NCT03922737

Brief Summary

This study aims to evaluate the quality of care provided by a home-based teleheath program as a safe and acceptable alternative to an in-person office visit as determined by satisfaction with the program and the amount of further medical management required by the patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 6, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 22, 2019

Status Verified

April 1, 2019

Enrollment Period

1.7 years

First QC Date

April 17, 2019

Last Update Submit

April 19, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient Satisfaction: Likert Score

    Likert Score self-reported patient satisfaction

    2 mont post-operative period following surgery

Study Arms (2)

In-person office visit

ACTIVE COMPARATOR
Procedure: In-person office visit

Telehealth visit with provider

ACTIVE COMPARATOR
Procedure: Teleheath visit

Interventions

Post-operative visit to occur in-person with provider

In-person office visit

Post-operative visit to occur via telehealth software platform with provider

Telehealth visit with provider

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Subjects over 18 and under 75 years of age undergoing elective primary orthopaedic surgery at Thomas Jefferson University Hospital, Rothman Orthopaedic Specialty Hospital or Methodist Hospital who have the capability to utilize a telecommunications platform (computer, tablet or similar device at home with a webcam, microphone and access to high-speed internet).

You may not qualify if:

  • Subjects who are unable to access the telemedicine platform or who are uncomfortable with following up in this fashion
  • Subjects who are unable or unwilling to provide post-operative radiographs electronically or who are unable or unwilling to obtain them
  • Subjects with workman's compensation or automotive claims or other ongoing litigation
  • Subjects that are unable or unwilling to consent for enrollment
  • Patients under the age of 18 years
  • Pregnant or breastfeeding women
  • Patients undergoing surgery for tumor, trauma or infection or who require revision or staged procedures
  • Patients without English-language proficiency
  • Patients with unforeseen intra-operative or perioperative complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2019

First Posted

April 22, 2019

Study Start

October 6, 2017

Primary Completion

June 1, 2019

Study Completion

December 1, 2019

Last Updated

April 22, 2019

Record last verified: 2019-04

Locations