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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04372888
Other study ID # 20.205.01e
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 11, 2020
Est. completion date March 30, 2020

Study information

Verified date July 2021
Source Boston College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this application is to gain a deeper understanding of decision-making for genetic testing and identify effective choice-architecture-based strategies to improve decisions in genetic testing. The investigators hypothesize that choice architecture (i.e. framing) affects decision-making for hypothetical genetic testing scenarios.


Description:

After providing opt-in electronic consent, eligible consented participants will be randomized to one of two hypothetical genetic testing scenarios (rare, life-altering genetic condition or common, life-threatening genetic condition). The genetic testing scenarios include brief detailed information about genetic testing (i.e. how results may influence treatment decisions) as well as information about standard approaches to treatment. Subjects will be randomized to receive a framing conditions (e.g. choice, opt-in, opt-out, enhanced choice). Participants will select a preferred testing option to the hypothetical scenario and will complete several validated instruments.


Recruitment information / eligibility

Status Completed
Enrollment 1012
Est. completion date March 30, 2020
Est. primary completion date March 26, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria: - Adult participants (18-64 yrs) residing in North America (who are members of the Amazon Mechanical Turk platform) Exclusion Criteria: - age <18yrs or >65yrs or residing outside of North America

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
choice decision frame
active choice for genetic testing
opt-in decision frame
"gain" frame for genetic testing
opt-out decision frame
"loss" frame for genetic testing
enhanced choice (context) decision frame
consequences of genetic testing
enhanced choice (norms) decision frame
social norms for genetic testing
enhanced choice (affect) decision frame
commitments for genetic testing

Locations

Country Name City State
United States Boston College Chestnut Hill Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Boston College

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dwyer AA, Shen H, Zeng Z, Gregas M, Zhao M. Framing Effects on Decision-Making for Diagnostic Genetic Testing: Results from a Randomized Trial. Genes (Basel). 2021 Jun 20;12(6). pii: 941. doi: 10.3390/genes12060941. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Genetic testing decision Opting "yes" for genetic testing or "no" refusing genetic testing after reading the scenario and viewing frame (approximately 10 minutes)
Primary Satisfaction with Decision Scale (SWD) SWD is a validated 6-item instrument, items are scored on a 1-5 scale with higher scores indicating greater satisfaction with the decision taken study completion (approximately 30 minutes)
Primary Decisional Regret Scale (DRS) DRS is a validated 5-item instrument, items are scored on a 1-5 scale with higher scores indicating more regret with the decision taken study completion (approximately 30 minutes)
Secondary Newest Vital Sign (NVS) NVS is a validated 6-item instrument, questions are based on reading and interpreting a food label, higher scores (more correct answers) indicate greater levels of literacy and numeracy abilities study completion (approximately 30 minutes)
Secondary Experience with genetic disease Single "yes"/"no" question to determine a personal or family experience the genetic condition being presented in the scenario (arm) Baseline (study onset)
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