Ignite Creation Date:
2024-05-05 @ 11:51 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01435109
Status:
COMPLETED
Last Update Posted:
2016-06-08
First Post:
2011-09-07
Brief Title:
Patient and Provider Interventions for Managing Osteoarthritis in Primary Care
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Patient and Provider Interventions for Managing Osteoarthritis in Primary Care
Status:
COMPLETED
Status Verified Date:
2016-06
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:
PRIMO
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 andor 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
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 Prior studies have examined strategies for improving patient behaviors to manage OA-related symptoms but few studies have examined provider-based interventions specifically for patients with OA or combinations of patient- and provider-based interventions The objective of this study is to 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 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
This will be a randomized controlled trial involving the following four study arms 1 Patient Behavioral Intervention for OA Only 2 Provider Intervention for OA Only 3 Patient Behavioral Intervention Provider Intervention for OA and 4 Usual Care Control no intervention Approximately 10 primary care practices in the Duke Primary Care Research Consortium PCRC will be randomized to either the Provider Intervention or Provider Control group Within each clinic patients with symptomatic knee andor hip OA n560 total will be randomly assigned to either the Patient Intervention or Patient Control group Participants will be equally allocated between the four study groups with randomization stratified according to gender and race whitenon-white
The patient behavioral 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 All participants in the study will continue with any other usual medical care they receive for OA The provider 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
The primary time point for outcome assessment will be at 12-months The investigators will also assess a limited set of outcomes via telephone at 6-months 18-months and 24-months Following completion of study follow-up assessments participants who were not assigned to one of the two Participant arms will be given the materials for that intervention and health care providers who were not part of one of the two Provider arms will be given the information involved in that intervention 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 four study groups The investigators will also assess the cost-effectiveness of the interventions
This will be a randomized controlled trial involving the following four study arms 1 Patient Behavioral Intervention for OA Only 2 Provider Intervention for OA Only 3 Patient Behavioral Intervention Provider Intervention for OA and 4 Usual Care Control no intervention Approximately 10 primary care practices in the Duke Primary Care Research Consortium PCRC will be randomized to either the Provider Intervention or Provider Control group Within each clinic patients with symptomatic knee andor hip OA n560 total will be randomly assigned to either the Patient Intervention or Patient Control group Participants will be equally allocated between the four study groups with randomization stratified according to gender and race whitenon-white
The patient behavioral 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 All participants in the study will continue with any other usual medical care they receive for OA The provider 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
The primary time point for outcome assessment will be at 12-months The investigators will also assess a limited set of outcomes via telephone at 6-months 18-months and 24-months Following completion of study follow-up assessments participants who were not assigned to one of the two Participant arms will be given the materials for that intervention and health care providers who were not part of one of the two Provider arms will be given the information involved in that intervention 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 four study groups The investigators will also assess the cost-effectiveness of the interventions
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AR059673 | NIH | None | httpsreporternihgovquickSearchR01AR059673 |