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Activity Tracker + Motivational Coaching for Knee Replacement Recovery (KArAT Trial)

N/A
Recruiting
Led By Elena Losina, Ph.D.
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 40-85 years
OA is principal underlying indication for TKR
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks pre-tkr to 24 months post-tkr
Awards & highlights

KArAT Trial Summary

This trial is investigating whether TAC(MI)+FI or a physical activity tracker intervention can increase post-TKR PA and QoL, and whether TAC(MI)+FI is more effective than the physical activity tracker intervention.

Who is the study for?
This trial is for English-speaking adults aged 40-85 with osteoarthritis, scheduled for knee replacement surgery at one of the recruitment centers. Participants must be able to wear an activity tracker for most of the week and have access to a device for syncing this data. Exclusions include dementia, certain inflammatory diseases, wheelchair users, upcoming musculoskeletal surgeries within six months after TKR, or any psychological issues affecting participation.Check my eligibility
What is being tested?
The Knee Arthroplasty Activity Trial tests if post-knee replacement patients can increase physical activity using three methods: basic study activities (surveys and clinic visits), wearing a wrist-based activity tracker, or receiving telephonic coaching plus financial rewards for meeting activity goals alongside the tracker use.See study design
What are the potential side effects?
Since this trial involves non-invasive interventions like wearing an activity tracker and receiving phone calls or incentives rather than medical treatments or drugs, there are no direct side effects associated with these activities.

KArAT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 40 and 85 years old.
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My main reason for needing a knee replacement is osteoarthritis.
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I am scheduled for a knee replacement at one of the specified centers.
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My main reason for knee replacement is osteoarthritis.
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I have a device like a computer or smartphone to sync a wrist activity tracker.
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I am between 40 and 85 years old.
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I meet the daily step goal set during the trial's initial phase.
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I have a device like a computer or smartphone to sync a wrist-worn activity tracker.

KArAT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks pre-tkr to 24 months post-tkr
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks pre-tkr to 24 months post-tkr for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Subjects Engaged in at least 150 min/week of moderate-to-vigorous physical activity (MVPA).
Secondary outcome measures
Change in average daily sedentary time
Change in average daily step count
Change in weekly minutes of moderate-to-vigorous activity (MVPA)
Other outcome measures
Change in cost
Change in pain and functional status
Change in performance measures
+2 more

KArAT Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm3Experimental Treatment3 Interventions
Participants in this arm receive usual post-operative care, complete all basic study activities (as described in arm 1), receive wrist-based activity tracker intervention, and receive the TAC(MI)+FI.
Group II: Arm2Experimental Treatment2 Interventions
Participants in this arm receive usual post-operative care, complete all basic study activities (as described in arm 1) and receive the wrist-based activity tracker intervention.
Group III: Arm1Experimental Treatment1 Intervention
Participants in this arm receive usual post-operative care and complete all basic study activities, which include: attending 2 in-clinic visits at designated time-points, having regular check-in calls with study staff over the intervention period, wearing and returning waist-worn activity trackers at 5 time points over two years, and completing 6 study surveys.

Find a Location

Who is running the clinical trial?

University at BuffaloOTHER
131 Previous Clinical Trials
98,359 Total Patients Enrolled
University of Kansas Medical CenterOTHER
459 Previous Clinical Trials
168,504 Total Patients Enrolled
5 Trials studying Osteoarthritis
225 Patients Enrolled for Osteoarthritis
Northwestern Memorial HospitalOTHER
40 Previous Clinical Trials
16,116 Total Patients Enrolled

Media Library

Wrist based activity tracker wear Clinical Trial Eligibility Overview. Trial Name: NCT04107649 — N/A
Osteoarthritis Research Study Groups: Arm2, Arm1, Arm3
Osteoarthritis Clinical Trial 2023: Wrist based activity tracker wear Highlights & Side Effects. Trial Name: NCT04107649 — N/A
Wrist based activity tracker wear 2023 Treatment Timeline for Medical Study. Trial Name: NCT04107649 — N/A
Osteoarthritis Patient Testimony for trial: Trial Name: NCT04107649 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what geographical areas is this medical experiment being conducted?

"Currently, 6 different clinical sites are welcoming patients into this medical trial. These locations include Chicago, Buffalo and Columbia among a few others. To minimize travel commitments for those interested in the study, it's advised to select the centre that is nearest you."

Answered by AI

Are participants of advanced age eligible to partake in this study?

"The eligibility for this trial necessitates that participants are 45-80 years old. 38 trials exist to help those under 18, while 675 studies support elderly individuals over 65."

Answered by AI

Are individuals currently eligible to join this trial?

"According to the data accessible on clinicaltrials.gov, this particular medical trial is not presently recruiting patients since it was last updated on July 19th 2021. Nevertheless, there are 711 other research projects that are currently taking in participants for their studies."

Answered by AI

Is enrollment for this trial still open?

"In order to be included in this research trial, applicants must have arthrosis and should fall between the ages of 45-80. Altogether 600 people are sought for recruitment."

Answered by AI

Who else is applying?

What state do they live in?
Rhode Island
Massachusetts
How old are they?
18 - 65
What site did they apply to?
University of South Carolina - Palmetto Health
Brigham and Women's Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Physical therapy was helpful for one knee and I want to be as active as possible. The other knee started hurting after some kind of movement and it has taken weeks to get better and still causes pain off and on. Curious if more activity can help me.
PatientReceived 1 prior treatment
~400 spots leftby Jun 2028