Clinical trial NCT05554705: Lifestyle Intervention for Rheumatoid Arthritis
Official title: A Lifestyle Intervention for Rheumatoid Arthritis: Effect of an Intensive Therapeutic Lifestyle Change Program on Inflammatory Markers and Clinical Outcomes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lifestyle Risk Reduction
Rheumatoid Arthritis
Lead sponsor: Blue Cross Blue Shield of Vermont
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in HAQ-2 score
timeFrame: Up to 24 months
measure: Change in serum C-Reactive Protein
timeFrame: Up to 24 months
Secondary outcomes:
measure: Change in dosage of RA-related medications
timeFrame: Up to 24 months
measure: Change in the number of medications required to treat RA
timeFrame: Up to 24 months
measure: Change in RA-related costs for the study participant
timeFrame: Up to 24 months
measure: Change in RA-related costs to the insurer
timeFrame: Up to 24 months
measure: Change in serum LDL cholesterol
timeFrame: Up to 24 months
measure: Change in serum total cholesterol
timeFrame: Up to 24 months
measure: Change in serum HbA1c
timeFrame: Up to 24 months
measure: Change in blood pressure
timeFrame: Up to 24 months
measure: Change in BMI
timeFrame: Up to 24 months
measure: Change in weight
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Berlin
country: United States
facility: Blue Cross Blue Shield of Vermont
state: Vermont
Study officials:
affiliation: Blue Cross Blue Shield of Vermont
name: Keri LeCompte, PharmD
role: PRINCIPAL_INVESTIGATOR
References: