Rheumatoid Arthritis Clinical Trial
Official title:
Mail-Delivered Arthritis Self-Management Education -- Years 1, 2, Carryover
The purpose of this study is twofold, to develop and test the effectiveness of a mailed arthritis self-management education intervention.
Effective self-management education programs for persons with arthritis have been developed,
delivered in various formats, and found effective. Because of limited resources, however,
many state health departments have found dissemination difficult, particularly to vulnerable
populations. Researchers at the University of North Carolina at Chapel Hill and Stanford
University will develop an evidence-based mail-delivered arthritis self-management program
(Arthritis Yes I Can) that is feasible for state health department use and that can be
self-tailored to meet the needs of diverse populations. The study will be conducted in three
phases.
During Phase One (Development) researchers will collaborate with CDC advisors, arthritis
experts from state health departments, and Project consultants to develop the curriculum and
compact disc (CD) and print materials for mail-delivery. We will base Arthritis Yes I Can on
curricula of two evidence-based programs, the Arthritis Self Help Course (ASHC) and the
Chronic Disease Self Management Program (CDSMP), and develop English and Spanish versions.
During Phase Two (Evaluation) we will utilize both a randomized pre-test post-test (four
month) delayed treatment control group design and a longitudinal cohort design to evaluate
program effectiveness. We will recruit 900 individuals, 300 African Americans, 300 other
English speakers, and 300 Spanish speakers, who: 1. Have been diagnosed with osteoarthritis
or rheumatoid arthritis, or meet CDC criteria for chronic joint symptoms; 2. Are at least 18
years of age; and 3. Are able to complete informed consent, enrollment forms, and
interviews/questionnaires. In addition, participants must not have participated in a
previous arthritis self-management program and have access to a CD player. They must be
willing to commit 8-12 hours of self-study over 4-6 weeks. We will use multiple recruitment
methods, emphasizing collaboration with state and local health departments. We will measure:
1. Knowledge of Arthritis and Arthritis Self-Management, 2. Health-related Quality of Life
(Self-reported Health, Pain, Disability, Fatigue, Activity Limitation, Health Distress, and
Depression); 3. Health Care Utilization; 4. Self-Management Behaviors; and 5. Self-Efficacy
for Arthritis Self-Management and Arthritis Helplessness. We will also evaluate participant
satisfaction with mail delivery, and determine the relative success of all recruitment
efforts.
If the intervention is found effective in Phase Two, we will offer guidance to the Arthritis
Program of the Centers for Disease Control and Prevention in adopting and distributing
Arthritis Yes I Can (Phase Three, Dissemination).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04226131 -
MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics
|
N/A | |
Completed |
NCT04171414 -
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT02833350 -
Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
|
Phase 2 | |
Completed |
NCT04255134 -
Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)
|
Phase 4 | |
Recruiting |
NCT05615246 -
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
|
||
Completed |
NCT03248518 -
Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
|
N/A | |
Completed |
NCT03514355 -
MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms
|
N/A | |
Recruiting |
NCT06005220 -
SBD121, a Synbiotic Medical Food for RA Management
|
N/A | |
Recruiting |
NCT05451615 -
Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT05054920 -
Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT02037737 -
Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting
|
N/A | |
Recruiting |
NCT04079374 -
Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel
|
Phase 3 | |
Completed |
NCT02504268 -
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
|
Phase 3 | |
Recruiting |
NCT05496855 -
Remote Care in People With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
Recruiting |
NCT06031415 -
Study of GS-0272 in Participants With Rheumatoid Arthritis
|
Phase 1 | |
Recruiting |
NCT06103773 -
A Study of Single and Multiple Oral Doses of TollB-001
|
Phase 1 | |
Completed |
NCT05999266 -
The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
|
||
Recruiting |
NCT05302934 -
Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
|
||
Recruiting |
NCT04169100 -
Novel Form of Acquired Long QT Syndrome
|
Phase 4 |