Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study: rationale and design for a randomized controlled trial evaluating rheumatoid arthritis risk education to first-degree relatives
| Autor: | Maura D. Iversen, Nellie A. Triedman, Elizabeth W. Karlson, Jeffrey A. Sparks, Michael L. Atkinson, Bing Lu, Sarah S. Kalia, Robert C. Green, Karen H. Costenbader, Taysir G Mahmoud, Kevin D. Deane, Rachel Miller Kroouze |
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| Rok vydání: | 2014 |
| Předmět: |
Research design
Adult Male medicine.medical_specialty Adolescent Health Behavior Oral Health Article law.invention Arthritis Rheumatoid Young Adult Sex Factors Randomized controlled trial Patient Education as Topic law Risk Factors medicine Humans Pharmacology (medical) Family Genetic Predisposition to Disease Prospective Studies First-degree relatives Family history Life Style Aged business.industry Smoking Absolute risk reduction Age Factors General Medicine Middle Aged Overweight Diet Risk Estimate Socioeconomic Factors Research Design Physical therapy Biomarker (medicine) Female Personalized medicine business Biomarkers |
| Zdroj: | Contemporary clinical trials. 39(1) |
| ISSN: | 1559-2030 |
| Popis: | We present the rationale, design features, and protocol of the Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) Family Study (ClinicalTrials.gov NCT02046005). The PRE-RA Family Study is an NIH-funded prospective, randomized controlled trial designed to compare the willingness to change behaviors in first-degree relatives of rheumatoid arthritis (RA) patients without RA after exposure to RA risk educational programs. Consented subjects are randomized to receive education concerning their personalized RA risk based on demographics, RA-associated behaviors, genetics, and biomarkers or to receive standard RA information. Four behavioral factors associated with RA risk were identified from prior studies for inclusion in the risk estimate: cigarette smoking, excess body weight, poor oral health, and low fish intake. Personalized RA risk information is presented through an online tool that collects data on an individual's specific age, gender, family history, and risk-related behaviors; presents genetic and biomarker results; displays relative and absolute risk of RA; and provides personalized feedback and education. The trial outcomes will be changes in willingness to alter behaviors from baseline to 6 weeks, 6 months, and 12 months in the three intervention groups. The design and the execution of this trial that targets a special population at risk for RA, while incorporating varied risk factors into a single risk tool, offer distinct challenges. We provide the theoretical rationale for the PRE-RA Family Study and highlight particular design features of this trial that utilize personalized risk education as an intervention. |
| Databáze: | OpenAIRE |
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