N/A
N=286
Enhancing Patient Ability to Understand and Utilize Complex Information Concerning Medication Self-management
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT02820038 ↗Enrolled (actual)
286
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Percentage of Participants Classified as Having Made an Informed Decision at 6 Months — 59.7; 44.2; 49.2; 55.8 percentage of participants — p=0.8408
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Medication Guides (Behavioral); SMART Program (Behavioral); Drug Facts Boxes (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Classified as Having Made an Informed Decision at 6 Months |
59.7; 44.2; 49.2; 55.8; 40.3; 55.8 | 0.8408 |
| SECONDARY Mean Knowledge of the Risks and Benefits Associated With DMARD Therapy at 6 Months Adjusted for Baseline |
81.9; 84.0; 82.1; 84.4 | 0.1630 |
| SECONDARY Mean Values at 6-Months Adjusted for Baseline |
6.3; 5.6; 5.5; 5.8 | 0.9216 |
| SECONDARY Mean Gist Reasoning Ability, Lesson Quality at 6 Month Follow-up Adjusted for Baseline |
1.1; 0.8; 1.0; 1.3 | 0.1486 |
| SECONDARY Mean Gist Reasoning Ability, Complex Abstraction at 6-Month Follow-up Adjusted for Baseline |
2.0; 2.0; 1.9; 1.8 | 0.5070 |
| SECONDARY Mean Satisfaction With Medication Information at 6-Month Follow-up Adjusted for Baseline |
13.0; 12.6; 12.6; 12.4 | 0.6084 |
| SECONDARY Mean Overall Treatment Satisfaction at 6-Month Follow-up Adjusted for Baseline |
69.4; 64.6; 66.0; 68.4 | 0.5866 |
| SECONDARY Mean Arthritis Self-Efficacy at 6-Month Follow-up Adjusted for Baseline |
47.4; 48.4; 49.4; 44.9 | 0.2366 |
| SECONDARY Mean Medication Adherence at 6-Month Follow-up Adjusted for Baseline |
92.3; 87.9; 95.5; 92.2 | 0.9604 |
| SECONDARY Mean Illness Intrusiveness at 6-Month Follow-up Adjusted for Baseline |
49.7; 50.0; 45.5; 45.7 | 0.3056 |
| SECONDARY Mean Health Distress at 6-Month Follow-up Adjusted for Baseline |
2.2; 2.1; 2.1; 2.4 | 0.1762 |
| SECONDARY Mean Global Health Status at 6-Month Follow-up Adjusted for Baseline |
2.5; 2.5; 2.5; 2.5 | 0.6403 |
| SECONDARY Mean Disease Activity at 6-Month Follow-up Adjusted for Baseline |
4.3; 4.4; 4.2; 4.2 | 0.7093 |
| SECONDARY Mean Depression at 6-Month Follow-up Adjusted for Baseline |
49.7; 50.4; 50.4; 50.2 | 0.9128 |
| SECONDARY Mean Fatigue at 6-Month Follow-up Adjusted for Baseline |
53.8; 53.9; 54.3; 55.3 | 0.2123 |
| SECONDARY Mean Health Literacy at 6-Month Follow-up Adjusted for Baseline |
73.9; 75.9; 73.9; 72.0 | 0.5364 |
| SECONDARY Information Seeking: Participating in BetterChoices, BetterHealth |
15; 10; 14; 11; 60; 63 | 0.7871 |
| SECONDARY Information Seeking: Use of RA Self-Management Website |
13; 10; 17; 10; 57; 61 | 0.5740 |
| SECONDARY Mean Visual Selective Learning at 6-Month Follow-up Adjusted for Baseline |
120.1; 109.3; 104.2; 99.2 | 0.17 |
| SECONDARY Mean Medication Self-Management Knowledge |
62.4; 64.9; 65.1; 66.1 | 0.15 |
| SECONDARY Mean Verbatim Recall of Information Concerning Medication Benefits and Risks |
0.60; 0.56; 0.44; 0.49 | 0.68 |
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.
Eligibility Criteria
Inclusion Criteria
- Age 18 years or older
- Able to speak and read in English
- Physician confirmed RA define by 1987 American College of Rheumatology criteria
- Moderate or highly active rheumatoid arthritis (assess by Routine Assessment of Patient Index Data 3 (RAPID3) score > 2.0) and
- Physician indicates patient is a candidate for initiation or escalation of Disease-modifying antirheumatic drug (DMARD) therapy
Exclusion Criteria
- Hearing or visually impaired
Data sourced from ClinicalTrials.gov (NCT02820038). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.