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Lifestyle Intervention for Rheumatoid Arthritis

Primary Purpose

Lifestyle Risk Reduction, Rheumatoid Arthritis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intensive Lifestyle intervention
Sponsored by
Blue Cross Blue Shield of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lifestyle Risk Reduction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Blue Cross Blue Shield of Vermont

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experimental

control

Arm Description

standard of care + lifestyle intervention

no intervention (control group)

Outcomes

Primary Outcome Measures

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.
Change in serum C-Reactive Protein
CRP is a reliable marker of acute and chronic inflammation (Sproston and Ashworth, 2018).

Secondary Outcome Measures

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

Full Information

First Posted
September 17, 2022
Last Updated
August 2, 2023
Sponsor
Blue Cross Blue Shield of Vermont
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1. Study Identification

Unique Protocol Identification Number
NCT05554705
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Lost necessary staff support
Study Start Date
January 2, 2023 (Actual)
Primary Completion Date
January 2, 2023 (Actual)
Study Completion Date
January 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Blue Cross Blue Shield of Vermont

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lifestyle Risk Reduction, Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental
Arm Type
Experimental
Arm Description
standard of care + lifestyle intervention
Arm Title
control
Arm Type
No Intervention
Arm Description
no intervention (control group)
Intervention Type
Behavioral
Intervention Name(s)
Intensive Lifestyle intervention
Intervention Description
12 week therapeutic lifestyle change program
Primary Outcome Measure Information:
Title
Change in HAQ-2 score
Description
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.
Time Frame
Up to 24 months
Title
Change in serum C-Reactive Protein
Description
CRP is a reliable marker of acute and chronic inflammation (Sproston and Ashworth, 2018).
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Change in dosage of RA-related medications
Description
Dosage of Medications Taken Specifically for Rheumatoid Arthritis
Time Frame
Up to 24 months
Title
Change in the number of medications required to treat RA
Description
Number of Medications Taken Specifically for Rheumatoid Arthritis
Time Frame
Up to 24 months
Title
Change in RA-related costs for the study participant
Description
Out of Pocket costs related to Rheumatoid Arthritis Care
Time Frame
Up to 24 months
Title
Change in RA-related costs to the insurer
Description
Costs for care of Rheumatoid Arthritis paid by insurer
Time Frame
Up to 24 months
Title
Change in serum LDL cholesterol
Description
Elevated Low Density Lipoprotein is strongly associated with heart disease
Time Frame
Up to 24 months
Title
Change in serum total cholesterol
Description
Elevated total cholesterol is associated with heart disease
Time Frame
Up to 24 months
Title
Change in serum HbA1c
Description
Hemoglobin HbA1c is used to assess glucose control in diabetics
Time Frame
Up to 24 months
Title
Change in blood pressure
Description
Blood pressure change
Time Frame
Up to 24 months
Title
Change in BMI
Description
Body Mass Index change
Time Frame
Up to 24 months
Title
Change in weight
Description
Weight change
Time Frame
Up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keri LeCompte, PharmD
Organizational Affiliation
Blue Cross Blue Shield of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
Blue Cross Blue Shield of Vermont
City
Berlin
State/Province
Vermont
ZIP/Postal Code
05602
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Lifestyle Intervention for Rheumatoid Arthritis

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