NCT03435549

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 7, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2019

Completed
Last Updated

July 22, 2019

Status Verified

July 1, 2019

Enrollment Period

1.2 years

First QC Date

February 9, 2018

Last Update Submit

July 18, 2019

Conditions

Joint Disease

Outcome Measures

Primary Outcomes (2)

  • Discharged to home

    % of patients discharged to home

    Day of discharge through study completion at 6 weeks

  • Step increase

    % of step increase as measured by activity tracker

    6 weeks post discharge

Secondary Outcomes (2)

  • Days spent at home

    6 weeks post discharge

  • Timed Up and Go (TUG) score

    6 weeks post discharge

Study Arms (3)

Arm 1: Control Arm (Usual care)

NO INTERVENTION

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

Arm 2a: Remote monitoring

EXPERIMENTAL

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

Behavioral: Remote monitoring

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

EXPERIMENTAL

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

Remote monitoringBEHAVIORAL

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 2a: Remote monitoring
Remote monitoring plus goal setting and social supportBEHAVIORAL

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.

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

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

    PMID: 33346847DERIVED

MeSH Terms

Conditions

Joint Diseases

Interventions

Remote Patient Monitoring

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

TelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Shivan Mehta, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2018

First Posted

February 19, 2018

Study Start

February 7, 2018

Primary Completion

April 12, 2019

Study Completion

April 12, 2019

Last Updated

July 22, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)