NCT01130740

Brief Summary

Osteoarthritis (OA) is one of the most common chronic conditions and a leading cause of disability among veterans. Many veterans with OA have significant pain and functional limitations, even though they receive some medical care for their OA. Efforts are needed to help veterans to improve OA-related outcomes. This study will examine a comprehensive approach to helping veterans manage their OA-related symptoms, in the context of a VA clinical setting. The study examines an intervention aimed at helping veterans with behaviors that are known to improve OA-related pain and function (such as exercise, weight management, and coping with pain), as well as helping providers to implement evidence-based recommendations for clinical care. The intervention is relatively low cost and easy to disseminate, with the patient component being telephone based. Therefore, if effective, this intervention could be implemented widely across the VA healthcare system.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 26, 2010

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 26, 2015

Completed
Last Updated

April 28, 2015

Status Verified

September 1, 2014

Enrollment Period

2.3 years

First QC Date

May 24, 2010

Results QC Date

November 26, 2014

Last Update Submit

April 6, 2015

Conditions

Osteoarthritis

Keywords

OsteoarthritisExerciseDietCoping SkillsEducation, Medical

Outcome Measures

Primary Outcomes (1)

  • Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)

    Self-report measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items) in the past two weeks. All items are rated on a 5-point Likert scale ranging from "none" (0) to "severe / extreme" (4), for a total of range of 0-96. Higher scores indicate worse symptoms and poorer function. The Mixed Models Analysis described below utilizes a common baseline mean rather than means for the individual arms. This common baseline mean is presented here, and the raw baseline measures per group are presented in the baseline information section.

    12-months

Secondary Outcomes (2)

  • Short Physical Performance Test Protocol

    12-months

  • PHQ-8

    12-months

Study Arms (2)

Arm 1

NO INTERVENTION

usual care

Arm 2

EXPERIMENTAL

Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.

Behavioral: Osteoarthritis Intervention

Interventions

Osteoarthritis InterventionBEHAVIORAL

Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.

Arm 2

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • radiographic evidence of hip OA and / or radiographic of or meets clinical criteria for knee OA
  • current joint symptoms
  • BMI \>=25
  • physically inactive

You may not qualify if:

  • Diagnosis of rheumatoid arthritis, fibromyalgia, or other systemic rheumatic disease
  • Hospitalized for a stroke, myocardial infarction or coronary artery revascularization in the past 3 months
  • Active diagnosis of psychosis or serious personality disorder
  • On waiting list for / planning arthroplasty
  • Severely impaired hearing or speech (patients must be able to respond to phone calls)
  • Unable to speak English
  • No access to a telephone
  • Participating in another OA intervention or other lifestyle change study
  • Dementia or other memory loss condition
  • Current, uncontrolled substance abuse disorder
  • Motor neuron diseases, Parkinson's Disease, multiple sclerosis
  • Quadriplegic or paraplegic
  • Serious / terminal illness as indicated by referral to hospice or palliative care
  • Other self-reported health problem that would prohibit participation in the study
  • Nursing home resident
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

Related Publications (4)

  • Allen KD, Bosworth HB, Brock DS, Chapman JG, Chatterjee R, Coffman CJ, Datta SK, Dolor RJ, Jeffreys AS, Juntilla KA, Kruszewski J, Marbrey LE, McDuffie J, Oddone EZ, Sperber N, Sochacki MP, Stanwyck C, Strauss JL, Yancy WS Jr. Patient and provider interventions for managing osteoarthritis in primary care: protocols for two randomized controlled trials. BMC Musculoskelet Disord. 2012 Apr 24;13:60. doi: 10.1186/1471-2474-13-60.

    PMID: 22530979RESULT

  • Sperber N, Hall KS, Allen K, DeVellis BM, Lewis M, Callahan LF. The role of symptoms and self-efficacy in predicting physical activity change among older adults with arthritis. J Phys Act Health. 2014 Mar;11(3):528-35. doi: 10.1123/jpah.2012-0030. Epub 2013 Feb 8.

    PMID: 23416927RESULT

  • Taylor SS, Hughes JM, Coffman CJ, Jeffreys AS, Ulmer CS, Oddone EZ, Bosworth HB, Yancy WS Jr, Allen KD. Prevalence of and characteristics associated with insomnia and obstructive sleep apnea among veterans with knee and hip osteoarthritis. BMC Musculoskelet Disord. 2018 Mar 9;19(1):79. doi: 10.1186/s12891-018-1993-y.

    PMID: 29523117DERIVED

  • Allen KD, Yancy WS Jr, Bosworth HB, Coffman CJ, Jeffreys AS, Datta SK, McDuffie J, Strauss JL, Oddone EZ. A Combined Patient and Provider Intervention for Management of Osteoarthritis in Veterans: A Randomized Clinical Trial. Ann Intern Med. 2016 Jan 19;164(2):73-83. doi: 10.7326/M15-0378. Epub 2015 Dec 22.

    PMID: 26720751DERIVED

MeSH Terms

Conditions

OsteoarthritisMotor Activity

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Results Point of Contact

Title
Kelli D. Allen, PhD
Organization
Center for Health Services Reserach in Primary Care, Durham VAMC
kelli.allen@va.gov
919-286-0411

Study Officials

  • Kelli Dominick Allen, PhD

    Durham VA Medical Center, Durham, NC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2010

First Posted

May 26, 2010

Study Start

August 1, 2011

Primary Completion

December 1, 2013

Study Completion

January 1, 2014

Last Updated

April 28, 2015

Results First Posted

January 26, 2015

Record last verified: 2014-09

Locations

US(1)