Lifestyle Risk Reduction, Rheumatoid Arthritis
Conditions
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.
Interventions
BEHAVIORALIntensive Lifestyle intervention
12 week therapeutic lifestyle change program
Sponsors
Blue Cross Blue Shield of Vermont
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HAQ-2 score | Up to 24 months | 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. |
| Change in serum C-Reactive Protein | Up to 24 months | CRP is a reliable marker of acute and chronic inflammation (Sproston and Ashworth, 2018). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in RA-related costs for the study participant | Up to 24 months | Out of Pocket costs related to Rheumatoid Arthritis Care |
| Change in RA-related costs to the insurer | Up to 24 months | Costs for care of Rheumatoid Arthritis paid by insurer |
| Change in serum LDL cholesterol | Up to 24 months | Elevated Low Density Lipoprotein is strongly associated with heart disease |
| Change in serum total cholesterol | Up to 24 months | Elevated total cholesterol is associated with heart disease |
| Change in dosage of RA-related medications | Up to 24 months | Dosage of Medications Taken Specifically for Rheumatoid Arthritis |
| Change in blood pressure | Up to 24 months | Blood pressure change |
| Change in BMI | Up to 24 months | Body Mass Index change |
| Change in weight | Up to 24 months | Weight change |
| Change in serum HbA1c | Up to 24 months | Hemoglobin HbA1c is used to assess glucose control in diabetics |
| Change in the number of medications required to treat RA | Up to 24 months | Number of Medications Taken Specifically for Rheumatoid Arthritis |
Countries
United States
Outcome results
None listed