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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00288912 |
The purpose of this study is to examine whether a telephone-based self-management intervention improves pain, physical function, and other outcomes among veterans with osteoarthritis of the hip or knee.
Condition | Intervention |
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Osteoarthritis |
Behavioral: Health Education Behavioral: Osteoarthritis Self-Management |
Study Type: | Interventional |
Study Design: | Active Control, Efficacy Study, Randomized, Single Blind (Outcomes Assessor), Single Group Assignment |
Official Title: | Self-Management of Osteoarthritis: A Tailored, Telephone-Based Intervention |
Enrollment: | 524 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Health Education Intervention
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Behavioral: Health Education
12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics.
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2: No Intervention
Usual Medical Care
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3: Experimental
Osteoarthritis Self-Management
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Behavioral: Osteoarthritis Self-Management
12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis.
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Background / Rationale: Osteoarthritis (OA) is the one of the most common chronic conditions among veterans, and over half of VA health care users with OA report being limited in their daily activities because of joint symptoms. However, studies have not examined interventions to improve outcomes or quality of care among the large and growing number of veterans with OA. Telephone-based self-management interventions may be a cost-effective way to improve pain, physical function, and other outcomes in this patient population. Objective: The purpose of this study is to examine the effectiveness of a one-year telephone-based self-management intervention for veterans with hip or knee OA. The primary hypothesis is that the self-management intervention will result in a greater reduction in pain as compared to both usual care and attention control conditions. Methods: This will be a randomized control trial of 519 veterans at the Durham VAMC who have radiographic evidence and a physician diagnosis of OA of the hip or knee. Participants will be equally allocated to self-management, attention control, and usual care groups. The self-management intervention is designed to provide participants with key information about OA and its treatment and to enhance participants' self-efficacy for managing OA-related symptoms. This intervention will involve provision of written, audio, and video educational materials, as well as monthly telephone calls by a nurse. The nurse will guide participants in developing personal OA-related goals, as well as specific plans for meeting these goals. Other strategies for enhancing self-efficacy will include modeling and mastery of self-management behaviors, persuasion to adopt these behaviors, and reinterpretation of OA symptoms. The attention control group will receive written materials on health screening related topics (not OA-related), and the nurse will call participants on a monthly basis to discuss these materials. The primary outcome measure for this study will be self-reported pain (Arthritis Impact Measurement-2 (AIMS2) subscale), and secondary outcomes will be self-reported function (AIMS2 subscale), affect (AIMS2 subscale), and arthritis specific self-efficacy. Outcomes will be measured at baseline and following the one-year study period. Analysis of covariance will be used to compare primary and secondary outcomes between the intervention group and each of the control groups, adjusting for baseline measures, participant demographic and clinical characteristics. We will also examine the cost-effectiveness of the intervention. Impact: This study is significant because it examines a highly prevalent but understudied chronic illness among veterans. In addition, this OA self-management program will contribute to the VA health care system's specific mission to improve pain management through patient education and participation. The proposed self-management intervention will be low-cost and easy to disseminate within the VA health care system. Therefore it may be an important tool for improving outcomes, especially pain, among many veterans with OA.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Department of Veterans Affairs ( Allen, Kelli - Principal Investigator ) |
Study ID Numbers: | IIR 04-016 |
Study First Received: | February 6, 2006 |
Last Updated: | January 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00288912 History of Changes |
Health Authority: | United States: Federal Government |
Pain Self-Care Telemedicine Veterans |
Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Pain Rheumatic Diseases |
Musculoskeletal Diseases Osteoarthritis Joint Diseases Arthritis Rheumatic Diseases |