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Development and Evaluation of A Mailed Arthritis Self-Management Program

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00448474
First Posted: March 16, 2007
Last Update Posted: March 16, 2007
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.
Collaborators:
Stanford University
Centers for Disease Control and Prevention
Information provided by:
University of North Carolina, Chapel Hill
  Purpose
The purpose of this study is twofold, to develop and test the effectiveness of a mailed arthritis self-management education intervention.

Condition Intervention
Osteoarthritis Rheumatoid Arthritis Behavioral: Mailed Arthritis Self-Management Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: Mail-Delivered Arthritis Self-Management Education -- Years 1, 2, Carryover

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 900
Study Start Date: November 2005
Estimated Study Completion Date: July 2006
Detailed Description:

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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Report MD diagnosis of osteoarthritis or rheumatoid arthritis, or meet CDC criteria for chronic joint symptoms
  • Are at least 18 years of age
  • Are able to complete informed consent, enrollment forms, and interviews/questionnaires
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina
Stanford University
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Jean Goeppinger, PhD, BSN University of North Carolina, Chapel Hill
Principal Investigator: Kate Lorig, DrPH, BSN Stanford University
  More Information

ClinicalTrials.gov Identifier: NCT00448474     History of Changes
Other Study ID Numbers: 05-1163-1-3
First Submitted: March 14, 2007
First Posted: March 16, 2007
Last Update Posted: March 16, 2007
Last Verified: March 2007

Keywords provided by University of North Carolina, Chapel Hill:
Disease self-management
Community program

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases