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CompletedNCT03435549Updated Jul 22, 2019

Automated Hovering for Joint Replacement Surgery

An interventional study of Remote monitoring and Remote monitoring plus goal setting and social support in Joint Disease, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-07-22.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

This will evaluate the effectiveness of automated hovering to encourage patients to be discharged to home after hip or knee replacement surgery. Automated hovering includes monitoring of physical activity with an activity monitor, tracking of pain scores, daily feedback and motivational messages, social influence, and connection to clinicians as needed.

Read the detailed description

The goal of this study is to test the approach of automated hovering to encourage patients to be discharged to home safely after lower extremity joint replacement surgery (LEJR). The investigators will target those patients undergoing hip or knee replacement surgery at a large urban hospital system at two different sites. The investigators aim is to increase the number of patients that are discharged to home, by providing patients with a physical activity pedometer, daily pain score tracking through bi-directional text messaging, milestone and nudge messaging for recovery, social influence, and connection to clinicians as needed for 6 weeks after surgery. Eligible participants are age 18-85, with a Risk Assessment and Prediction Tool (RAPT) score of 6-8 and are scheduled to undergo lower-extremity joint replacement surgery. Participants will be randomized 1:1 to usual care (Arm 1) and intervention (Arms 2a and 2b). After enrollment with the monitoring device, participants in the intervention group will be randomized 1:1 to Arm 2a (remote monitoring) or Arm 2b (remote monitoring + goal-setting and social support). Both intervention arms will receive the intervention for 6 weeks post-surgery.

02

Conditions studied

  • Joint Disease

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03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Eligibility Criteria: University of Pennsylvania Health System (UPHS) patients between the ages of 18-85 with a Risk Assessment and Prediction Tool (RAPT) of 6-8 and scheduled to undergo primary lower-extremity joint replacement surgery.

Exclusion criteria

Exclusion Criteria:

  • Patients will be excluded if they do not meet all of the inclusion criteria, or if they have bilateral or revision surgery, dementia, end stage renal disease, cirrhosis, metastatic cancer, non- English speaker, or other physical impairment (ex. amputation)
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
300 participants (actual)

Study arms

  • No intervention
    Arm 1: Control Arm (Usual care)

    If Patient is randomized to Arm 1, no contact will occur, patient will receive standard and routine clinical care

  • Experimental
    Arm 2a: Remote monitoring

    If Patient is randomized to Arm 2a they will remote monitoring for 6 weeks post-surgery

    Behavioral: Remote monitoring

  • Experimental
    Arm 2b: Remote monitoring plus goal setting and social support

    If Patient is randomized to Arm 2b, they will receive a remote monitoring plus social support and nudge messaging for 6 weeks post-surgery

    Behavioral: Remote monitoring plus goal setting and social support

Interventions

  • BehavioralRemote monitoring

    Patients given an activity tracker to wear for 6 weeks after LEJR replacement surgery. For 2 weeks after surgery, they will also receive a daily text messages asking what their pain is on a scale of 0 to 10. They will be asked to reply to the text with their pain score. They will also be sent occasional messaging about their recovery, tips of what to do, and feedback on their progress. They will also also be sent a text message if they stop using their activity tracker for 3 days.

  • BehavioralRemote monitoring plus goal setting and social support

    Patients given activity tracker to wear for 6 weeks after LEJR surgery. For 2 weeks after surgery, they will receive a daily text messages asking what their pain is on a scale of 0 to 10 and asked to reply by text. They will be sent occasional messaging about their recovery, tips of what to do, and feedback on their progress. They will also also be sent a text message if they stop using their activity tracker for 3 days. Patients will be asked to identify a a friend or family member to act as support partner. The study will share progress updates with support partner and contact this individual if patient stops wearing the activity tracker for over 3 days. This partner will also be able to provide supportive messages to help encourage them to reach their activity goals.

05

What researchers measure

Primary outcomes

  1. Discharged to home

    % of patients discharged to home

    Time frame: Day of discharge through study completion at 6 weeks

  2. Step increase

    % of step increase as measured by activity tracker

    Time frame: 6 weeks post discharge

Secondary outcomes

  1. Days spent at home

    Number of days spent at home after discharge

    Time frame: 6 weeks post discharge

  2. Timed Up and Go (TUG) score

    % change in TUG score

    Time frame: 6 weeks post discharge

06

Study locations

1 site
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
07

References and documents

Publications

  • Mehta SJ, Hume E, Troxel AB, Reitz C, Norton L, Lacko H, McDonald C, Freeman J, Marcus N, Volpp KG, Asch DA. Effect of Remote Monitoring on Discharge to Home, Return to Activity, and Rehospitalization After Hip and Knee Arthroplasty: A Randomized Clinical Trial. JAMA Netw Open. 2020 Dec 1;3(12):e2028328. doi: 10.1001/jamanetworkopen.2020.28328. Erratum In: JAMA Netw Open. 2024 Apr 1;7(4):e2412345. doi: 10.1001/jamanetworkopen.2024.12345. PubMed 33346847 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03435549
Lead sponsor
University of Pennsylvania
Responsible party
Sponsor
First posted
Feb 19, 2018
Start date
Feb 7, 2018
Primary completion
Apr 12, 2019
Completion
Apr 12, 2019
Last update
Jul 22, 2019

Study contacts

Shivan Mehta, MD
principal investigator · University of Pennsylvania

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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