Lifestyle Intervention for Rheumatoid Arthritis

NCT05554705 | Terminated DMC

• 1 other identifier: 22-08-629-1275
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Lifestyle Risk Reduction; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (10)

• Change in dosage of RA-related medications

  Up to 24 months

• Change in the number of medications required to treat RA

  Up to 24 months

• Change in RA-related costs for the study participant

  Up to 24 months

• Change in RA-related costs to the insurer

  Up to 24 months

• Change in serum LDL cholesterol

  Up to 24 months

Study Arms (2)

experimental

EXPERIMENTAL

standard of care + lifestyle intervention

Behavioral: Intensive Lifestyle intervention

control

NO INTERVENTION

no intervention (control group)

Interventions

Intensive Lifestyle intervention BEHAVIORAL

12 week therapeutic lifestyle change program

experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Blue Cross Blue Shield of Vermont: lead

Study Sites (1)

Blue Cross Blue Shield of Vermont

Berlin Corners, Vermont, 05602, United States

Location

MeSH Terms

Conditions

Risk Reduction Behavior; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Behavior; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Keri LeCompte, PharmD

  Blue Cross Blue Shield of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2022
• First Posted: September 26, 2022
• Study Start: January 2, 2023
• Primary Completion: January 2, 2023
• Study Completion: January 2, 2023
• Last Updated: August 4, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)