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Occupational Therapy-Delivered Cognitive Behavioral Therapy for Symptomatic Knee Osteoarthritis (ENGAGE)

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ENGAGE
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • community-living
  • report of at least mild to moderate pain in knee with osteoarthritis
  • clinical determination of knee osteoarthritis
  • report of knee pain for > 3 months duration
  • ambulatory with or without cane or walker
  • has internet access and can use computer

Exclusion Criteria:

  • severe physical impairment
  • current cancer treatment
  • knee injections or surgery in previous 3 months
  • using long-acting narcotics
  • shift workers
  • participation in rehabilitation or behavioral therapy for OA in the previous year

Sites / Locations

  • University of Michigan Institute of Gerontology
  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ENGAGE intervention

Usual Care

Arm Description

8 in-person weekly treatment sessions with an occupational therapist of 30 minutes - 1 hour duration intervention content provided on website, homework assigned each week after intervention period, monthly calls conducted to check on health status

participated in usual care and received monthly calls to check on health status

Outcomes

Primary Outcome Measures

Self-Reported Physical Function-WOMAC
Western Ontario and McMaster University Arthritis Index (WOMAC) 17 items, participants rate difficulty in performing different activities on a 0 - 4 scale

Secondary Outcome Measures

Objective Physical Function- 6 minute walk test
The 6 minute walk test involves walking at usual pace for 6 minutes over a flat surface. Overall distance is recorded (in feet).
Pain - Brief Pain Inventory
10 item scale in which participants report their pain severity and interference on a 0 - 10 scale
Patient Global Impression of Change
Participant answers one question. Overall how do you feel since you started participating in this study? on a scale of very much improved (1) - very much worse (7)

Full Information

First Posted
July 13, 2015
Last Updated
April 18, 2023
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT02498847
Brief Title
Occupational Therapy-Delivered Cognitive Behavioral Therapy for Symptomatic Knee Osteoarthritis
Acronym
ENGAGE
Official Title
Occupational Therapy-Delivered Cognitive Behavioral Therapy for Symptomatic Knee Osteoarthritis: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Knee osteoarthritis (OA) affects 27 million US adults and is a leading cause of pain and disability. Non-pharmacological interventions are recommended but are underutilized. Exercise reduces pain and improves physical function, but benefits tend to wane without a component to facilitate behavior change. Cognitive behavioral therapy (CBT) has long term benefits on pain and physical function in individuals with OA, but is not typically offered in clinical care. CBT could be taught in the context of clinical care by occupational therapists (OT). OTs help people manage chronic conditions by teaching behavioral strategies that promote health and function. The purpose of this study is to test the feasibility and efficacy of an OT-delivered cognitive behavioral therapy program to help people manage their knee OA.
Detailed Description
Knee OA, in particular, is a major driver of health care costs and is also a leading cause of arthritis-related activity limitations. A common assumption in knee OA treatment is that relief of joint pain will lead to improvements in physical function. However, many factors can influence disability in OA, not only the biomechanical factors which have been the focus of traditional rehabilitation. Although research supports a broader biopsychosocial approach to knee OA treatment, it has not been broadly adopted into clinical treatments. The biopsychosocial model posits that pain and disability are not only affected by pathophysical (e.g., biological) factors, but also psychological (e.g., depression, coping, self-efficacy) and social factors (e.g., social support, response of significant other). One approach to offering psychosocial aspects in the context of pain treatment has been via CBT, a common psychosocial intervention, with evidence supporting its efficacy in OA. Despite the evidence, CBT is rarely integrated into actual clinical practice for people with knee OA. Barriers to integration have included limited access to psychologists (particularly in rural settings), difficulties coordinating primary care physicians with psychological practices, inconsistent reimbursement of psychological services for OA pain, and inconsistent standardization of treatments across settings. The current study aims to overcome barriers that have previously limited access to a biopsychosocial approach to knee OA treatments by integrating cognitive and behaviorally-based self-management training into a new rehabilitation intervention offered through occupational therapy, an allied medical field which commonly teaches behavioral strategies to improve physical function in many clinical populations. Because this approach will be manualized, it will provide the opportunity for easy adoption into clinical practice.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ENGAGE intervention
Arm Type
Experimental
Arm Description
8 in-person weekly treatment sessions with an occupational therapist of 30 minutes - 1 hour duration intervention content provided on website, homework assigned each week after intervention period, monthly calls conducted to check on health status
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
participated in usual care and received monthly calls to check on health status
Intervention Type
Behavioral
Intervention Name(s)
ENGAGE
Intervention Description
Participants are introduced to ENGAGE program by the study OT. The ENGAGE program is located on a website and has several modules. The modules include a video in which a health provider is featured. This health provider gives a short presentation on a topic related to OA, symptom management or lifestyle change. Within each module, there is downloadable homework and additional information which can be printed. The modules are: What is Osteoarthritis? Information about treatments Exercise Sleep hygiene Relaxation Pleasant Activity Scheduling Goal setting Problem Solving Pacing Communication
Primary Outcome Measure Information:
Title
Self-Reported Physical Function-WOMAC
Description
Western Ontario and McMaster University Arthritis Index (WOMAC) 17 items, participants rate difficulty in performing different activities on a 0 - 4 scale
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Objective Physical Function- 6 minute walk test
Description
The 6 minute walk test involves walking at usual pace for 6 minutes over a flat surface. Overall distance is recorded (in feet).
Time Frame
6 minutes
Title
Pain - Brief Pain Inventory
Description
10 item scale in which participants report their pain severity and interference on a 0 - 10 scale
Time Frame
5 minutes
Title
Patient Global Impression of Change
Description
Participant answers one question. Overall how do you feel since you started participating in this study? on a scale of very much improved (1) - very much worse (7)
Time Frame
<5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: community-living report of at least mild to moderate pain in knee with osteoarthritis clinical determination of knee osteoarthritis report of knee pain for > 3 months duration ambulatory with or without cane or walker has internet access and can use computer Exclusion Criteria: severe physical impairment current cancer treatment knee injections or surgery in previous 3 months using long-acting narcotics shift workers participation in rehabilitation or behavioral therapy for OA in the previous year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan L Murphy, ScD OTR
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Institute of Gerontology
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-2007
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Occupational Therapy-Delivered Cognitive Behavioral Therapy for Symptomatic Knee Osteoarthritis

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