The Study of Physical Activity Rewards After Knee Surgery
SPARKS
2 other identifiers
interventional
202
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2013
CompletedFirst Posted
Study publicly available on registry
October 28, 2013
CompletedStudy Start
First participant enrolled
January 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 5, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 5, 2016
CompletedJanuary 18, 2018
January 1, 2018
2.8 years
October 23, 2013
January 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of steps
The primary outcome is the average number of steps over 7 days as measured by accelerometer at 6 months post-TKR.
6 months
Secondary Outcomes (1)
Adherence to PA guidelines
6-months
Study Arms (4)
Usual Care
NO INTERVENTIONParticipants randomized to the Usual Care group will receive the current standard post-operative TKR care.
Motivational Interviewing (MI)
ACTIVE COMPARATORParticipants randomized to the MI Intervention group will receive up to 14 telephone calls from a Health Educator for 9 months post-TKR.
Financial Incentives (FI)
ACTIVE COMPARATORParticipants 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.
Motivational Inverterviewing (MI) + Financial Incentives (FI)
ACTIVE COMPARATORParticipants 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.
Interventions
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).
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Related Publications (2)
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.
PMID: 28732147RESULTUsiskin 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.
PMID: 27585441DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elena Losina, PhD
Brigham and Women's Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Co-Director, Orthopaedic and Arthritis Center for Outcomes Research
Study Record Dates
First Submitted
October 23, 2013
First Posted
October 28, 2013
Study Start
January 9, 2014
Primary Completion
November 5, 2016
Study Completion
November 5, 2016
Last Updated
January 18, 2018
Record last verified: 2018-01