Clinical trial NCT00288912: Self-Management of Osteoarthritis
Official title: Self-Management of Osteoarthritis: A Tailored, Telephone-based Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Self-Care
Telemedicine
Pain
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2006-02-08
Enrollment: 523
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Radiographic evidence of hip or knee osteoarthritis
* Current / persistent joint symptoms (pain, aching, stiffness)

Exclusion Criteria:

* Other rheumatic disease (i.e., rheumatoid arthritis, fibromyalgia)
* Hospitalization for stroke or cardiovascular event within past 3 months
* Metastatic cancer
* Active diagnosis of psychosis
* Terminal illness
* On waiting list for arthroplasty
* Resident of nursing home
* Severely impaired in hearing or speech (participants must be able to respond to phone calls)
* Significant cognitive dysfunction
* No access to a telephone
* Current participation in another interventional study for osteoarthritis

Primary outcomes:
measure: Pain
timeFrame: Baseline and 12-month follow-up
Secondary outcomes:
measure: AIMS 2 Physical Function
timeFrame: Baseline and 12-month follow-up
measure: AIMS 2 Affect
timeFrame: Baseline and 12 months
measure: Arthritis Self Efficacy
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Kelli Dominick Allen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sperber NR, Allen KD, Devellis BM, Devellis RF, Lewis MA, Callahan LF. Differences in effectiveness of the active living every day program for older adults with arthritis. J Aging Phys Act. 2013 Oct;21(4):387-401. doi: 10.1123/japa.21.4.387. Epub 2012 Nov 19.
citation: Sperber NR, Bosworth HB, Coffman CJ, Juntilla KA, Lindquist JH, Oddone EZ, Walker TA, Weinberger M, Allen KD. Participant evaluation of a telephone-based osteoarthritis self-management program, 2006-2009. Prev Chronic Dis. 2012;9:E73. Epub 2012 Mar 22.
citation: Sperber NR, Bosworth HB, Coffman CJ, Lindquist JH, Oddone EZ, Weinberger M, Allen KD. Differences in osteoarthritis self-management support intervention outcomes according to race and health literacy. Health Educ Res. 2013 Jun;28(3):502-11. doi: 10.1093/her/cyt043. Epub 2013 Mar 22.
citation: Allen KD, Oddone EZ, Stock JL, Coffman CJ, Lindquist JH, Juntilla KA, Lemmerman DS, Datta SK, Harrelson ML, Weinberger M, Bosworth HB. The Self-Management of OsteoArthritis in Veterans (SeMOA) Study: design and methodology. Contemp Clin Trials. 2008 Jul;29(4):596-607. doi: 10.1016/j.cct.2007.11.004. Epub 2007 Nov 22.
citation: Allen KD, Oddone EZ, Coffman CJ, Keefe FJ, Lindquist JH, Bosworth HB. Racial differences in osteoarthritis pain and function: potential explanatory factors. Osteoarthritis Cartilage. 2010 Feb;18(2):160-7. doi: 10.1016/j.joca.2009.09.010. Epub 2009 Oct 1.
citation: Allen KD, Oddone EZ, Coffman CJ, Datta SK, Juntilla KA, Lindquist JH, Walker TA, Weinberger M, Bosworth HB. Telephone-based self-management of osteoarthritis: A randomized trial. Ann Intern Med. 2010 Nov 2;153(9):570-9. doi: 10.7326/0003-4819-153-9-201011020-00006.