Automated Hovering for Joint Replacement Surgery

NCT ID: NCT03435549

Last Updated: 2019-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-07

Study Completion Date

2019-04-12

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Joint Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

Group Type NO_INTERVENTION

No interventions assigned to this group

Arm 2a: Remote monitoring

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

Group Type EXPERIMENTAL

Remote monitoring

Intervention Type 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.

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

Group Type EXPERIMENTAL

Remote monitoring plus goal setting and social support

Intervention Type 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.

Interventions

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Remote 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.

Intervention Type BEHAVIORAL

Remote 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shivan Mehta, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33346847 (View on PubMed)

Other Identifiers

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828882

Identifier Type: -

Identifier Source: org_study_id

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