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Completed

NCT Number: NCT03435549

Automated Hovering for Joint Replacement Surgery

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.

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Key information

Conditions

Joint Disease Joint Diseases Musculoskeletal Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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)

Treatment and study plan

Remote Monitoring

Behavioral

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.

Remote monitoring plus goal setting and social support

Behavioral

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.

Primary outcomes

  1. Discharged to home

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

    % of patients discharged to home

  2. Step increase

    Time frame: 6 weeks post discharge

    % of step increase as measured by activity tracker

Secondary outcomes

  1. Days spent at home

    Time frame: 6 weeks post discharge

    Number of days spent at home after discharge

  2. Timed Up and Go (TUG) score

    Time frame: 6 weeks post discharge

    % change in TUG score

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 19, 2018
Registry last updated
Jul 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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