Patient and Provider Interventions for Managing Osteoarthritis in Primary Care

NCT01435109 | Completed

• 2 other identifiers: Pro00022836R01AR059673
• Study Type: interventional
• Target: 537
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis (OA) is one of the most common chronic conditions and a leading cause of pain and disability among adults. Many adults with OA have significant pain and functional limitations, even though they receive some medical care for their OA. Efforts are needed to help adults improve OA-related outcomes. This study will examine three different approaches for helping adults manage their OA-related symptoms. The study will compare a patient-based intervention (involving exercise, weight management, and cognitive behavioral pain management), a provider-based intervention (involving provision of patient-specific recommendations for care, based on evidence-based guidelines), and a combination of the two interventions, relative to usual care among patients with hip and/or knee osteoarthritis. The interventions are relatively low cost and easy to disseminate, with the patient component being telephone based. This study will provide novel, valuable information of the effectiveness (and cost-effectiveness) of these three interventions in the context of real-world clinical settings.

Conditions

Osteoarthritis

Keywords

Osteoarthritis; Exercise; Diet; Coping Skills; Education, Medical

Outcome Measures

Primary Outcomes (3)

• Change in the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) from Baseline to 12-months.

  Baseline and 12-months

• Change in the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) at 18-months post Baseline.

  post Baseline,18-months

• Change in the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) at 24-months post Baseline.

  post Baseline, 24-months

Secondary Outcomes (2)

• Change in the Short Physical Performance Test Protocol from Baseline to 12-months.

  Baseline and 12-months

• Change in the Patient Health Questionnaire (PHQ-8) from Baseline to 12-months.

  Baseline and 12-months

Study Arms (4)

Usual Care

NO INTERVENTION

Patient Behavioral Intervention

EXPERIMENTAL

Patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.

Behavioral: Patient Behavioral Intervention for OA

Provider Intervention

EXPERIMENTAL

Primary care providers receive patient-specific osteoarthritis information and treatment recommendations at the point of clinical care.

Behavioral: Provider Intervention for OA

Patient and Provider Interventions

EXPERIMENTAL

Patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management; primary care providers receive patient-specific osteoarthritis information and treatment recommendations at the point of clinical care.

Behavioral: Combined Patient and Provider Interventions for OA

Interventions

Patient Behavioral Intervention for OA BEHAVIORAL

Patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.

Patient Behavioral Intervention

Provider Intervention for OA BEHAVIORAL

Primary care providers receive patient-specific osteoarthritis information and treatment recommendations at the point of clinical care.

Provider Intervention

Combined Patient and Provider Interventions for OA BEHAVIORAL

Patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management; primary care providers receive patient-specific osteoarthritis information and treatment recommendations at the point of clinical care.

Patient and Provider Interventions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Radiographic evidence of hip OA and/or radiographic evidence of or meets clinical criteria for knee OA
• Current joint (hip and/or knee) symptoms
• BMI \>= 25
• Physically inactive

You may not qualify if:

• Diagnosis of rheumatoid arthritis, fibromyalgia, or other systemic rheumatic disease
• Diagnosis of a motor neuron disease, Parkinson's disease, multiple sclerosis, or Paget's disease
• Diagnosis of metastatic cancer
• Hospitalized for a stroke, myocardial infarction or coronary artery revascularization in the past 3 months
• On waiting list for or planning arthroplasty
• Total joint replacement (hip or knee) surgery, other hip or knee surgery, meniscus tear (verified by MRI), or ACL tear in the past 6 months
• History of gout in hip or knee
• Quadriplegia or paraplegia
• Active diagnosis of psychosis or serious personality disorder
• Diagnosis of dementia or other memory loss condition
• Current, uncontrolled substance abuse disorder
• Severly impaired speech or hearing (patients must be able to respond to phone calls)
• No access to a telephone
• Inability to understand and speak English
• Blindness

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (3)

• 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: 22530979 BACKGROUND

• Allen KD, Bosworth HB, Chatterjee R, Coffman CJ, Corsino L, Jeffreys AS, Oddone EZ, Stanwyck C, Yancy WS Jr, Dolor RJ. Clinic variation in recruitment metrics, patient characteristics and treatment use in a randomized clinical trial of osteoarthritis management. BMC Musculoskelet Disord. 2014 Dec 6;15:413. doi: 10.1186/1471-2474-15-413.

  PMID: 25481809 BACKGROUND

• Allen KD, Oddone EZ, Coffman CJ, Jeffreys AS, Bosworth HB, Chatterjee R, McDuffie J, Strauss JL, Yancy WS Jr, Datta SK, Corsino L, Dolor RJ. Patient, Provider, and Combined Interventions for Managing Osteoarthritis in Primary Care: A Cluster Randomized Trial. Ann Intern Med. 2017 Mar 21;166(6):401-411. doi: 10.7326/M16-1245. Epub 2017 Jan 17.

  PMID: 28114648 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Motor Activity

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Study Officials

• Kelli D Allen, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2011
• First Posted: September 15, 2011
• Study Start: July 1, 2011
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: June 8, 2016

Record last verified: 2016-06

Locations

US (1)