CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 286 enrolled
Drug / intervention
Medication Guides +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/NCT02820038
NCT02820038N/ACompleted

Enhancing Patient Ability to Understand and Utilize Complex Information Concerning Medication Self-management

University of North Carolina, Chapel Hill·interventional·Posted Jun 30, 2016·Updated Jan 18, 2020

In Brief

A clinical study evaluating Medication Guides, SMART Program, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 286 participants across 1 site.

Detailed Summary

The aim of the proposed project is to compare the effectiveness of two strategies designed to enhance patient understanding of medication risks/benefits: (1) Medication Guides, mandated for many medications by the Food and Drug Administration and (2) Drug Facts Boxes, developed by Woloshin and Schwartz to enhance the usability of consumer medication information. The investigators will also assess whether the effectiveness of these communication strategies can be increased by Gist Reasoning Training, which is designed to enhance patients' ability to extract meaningful gist from complex information.The investigators anticipate enrolling 300 individuals with rheumatoid arthritis. The study will use a randomized controlled trial design with four study arms. Data will be collected primarily via self-administered, Internet-based surveys using REDCap. All participants will be followed for 6 months after the completion of baseline data collection.

Study Details

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 30, 2016
Enrollment StartSep 1, 2016
Primary CompletionDec 31, 2018
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 10.0 years ago

Interventions

Medication Guidesbehavioral

The investigators will compare the effectiveness of two types of written prescription drug information targeted for patients: (1) Medication Guides mandated by the Food and Drug Administration, and (2) Drug Facts Boxes, developed by Woloshin and Schwartz.

SMART Programbehavioral

The investigators will determine if the effectiveness of written medication information can be increased by Gist Reasoning Training, delivered via the SMART Program, which is designed to enhance patients' ability to extract meaningful gist from complex information.

Drug Facts Boxesbehavioral

The investigators will compare the effectiveness of two types of written prescription drug information targeted for patients: (1) Medication Guides mandated by the Food and Drug Administration, and (2) Drug Facts Boxes, developed by Woloshin and Schwartz.