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The Study of Physical Activity Rewards After Knee Surgery (SPARKS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01970631
Recruitment Status : Completed
First Posted : October 28, 2013
Last Update Posted : January 18, 2018
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Elena Losina, Brigham and Women's Hospital

Brief Summary:
The objectives of this research are to conduct a proof of concept randomized controlled trial with 200 patients undergoing primary total knee replacement (TKR) at Brigham and Women's Hospital (BWH). The trial will compare levels of physical activity in subjects in the behavioral and economic interventions versus "Usual Care" post TKR.

Condition or disease Intervention/treatment Phase
Osteoarthritis Degenerative Joint Disease Behavioral: Motivational Interviewing (MI) Other: Financial Incentives Not Applicable

Detailed Description:

Physical activity (PA) has been shown to improve pain and function in persons with knee osteoarthritis (OA), reduce obesity, and prevent the onset and progression of heart disease, diabetes, and chronic pulmonary disease. The US Department of Human and Health Services (DHHS) guidelines recommend that adults engage in >150 minutes of moderate physical activity per week. However, adherence to PA guidelines is poor in the general population, particularly in persons with knee OA.

Total knee replacement (TKR) is widely used in patients with symptomatic, advanced knee OA. While the vast majority of persons undergoing TKR experience considerable reduction in pain and improvement in functional capacity, far fewer take this opportunity to become more physically active. Since physical activity has a direct relationship with quality of life and with prevention and amelioration of many chronic conditions, many TKR recipients do not derive maximum benefits from the procedure.

The focus of this proposal is to conduct a proof of concept RCT to establish the efficacy of a behavioral economics-based intervention that would facilitate engagement in physical activity and improve adherence to PA guidelines in the growing population of TKR recipients. We address the innovative hypothesis that the period following TKR presents a window of opportunity to fundamentally change attitudes and beliefs regarding PA, and that tangible economic incentives will effectively induce behavior change and facilitate adherence to PA guidelines.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Actual Study Start Date : January 9, 2014
Actual Primary Completion Date : November 5, 2016
Actual Study Completion Date : November 5, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Usual Care
Participants randomized to the Usual Care group will receive the current standard post-operative TKR care.
Active Comparator: Motivational Interviewing (MI)
Participants randomized to the MI Intervention group will receive up to 14 telephone calls from a Health Educator for 9 months post-TKR.
Behavioral: Motivational Interviewing (MI)
The motivational interviewing arms of SPARKS will consist of Health Educators trained in Motivational Interviewing (MI) techniques contacting participants at regular intervals over the course of the nine months following participants' total knee replacement (TKR).

Active Comparator: Financial Incentives (FI)
Participants randomized to the FI Intervention group will receive financial incentives for completing physical activity logs weekly/bi-weekly and achieving pre-specified physical activity goals over the course of the study.
Other: Financial Incentives
The financial intervention arms of SPARKS will provide compensation to participants for completing physical activity logs weekly/bi-weekly and reaching pre-specified physical activity goals.

Active Comparator: Motivational Inverterviewing (MI) + Financial Incentives (FI)
Participants randomized to the FI + MI Intervention group will receive financial incentives for completing physical activity logs weekly/bi-weekly and achieving pre-specified physical activity goals as well as receive up to 14 telephone calls from a Health Educator for 9 months post-TKR.
Behavioral: Motivational Interviewing (MI)
The motivational interviewing arms of SPARKS will consist of Health Educators trained in Motivational Interviewing (MI) techniques contacting participants at regular intervals over the course of the nine months following participants' total knee replacement (TKR).

Other: Financial Incentives
The financial intervention arms of SPARKS will provide compensation to participants for completing physical activity logs weekly/bi-weekly and reaching pre-specified physical activity goals.




Primary Outcome Measures :
  1. number of steps [ Time Frame: 6 months ]
    The primary outcome is the average number of steps over 7 days as measured by accelerometer at 6 months post-TKR.


Secondary Outcome Measures :
  1. Adherence to PA guidelines [ Time Frame: 6-months ]
    The secondary outcome will be adherence to PA guidelines, defined by the DHHS as >150 minutes of moderate or greater intensity PA occurring in bouts of 10 minutes or more per week.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled to undergo primary TKA at BWH
  • Osteoarthritis is the principal underlying diagnosis
  • Age >=40 at the projected date of TKA
  • English-speaking
  • Willing and able to access the internet to complete study related questionnaires

Exclusion Criteria:

  • Osteoarthritis is not the principal underlying diagnosis (e.g. inflammatory arthritis)
  • Dementia (can not fill out forms)
  • Psychological issues that preclude participation, as identified by participating surgeons
  • Does not have access to a computer and/or the internet.
  • Non-English speaker (instruments are not validated in Spanish); very few non-English speakers (<5%) are otherwise eligible
  • Age <40 at the projected date of TKA (TKA is usually due to major trauma, juvenile onset or congenital disease)
  • Lives in a nursing home (difficult to track costs)
  • Implantation of Unicompartamental Knee Arthroscopy (different clinical features and different costs)
  • Bilateral TKA in same admission (simultaneous), staged or within 6 months
  • Uses a wheelchair or walker to ambulate
  • Has been told by a physician that he/she has a heart condition and should only do physical activity recommended by a doctor
  • Has pain in his/her chest when doing physical activity
  • Loses balance because of dizziness
  • Loses consciousness
  • Unable/unwilling to wear Fitbit® accelerometer for 5 or more days during baseline visit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01970631


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
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Principal Investigator: Elena Losina, PhD Brigham and Women's Hospital

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Elena Losina, Co-Director, Orthopaedic and Arthritis Center for Outcomes Research, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01970631    
Other Study ID Numbers: 2013P000916
R21AR063913 ( U.S. NIH Grant/Contract )
First Posted: October 28, 2013    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Keywords provided by Elena Losina, Brigham and Women's Hospital:
Osteoarthritis
Total Knee Replacement
total Knee Arthroplasty
Post-operative recovery TKR
Physical Activity
Motivational Interviewing
Financial Incentives
Additional relevant MeSH terms:
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Osteoarthritis
Joint Diseases
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases