Lifestyle Intervention for Rheumatoid Arthritis

Blue Cross Blue Shield of Vermont114 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

114

Conditions

Lifestyle Risk Reduction Rheumatoid Arthritis

Interventions

Intensive Lifestyle interventionBEHAVIORAL

12 week therapeutic lifestyle change program

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. BCBSVT members who also carry the prescription benefit with BCBSVT (due to the need for tracking prescription costs). 2. BCBSVT membership for minimum of 12 months prior to start of study (due to the need for tracking prescription costs before and after intervention). 3. Age 18 or older 4. Medical diagnosis of RA Exclusion Criteria: 1. Pregnancy 2. 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) 3. 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. 4. Food allergy (including reactions such as hives, wheezing, difficulty breathing, fainting, or anaphylaxis)

Locations (1)

Blue Cross Blue Shield of Vermont

Berlin Corners, Vermont, United States

Outcomes

Primary Outcomes

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.

Time frame: Up to 24 months

Change in serum C-Reactive Protein

CRP is a reliable marker of acute and chronic inflammation (Sproston and Ashworth, 2018).

Time frame: Up to 24 months

Secondary Outcomes

Change in dosage of RA-related medications

Dosage of Medications Taken Specifically for Rheumatoid Arthritis

Time frame: Up to 24 months

Change in the number of medications required to treat RA

Number of Medications Taken Specifically for Rheumatoid Arthritis

Time frame: Up to 24 months

Change in RA-related costs for the study participant

Out of Pocket costs related to Rheumatoid Arthritis Care

Time frame: Up to 24 months

Change in RA-related costs to the insurer

Costs for care of Rheumatoid Arthritis paid by insurer

Time frame: Up to 24 months

Change in serum LDL cholesterol

Elevated Low Density Lipoprotein is strongly associated with heart disease

Time frame: Up to 24 months

Change in serum total cholesterol

Data from ClinicalTrials.gov

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