Development and Evaluation of A Mailed Arthritis Self-Management Program
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00448474|
Recruitment Status : Completed
First Posted : March 16, 2007
Last Update Posted : March 16, 2007
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Rheumatoid Arthritis||Behavioral: Mailed Arthritis Self-Management Education||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||900 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mail-Delivered Arthritis Self-Management Education -- Years 1, 2, Carryover|
|Study Start Date :||November 2005|
|Study Completion Date :||July 2006|
- Health-related Quality of Life (Self-reported Health, Pain, Disability, Fatigue, Activity Limitation, Health Distress)
- Health Care Utilization
- Self-Management Behaviors
- Self-Efficacy for Arthritis Self-Management
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00448474
|United States, North Carolina|
|University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Jean Goeppinger, PhD, BSN||University of North Carolina, Chapel Hill|
|Principal Investigator:||Kate Lorig, DrPH, BSN||Stanford University|