Lifestyle Intervention for Rheumatoid Arthritis

Not Applicable

Terminated

• Conditions: Lifestyle Risk Reduction; Rheumatoid Arthritis

• 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.

Study Timeline

• Study First Submitted: 2022-09-17
• Study First Submitted QC: 2022-09-22
• Study First Posted: 2022-09-26
• Study Start: 2023-01-02
• Primary Completion: 2023-01-02
• Study Completion: 2023-01-02
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-02
• Last Update Posted: 2023-08-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 114

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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 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
Change in BMI	Up to 24 months	Body Mass Index change

Trial Locations

Locations (1)

Blue Cross Blue Shield of Vermont; 🇺🇸 Berlin, Vermont, United States