Lifestyle Intervention for Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to assess whether adding a multifaceted lifestyle intervention to the standard best practice of care can be more effective than standard best practices alone for treating Rheumatoid Arthritis.

Detailed Description
-----------------
The main purpose of this study is to assess whether adding a multifaceted lifestyle intervention to the standard best practice of care can be more effective than standard best practices alone for treating Rheumatoid Arthritis. If a lifestyle intervention is effective, we expect to see improvement in functional status and decreased health care costs to the study participant and the insurer.

Official Title
-----------------
A Lifestyle Intervention for Rheumatoid Arthritis: Effect of an Intensive Therapeutic Lifestyle Change Program on Inflammatory Markers and Clinical Outcomes

Conditions
-----------------
Lifestyle Risk Reduction, Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Behavioral: Intensive Lifestyle intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BCBSVT members who also carry the prescription benefit with BCBSVT (due to the need for tracking prescription costs). BCBSVT membership for minimum of 12 months prior to start of study (due to the need for tracking prescription costs before and after intervention). Age 18 or older Medical diagnosis of RA Exclusion Criteria: Pregnancy Currently taking warfarin (since fluctuating amounts of green leafy vegetable intake can adversely affect INR levels and because we will be asking participants to increase the amount of green leafy vegetables they consume) Malignancy currently undergoing treatment (with further planned treatment at the time of enrollment) since patients undergoing cancer treatment often need to stop RA medications in order to improve immune function, and thus could be a confounder. Food allergy (including reactions such as hives, wheezing, difficulty breathing, fainting, or anaphylaxis)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental<br>standard of care + lifestyle intervention | Behavioral: Intensive Lifestyle intervention<br>* 12 week therapeutic lifestyle change program<br>|
| No Intervention: control<br>no intervention (control group) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HAQ-2 score | The HAQ-II is a validated and reliable tool used frequently by rheumatologists evaluating patients with RA (Wolfe et al, 2004). It is an indicator of quality of life as well as functional status. It is also a predictor of premature mortality. | Up to 24 months | 
| Change in serum C-Reactive Protein | CRP is a reliable marker of acute and chronic inflammation (Sproston and Ashworth, 2018). | Up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in dosage of RA-related medications | Dosage of Medications Taken Specifically for Rheumatoid Arthritis | Up to 24 months | 
| Change in the number of medications required to treat RA | Number of Medications Taken Specifically for Rheumatoid Arthritis | Up to 24 months | 
| Change in RA-related costs for the study participant | Out of Pocket costs related to Rheumatoid Arthritis Care | Up to 24 months | 
| Change in RA-related costs to the insurer | Costs for care of Rheumatoid Arthritis paid by insurer | Up to 24 months | 
| Change in serum LDL cholesterol | Elevated Low Density Lipoprotein is strongly associated with heart disease | Up to 24 months | 
| Change in serum total cholesterol | Elevated total cholesterol is associated with heart disease | Up to 24 months | 
| Change in serum HbA1c | Hemoglobin HbA1c is used to assess glucose control in diabetics | Up to 24 months | 
| Change in blood pressure | Blood pressure change | Up to 24 months | 
| Change in BMI | Body Mass Index change | Up to 24 months | 
| Change in weight | Weight change | Up to 24 months |