Technology Interventions to Improve Outcomes After Knee Replacement
Study Details
Study Description
Brief Summary
The purpose of this study is to examine the effects of two technology interventions on health outcomes (e.g., physical activity, sedentary behavior, physical function, pain) after knee replacement at 2 and 5 months .
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Two 8 week technology interventions will be examined and consist of the use of an app and/or website and regular calls. Assessments to examine outcomes will be completed at baseline, as well as at 2 and 5 months.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: NEAT!2 Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5. |
Behavioral: NEAT!2
8 week sedentary reduction program
|
| Active Comparator: MyKneeGuide Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5. |
Behavioral: MyKneeGuide
8 week surgery recovery education program
|
Outcome Measures
Primary Outcome Measures
- Change in Objectively Measured (Actigraph) Sedentary Behavior at 2 months [2 months - baseline]
change sedentary behavior (<100 counts/minute) measured with Actigraph accelerometers between baseline and 3 months
- Change in Objectively Measured (Actigraph) Sedentary Behavior at 5 months [5 months - baseline]
change in sedentary behavior (<100 counts/minute) measured with Actigraph accelerometers between baseline and 6 months
Secondary Outcome Measures
- Change in Physical Function [5 months after surgery]
Six minute walk test
- Change in WOMAC Pain Subscale [5 months after surgery]
WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain)
- Total physical activity measured by Actigraph accelerometers [5 months after surgery]
objectively measured light, moderate and vigorous activity (>= 100 counts/min) by Actigraph accelerometers
- Adherence to NEAT!2 calls [2 months]
Number of calls completed
- Adherence to NEAT!2 app [2 months]
total days NEAT! app was used
- Response to NEAT!2 prompts [2 months]
percentage of notifications in which a transition from sitting to standing was detected
- Change in physical function via chair stand test [5 months after surgery]
Chair stand test
Other Outcome Measures
- Change in physical function via timed up and go [5 months after surgery]
Timed up and go test
- Change in Knee Symptoms - KOOS pain [5 months]
KOOS pain subcale (0 indicates extreme problems, 100 no problems)
- Change in Knee Symptoms - KOOS symptoms [2 months]
KOOS symptoms subcale (0 indicates extreme problems, 100 no problems)
- Change in Knee Symptoms - KOOS ADL [5 months]
KOOS ADL subcale (0 indicates extreme problems, 100 no problems)
- Change in Knee Symptoms - KOOS sport/rec [5 months]
KOOS sport/rec subcale (0 indicates extreme problems, 100 no problems)
- Change in Knee Symptoms - KOOS QoL [5 months]
KOOS QOL subcales (0 indicates extreme problems, 100 no problems)
- Change in knee symptoms via WOMAC [5 months]
WOMAC total score (pain, stiffness, and function) - Scores range from 0 (no problems) to 96 (extreme problems)
- Change in sedentary time via activPAL accelerometers [5 months]
activPAL accelerometer
- Patient Reported outcomes - Mobility - T-Score [5 months]
Patient-Reported Outcomes Measurement Information System (PROMIS) - T score of 50 represents average for general population (scores higher than 50 represent better function and mobility)
- Patient Reported outcomes - global health - T-Score [5 months]
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health - T score of 50 represents average for general population (scores higher than 50 represent better health)
- Patient Reported outcomes - sleep disturbance - T-Score [5 months]
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep disturbance - T score of 50 represents average for general population (scores higher than 50 represent worse sleep disturbance)
- Change in habit strength [5 months]
adapted self-report habit index
- Change in sedentary time via SIT-Q [5 months]
SIT-Q
- Weight [5 months]
Change in weight
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Be 40-79 years of age
-
Had unilateral knee replacement within last 12 months
-
Have an Android or iOS smartphone that is accessible and near them the majority of the day
-
Be willing to download the study applications on their smartphone
-
Spend at least 7 hours/day sitting
-
Be English speaking
Exclusion Criteria:
-
Have any contraindications to activity
-
Have a mobility limiting comorbidity
-
Have a scheduled surgery within the next 6 months
-
Do not have ≥4 days of valid accelerometer (>=10 hours) wear at baseline.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of South Carolina | Columbia | South Carolina | United States | 29208 |
Sponsors and Collaborators
- University of South Carolina
- Northwestern University
- Prisma Health-Midlands
Investigators
- Principal Investigator: Christine Pellegrini, PhD, University of South Carolina
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00092132