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

Primary Purpose

Osteoarthritis, Degenerative Joint Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing (MI)
Financial Incentives
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis focused on measuring Osteoarthritis, Total Knee Replacement, total Knee Arthroplasty, Post-operative recovery TKR, Physical Activity, Motivational Interviewing, Financial Incentives

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Active Comparator

Active Comparator

Arm Label

Usual Care

Motivational Interviewing (MI)

Financial Incentives (FI)

Motivational Inverterviewing (MI) + Financial Incentives (FI)

Arm Description

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

Participants randomized to the MI Intervention group will receive up to 14 telephone calls from a Health Educator for 9 months post-TKR.

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.

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.

Outcomes

Primary Outcome Measures

number of steps
The primary outcome is the average number of steps over 7 days as measured by accelerometer at 6 months post-TKR.

Secondary Outcome Measures

Adherence to PA guidelines
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.

Full Information

First Posted
October 23, 2013
Last Updated
January 16, 2018
Sponsor
Brigham and Women's Hospital
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT01970631
Brief Title
The Study of Physical Activity Rewards After Knee Surgery
Acronym
SPARKS
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 9, 2014 (Actual)
Primary Completion Date
November 5, 2016 (Actual)
Study Completion Date
November 5, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Degenerative Joint Disease
Keywords
Osteoarthritis, Total Knee Replacement, total Knee Arthroplasty, Post-operative recovery TKR, Physical Activity, Motivational Interviewing, Financial Incentives

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants randomized to the Usual Care group will receive the current standard post-operative TKR care.
Arm Title
Motivational Interviewing (MI)
Arm Type
Active Comparator
Arm Description
Participants randomized to the MI Intervention group will receive up to 14 telephone calls from a Health Educator for 9 months post-TKR.
Arm Title
Financial Incentives (FI)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Motivational Inverterviewing (MI) + Financial Incentives (FI)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing (MI)
Intervention Description
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
Other
Intervention Name(s)
Financial Incentives
Intervention Description
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 Measure Information:
Title
number of steps
Description
The primary outcome is the average number of steps over 7 days as measured by accelerometer at 6 months post-TKR.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Adherence to PA guidelines
Description
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.
Time Frame
6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Losina, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28732147
Citation
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.
Results Reference
result
PubMed Identifier
27585441
Citation
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.
Results Reference
derived

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The Study of Physical Activity Rewards After Knee Surgery

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