Knee OsteoarthritisPhase 1/2ENGAGENCT02498847
Occupational Therapy-Delivered Cognitive Behavioral Therapy for Symptomatic Knee Osteoarthritis
A Phase 1/2 study testing ENGAGE in people with Knee Osteoarthritis, run by University of Michigan at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- ENGAGE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2013to Jan 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan Institute of Gerontology
Ann Arbor, Michigan, 48109-2007
University of Michigan
Ann Arbor, Michigan, 48109
About this study
Official title: Occupational Therapy-Delivered Cognitive Behavioral Therapy for Symptomatic Knee Osteoarthritis: A Pilot Study
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- ENGAGE
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENGAGEBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| ENGAGE intervention | Experimental | 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 Receives: Behavioral: ENGAGE |
| Usual Care | No intervention | participated in usual care and received monthly calls to check on health status |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 minutes
Secondary outcomes (3)
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).
Measured: 6 minutes
Pain - Brief Pain Inventory
10 item scale in which participants report their pain severity and interference on a 0 - 10 scale
Measured: 5 minutes
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)
Measured: <5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startMar 2013
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Murphy, University of Michigan
- Investigators
- Susan L Murphy, ScD OTR, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498847
- Sponsor's protocol ID
- HUM00067979
- Acronym
- ENGAGE
- Status last verified
- Apr 2023
- First submitted
- 13 Jul 2015
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Therapy-Delivered Cognitive Behavioral Therapy for Symptomatic Knee Osteoarthritis: A Pilot Study
- ClinicalTrials.gov ID
- NCT02498847
- Acronym / sponsor ID
- ENGAGE / HUM00067979
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 15 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ENGAGE intervention | Experimental | Behavioral: ENGAGE8 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 |
| Usual Care | No intervention | –participated in usual care and received monthly calls to check on health status |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- severe physical impairment
- current cancer treatment
- knee injections or surgery in previous 3 months
- using long-acting narcotics
- shift workers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENGAGEParticipants 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 | Behavioural | ENGAGE intervention |
Primary outcome
Self-Reported Physical Function-WOMAC
Time frame: 5 minutes
Western Ontario and McMaster University Arthritis Index (WOMAC) 17 items, participants rate difficulty in performing different activities on a 0 - 4 scale
3 secondary outcomes
Objective Physical Function- 6 minute walk test
Time frame: 6 minutes
Pain - Brief Pain Inventory
Time frame: 5 minutes
Patient Global Impression of Change
Time frame: <5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
Related trials for Knee Osteoarthritis
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan L Murphy, ScD OTR principal investigator
Associate Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ENGAGE in people with Knee Osteoarthritis, run by University of Michigan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Reported Physical Function-WOMAC (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.