebehavioral

Patients in the phone arm will receive a scheduled call at their home.

By videobehavioral

Because low income patients are not likely to have video conference capability at home, this service will be offered at all three hospitals, and patients will have scheduled appointments to come to the hospital to receive counseling delivered through a computer.