Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448474
Status:
COMPLETED
Last Update Posted:
2007-03-16
First Post:
2007-03-14
Brief Title:
Development and Evaluation of A Mailed Arthritis Self-Management Program
Sponsor:
University of North Carolina
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Mail-Delivered Arthritis Self-Management Education -- Years 1 2 Carryover
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is twofold to develop and test the effectiveness of a mailed arthritis self-management education intervention
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 interviewsquestionnaires 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
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 interviewsquestionnaires 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None