The Study of Physical Activity Rewards After Knee Surgery

NCT ID: NCT01970631

Last Updated: 2018-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-09
• Study Completion Date: 2016-11-05

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.

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.

Conditions

Osteoarthritis; Degenerative Joint Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Usual Care

Participants randomized to the Usual Care group will receive the current standard post-operative TKR care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Motivational Interviewing (MI)

Intervention Type: BEHAVIORAL

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).

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.

Group Type: ACTIVE_COMPARATOR

Financial Incentives

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Motivational Interviewing (MI)

Intervention Type: BEHAVIORAL

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).

Financial Incentives

Intervention Type: OTHER

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.

Interventions

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).

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Elena Losina

Co-Director, Orthopaedic and Arthritis Center for Outcomes Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elena Losina, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

References

Losina E, Collins JE, Deshpande BR, Smith SR, Michl GL, Usiskin IM, Klara KM, Winter AR, Yang HY, Selzer F, Katz JN. Financial Incentives and Health Coaching to Improve Physical Activity Following Total Knee Replacement: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2018 May;70(5):732-740. doi: 10.1002/acr.23324. Epub 2018 Apr 12.

Reference Type: RESULT

PMID: 28732147 (View on PubMed)

Usiskin IM, Yang HY, Deshpande BR, Collins JE, Michl GL, Smith SR, Klara KM, Selzer F, Katz JN, Losina E. Association between activity limitations and pain in patients scheduled for total knee arthroplasty. BMC Musculoskelet Disord. 2016 Sep 1;17(1):378. doi: 10.1186/s12891-016-1233-2.

Reference Type: DERIVED

PMID: 27585441 (View on PubMed)

Other Identifiers

R21AR063913

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2013P000916

Identifier Type: -

Identifier Source: org_study_id