Trial Outcomes & Findings for Personalized Risk Estimator for Rheumatoid Arthritis Family Study (NCT NCT02046005)

Results Overview

Measures willingness to change any of 4 RA-related behaviors compared to baseline using generalized estimating equations to compare the PRE-RA groups to the comparison arm.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

238 participants

Primary outcome timeframe

Immediately, 6 weeks, and 6 months after intervention

Results posted on

2018-08-08

Participant Flow

Participant milestones

Participant milestones
Measure	General Rheumatoid Arthritis Education Arm 1 participants will receive general information about RA. General Rheumatoid Arthritis Education: Participants will receive general information about signs and symptoms of rheumatoid arthritis.	PRE-RA Arm 2 participants will receive personalized RA risk education by the PRE-RA risk tool. PRE-RA: Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) is an online tool that provides education about RA, collects data about demographics and behaviors, and presents personalized RA risk information.	PRE-RA Plus Arm 3 participants will receive personalized RA risk education by the PRE-RA risk tool and health educator. PRE-RA Plus: Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) is an online tool that provides education about RA, collects data about demographics and behaviors, and presents personalized RA risk information. In addition, participants in this arm receive education from a health educator.
Overall Study STARTED	80	78	80
Overall Study COMPLETED	72	71	70
Overall Study NOT COMPLETED	8	7	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Personalized Risk Estimator for Rheumatoid Arthritis Family Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	General Rheumatoid Arthritis Education n=80 Participants Arm 1 participants will receive general information about RA. General Rheumatoid Arthritis Education: Participants will receive general information about signs and symptoms of rheumatoid arthritis.	PRE-RA n=78 Participants Arm 2 participants will receive personalized RA risk education by the PRE-RA risk tool. PRE-RA: Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) is an online tool that provides education about RA, collects data about demographics and behaviors, and presents personalized RA risk information.	PRE-RA Plus n=80 Participants Arm 3 participants will receive personalized RA risk education by the PRE-RA risk tool and health educator. PRE-RA Plus: Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) is an online tool that provides education about RA, collects data about demographics and behaviors, and presents personalized RA risk information. In addition, participants in this arm receive education from a health educator.	Total n=238 Participants Total of all reporting groups
Age, Continuous	43.4 years STANDARD_DEVIATION 14.7 • n=5 Participants	45.0 years STANDARD_DEVIATION 14.9 • n=7 Participants	48.3 years STANDARD_DEVIATION 13.7 • n=5 Participants	45.6 years STANDARD_DEVIATION 14.5 • n=4 Participants
Sex: Female, Male Female	63 Participants n=5 Participants	62 Participants n=7 Participants	57 Participants n=5 Participants	182 Participants n=4 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	16 Participants n=7 Participants	23 Participants n=5 Participants	56 Participants n=4 Participants
Race/Ethnicity, Customized White	69 Participants n=5 Participants	65 Participants n=7 Participants	73 Participants n=5 Participants	207 Participants n=4 Participants
Race/Ethnicity, Customized Non-White	11 Participants n=5 Participants	13 Participants n=7 Participants	7 Participants n=5 Participants	31 Participants n=4 Participants

PRIMARY outcome

Timeframe: Immediately, 6 weeks, and 6 months after intervention

Measures willingness to change any of 4 RA-related behaviors compared to baseline using generalized estimating equations to compare the PRE-RA groups to the comparison arm.

Outcome measures

Outcome measures
Measure	General Rheumatoid Arthritis Education n=80 Participants Arm 1 participants will receive general information about RA. General Rheumatoid Arthritis Education: Participants will receive general information about signs and symptoms of rheumatoid arthritis.	PRE-RA n=78 Participants Arm 2 participants will receive personalized RA risk education by the PRE-RA risk tool. PRE-RA: Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) is an online tool that provides education about RA, collects data about demographics and behaviors, and presents personalized RA risk information.	PRE-RA Plus n=80 Participants Arm 3 participants will receive personalized RA risk education by the PRE-RA risk tool and health educator. PRE-RA Plus: Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) is an online tool that provides education about RA, collects data about demographics and behaviors, and presents personalized RA risk information. In addition, participants in this arm receive education from a health educator.
Contemplation Ladder Immediately post-intervention	40 Participants	46 Participants	43 Participants
Contemplation Ladder 6 weeks post-intervention	41 Participants	49 Participants	45 Participants
Contemplation Ladder 6 months post-intervention	40 Participants	53 Participants	48 Participants

Adverse Events

General Rheumatoid Arthritis Education

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PRE-RA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PRE-RA Plus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Elizabeth Karlson

Brigham and Women's Hospital

Phone: 617-732-5078

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place