Ignite Creation Date:
2024-05-05 @ 10:34 PM
Last Modification Date:
2024-10-26 @ 10:20 AM
Study NCT ID:
NCT01130740
Status:
COMPLETED
Last Update Posted:
2015-04-28
First Post:
2010-05-24
Brief Title:
Patient and Provider Interventions for Managing Osteoarthritis in Primary Care
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Patient and Provider Interventions for Managing Osteoarthritis in Primary Care
Status:
COMPLETED
Status Verified Date:
2014-09
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:
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
Detailed Description:
Evidence-based guidelines emphasize that adequate management of osteoarthritis OA requires a combination of both medical and behavioral modalities However many of the recommended guidelines are not regularly incorporated into clinical practice and the recommended behavioral strategies eg exercise and weight management are not practiced by most patients The objective of this study is examine the effectiveness of a combined intervention for patients involving exercise weight management and cognitive behavioral pain management and providers involving provision of patient-specific recommendations for care based on evidence-based guidelines for improving OA-related outcomes in a real-world VA clinical setting To our knowledge this is will be the first study to intervene at a both the patient and provider levels for managing OA
This will be a randomized controlled trial of n300 patients with symptomatic knee or hip OA with equal assignment to 2 study arms 1 Patient and Provider Intervention for OA and 2 Usual Care Control We will randomize 30 primary care providers at the Durham VAMC and affiliated community based outpatient clinics to either intervention or control groups We will then enroll 10 patients from each provider 5 White 5 Non-White The patient component of the intervention will be a twelve-month program that includes the following elements written educational materials focused on exercise weight management and cognitive behavioral pain management an exercise video tailored for patients with lower extremity OA and telephone calls by a counselor to support behavior change The provider component of the intervention will involve giving information on patients OA symptoms and treatment as well as patient-specific evidence-based recommendations for care Providers will have access to this information as well as facilitated referrals for patient-specific treatment recommendations eg physical therapy orthopedics at the point of clinical care via electronic medical records The primary time point for outcome assessment will be at 12-months We will also assess a limited set of outcomes via telephone at 6-months The primary outcome will be the Western Ontario and McMasters Universities Osteoarthritis Index WOMAC Secondary outcomes will include objective physical function Short Physical Performance Test and depressive symptoms PHQ-8 The main study analyses will compare outcomes between the intervention and control groups We will also assess the cost-effectiveness of the intervention
This will be a randomized controlled trial of n300 patients with symptomatic knee or hip OA with equal assignment to 2 study arms 1 Patient and Provider Intervention for OA and 2 Usual Care Control We will randomize 30 primary care providers at the Durham VAMC and affiliated community based outpatient clinics to either intervention or control groups We will then enroll 10 patients from each provider 5 White 5 Non-White The patient component of the intervention will be a twelve-month program that includes the following elements written educational materials focused on exercise weight management and cognitive behavioral pain management an exercise video tailored for patients with lower extremity OA and telephone calls by a counselor to support behavior change The provider component of the intervention will involve giving information on patients OA symptoms and treatment as well as patient-specific evidence-based recommendations for care Providers will have access to this information as well as facilitated referrals for patient-specific treatment recommendations eg physical therapy orthopedics at the point of clinical care via electronic medical records The primary time point for outcome assessment will be at 12-months We will also assess a limited set of outcomes via telephone at 6-months The primary outcome will be the Western Ontario and McMasters Universities Osteoarthritis Index WOMAC Secondary outcomes will include objective physical function Short Physical Performance Test and depressive symptoms PHQ-8 The main study analyses will compare outcomes between the intervention and control groups We will also assess the cost-effectiveness of the intervention
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