Lifestyle Intervention for Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05554705
• Other study ID #: 22-08-629-1275
• Status: Terminated
• Phase: N/A
• Start date: January 2, 2023
• Est. completion date: January 2, 2023

Study information

• Verified date: August 2023
• Source: Blue Cross Blue Shield of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 114
• Est. completion date: January 2, 2023
• Est. primary completion date: January 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Lifestyle Risk Reduction
• Rheumatoid Arthritis

Intervention

Behavioral:
• Intensive Lifestyle intervention
12 week therapeutic lifestyle change program

Locations

Country	Name	City	State
United States	Blue Cross Blue Shield of Vermont	Berlin	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
Blue Cross Blue Shield of Vermont

Country where clinical trial is conducted

United States, 

Outcome

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