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Lost necessary staff support
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental | Experimental | standard of care + lifestyle intervention |
|
| control | No Intervention | no intervention (control group) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Lifestyle intervention | Behavioral | 12 week therapeutic lifestyle change program |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in dosage of RA-related medications | Dosage of Medications Taken Specifically for Rheumatoid Arthritis | Up to 24 months |
| Change in the number of medications required to treat RA | Number of Medications Taken Specifically for Rheumatoid Arthritis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keri LeCompte, PharmD | Blue Cross Blue Shield of Vermont | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blue Cross Blue Shield of Vermont | Berlin Corners | Vermont | 05602 | United States |
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| ID | Term |
|---|---|
| D040242 | Risk Reduction Behavior |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Up to 24 months |
| Change in RA-related costs for the study participant | Out of Pocket costs related to Rheumatoid Arthritis Care | Up to 24 months |
| Change in RA-related costs to the insurer | Costs for care of Rheumatoid Arthritis paid by insurer | Up to 24 months |
| Change in serum LDL cholesterol | Elevated Low Density Lipoprotein is strongly associated with heart disease | Up to 24 months |
| Change in serum total cholesterol | Elevated total cholesterol is associated with heart disease | Up to 24 months |
| Change in serum HbA1c | Hemoglobin HbA1c is used to assess glucose control in diabetics | Up to 24 months |
| Change in blood pressure | Blood pressure change | Up to 24 months |
| Change in BMI | Body Mass Index change | Up to 24 months |
| Change in weight | Weight change | Up to 24 months |
| D012216 |
| Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |