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Personalized Risk Estimator for Rheumatoid Arthritis Family Study (PRE-RA)

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ClinicalTrials.gov Identifier: NCT02046005
Recruitment Status : Completed
First Posted : January 27, 2014
Results First Posted : June 7, 2018
Last Update Posted : August 8, 2018
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Elizabeth Karlson, M.D., Brigham and Women's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition First Degree Relatives of Rheumatoid Arthritis Patients
Interventions Behavioral: PRE-RA
Behavioral: PRE-RA Plus
Behavioral: General Rheumatoid Arthritis Education
Enrollment 238
Recruitment Details  
Pre-assignment Details  
Arm/Group Title General Rheumatoid Arthritis Education PRE-RA PRE-RA Plus
Hide Arm/Group Description

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.

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.

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.

Period Title: Overall Study
Started 80 78 80
Completed 72 71 70
Not Completed 8 7 10
Arm/Group Title General Rheumatoid Arthritis Education PRE-RA PRE-RA Plus Total
Hide Arm/Group Description

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 80 78 80 238
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 80 participants 78 participants 80 participants 238 participants
43.4  (14.7) 45.0  (14.9) 48.3  (13.7) 45.6  (14.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 78 participants 80 participants 238 participants
Female
63
  78.8%
62
  79.5%
57
  71.3%
182
  76.5%
Male
17
  21.3%
16
  20.5%
23
  28.7%
56
  23.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 80 participants 78 participants 80 participants 238 participants
White
69
  86.3%
65
  83.3%
73
  91.3%
207
  87.0%
Non-White
11
  13.8%
13
  16.7%
7
   8.8%
31
  13.0%
1.Primary Outcome
Title Contemplation Ladder
Hide Description 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.
Time Frame Immediately, 6 weeks, and 6 months after intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title General Rheumatoid Arthritis Education PRE-RA PRE-RA Plus
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 80 78 80
Measure Type: Count of Participants
Unit of Measure: Participants
Immediately post-intervention
40
  50.0%
46
  59.0%
43
  53.8%
6 weeks post-intervention
41
  51.2%
49
  62.8%
45
  56.3%
6 months post-intervention
40
  50.0%
53
  67.9%
48
  60.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection General Rheumatoid Arthritis Education, PRE-RA, PRE-RA Plus
Comments In the primary analysis, we combined the PRE-RA and PRE-RA Plus arms into a single "PRE-RA group" and compared it to the Comparison arm (aka "General Rheumatoid Arthritis Education")
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.043
Comments We compared the PRE-RA group (PRE-RA arm and PRE-RA Plus arm combined) to the Comparison arm for the primary composite outcome at the 3 primary post-intervention time points using generalized estimating equations (GEE).
Method generalized estimating equations
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.23
Confidence Interval (2-Sided) 95%
1.01 to 1.51
Estimation Comments PRE-RA group (combined PRE-RA arm and PRE-RA Plus arm) compared to Comparison arm (reference)
Time Frame 1 year
Adverse Event Reporting Description Behavioral intervention
 
Arm/Group Title General Rheumatoid Arthritis Education PRE-RA PRE-RA Plus
Hide Arm/Group Description

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.

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.

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.

All-Cause Mortality
General Rheumatoid Arthritis Education PRE-RA PRE-RA Plus
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/80 (0.00%)   0/78 (0.00%)   0/80 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
General Rheumatoid Arthritis Education PRE-RA PRE-RA Plus
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/80 (0.00%)   0/78 (0.00%)   0/80 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
General Rheumatoid Arthritis Education PRE-RA PRE-RA Plus
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/80 (0.00%)   0/78 (0.00%)   0/80 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Elizabeth Karlson
Organization: Brigham and Women's Hospital
Phone: 617-732-5078
Responsible Party: Elizabeth Karlson, M.D., Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02046005     History of Changes
Other Study ID Numbers: P60 AR047782-6121
P60AR047782 ( U.S. NIH Grant/Contract )
First Submitted: January 23, 2014
First Posted: January 27, 2014
Results First Submitted: January 16, 2018
Results First Posted: June 7, 2018
Last Update Posted: August 8, 2018