Lifestyle Intervention for Rheumatoid Arthritis
- Conditions
- Lifestyle Risk ReductionRheumatoid Arthritis
- Interventions
- Behavioral: Intensive Lifestyle intervention
- Registration Number
- NCT05554705
- Lead Sponsor
- Blue Cross Blue Shield of Vermont
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 114
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description experimental Intensive Lifestyle intervention standard of care + lifestyle intervention
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change in BMI Up to 24 months Body Mass Index change
Change in weight Up to 24 months Weight change
Change in serum LDL cholesterol Up to 24 months Elevated Low Density Lipoprotein is strongly associated with heart disease
Change in serum HbA1c Up to 24 months Hemoglobin HbA1c is used to assess glucose control in diabetics
Change in dosage of RA-related medications Up to 24 months Dosage of Medications Taken Specifically for Rheumatoid Arthritis
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 blood pressure Up to 24 months Blood pressure change
Change in the number of medications required to treat RA Up to 24 months Number of Medications Taken Specifically for Rheumatoid Arthritis
Change in serum total cholesterol Up to 24 months Elevated total cholesterol is associated with heart disease
Trial Locations
- Locations (1)
Blue Cross Blue Shield of Vermont
🇺🇸Berlin, Vermont, United States