OsteoarthritisSPARKSNCT01970631
The Study of Physical Activity Rewards After Knee Surgery
A study testing Motivational Interviewing (MI) and Financial Incentives in people with Osteoarthritis and Degenerative Joint Disease, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Degenerative Joint Disease
- What is being tested?
- Motivational Interviewing (MI) and Financial Incentives
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2014to 5 Nov 2016
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the 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
- Being tested
- Motivational Interviewing (MI), Financial Incentives
- Keywords
- Osteoarthritis, Total Knee Replacement, total Knee Arthroplasty, Post-operative recovery TKR, Physical Activity, Motivational Interviewing, Financial Incentives
- Medical subject headings
- Osteoarthritis, Joint Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing (MI)Behavioural
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 IncentivesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Participants randomized to the Usual Care group will receive the current standard post-operative TKR care. |
| Motivational Interviewing (MI) | Active comparator | Participants randomized to the MI Intervention group will receive up to 14 telephone calls from a Health Educator for 9 months post-TKR. Receives: Behavioral: Motivational Interviewing (MI) |
| Financial Incentives (FI) | Active comparator | 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. Receives: Other: Financial Incentives |
| Motivational Inverterviewing (MI) + Financial Incentives (FI) | Active comparator | 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. Receives: Behavioral: Motivational Interviewing (MI); Other: Financial Incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of steps
The primary outcome is the average number of steps over 7 days as measured by accelerometer at 6 months post-TKR.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2013 (estimated)
- Study start9 Jan 2014
- Primary completion5 Nov 2016
- Study completion5 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Elena Losina, Brigham and Women's Hospital
- Investigators
- Elena Losina, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01970631
- Sponsor's protocol ID
- 2013P000916
- Other IDs
- R21AR063913
- Acronym
- SPARKS
- Status last verified
- Jan 2018
- First submitted
- 23 Oct 2013
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28732147Usiskin 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.
PubMed 27585441
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Physical Activity Rewards After Knee Surgery
- ClinicalTrials.gov ID
- NCT01970631
- Acronym / sponsor ID
- SPARKS / 2013P000916
- Conditions
- Osteoarthritis, Degenerative Joint Disease
- Keywords
- Osteoarthritis, Total Knee Replacement, total Knee Arthroplasty, Post-operative recovery TKR, Physical Activity, Motivational Interviewing, Financial Incentives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 9 Jan 2014 (actual)
- Primary completion
- 5 Nov 2016 (actual)
- Study completion
- 5 Nov 2016 (actual)
- First posted
- 28 Oct 2013 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Participants randomized to the Usual Care group will receive the current standard post-operative TKR care. |
| Motivational Interviewing (MI) | Active comparator | Behavioral: 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. |
| Financial Incentives (FI) | Active comparator | Other: Financial IncentivesParticipants 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 comparator | Behavioral: Motivational Interviewing (MI), Other: Financial IncentivesParticipants 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| 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). | Behavioural | Motivational Interviewing (MI), Motivational Inverterviewing (MI) + Financial Incentives (FI) |
| Financial IncentivesThe 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. | Other | Financial Incentives (FI), Motivational Inverterviewing (MI) + Financial Incentives (FI) |
Primary outcome
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.
1 secondary outcome
Adherence to PA guidelines
Time frame: 6-months
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 18 Jan 2018.
- Results publication: PubMed 28732147Losina 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.
- Derived from this study: PubMed 27585441Usiskin 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.
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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.
Elena Losina, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing (MI) and Financial Incentives in people with Osteoarthritis and Degenerative Joint Disease, run by Brigham and Women's Hospital at 1 site 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 5 inclusion and 15 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 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
number of steps (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01970631, which also lists 2 linked publications.
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 18 Jan 2018.