NCT01991782

Brief Summary

The purpose of this study is to determine whether telemedicine video calls for follow-up visits between patients and their orthopaedic trauma surgeons has an impact on patient satisfaction, quality of life, and treatment adherence. This study will also assess the feasibility of telemedicine as a medium for follow-up visits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

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

June 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 11, 2012

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

Enrollment Period

2 years

First QC Date

July 11, 2012

Last Update Submit

December 26, 2014

Conditions

TelemedicineFracture

Keywords

TelemedicineFractureOrthopaedics

Outcome Measures

Primary Outcomes (1)

  • Patient Satisfaction and Clinical Outcomes at Conclusion

    Surveys will be administered to all patients in both arms of the study at the conclusion of the study to assess patient satisfaction with their treatment arms. Furthermore, all clinical outcomes for patients with be addressed at this point to note fracture healing status, any development of complications, and any redefinition of goals of care.

    6 month

Study Arms (2)

Control

NO INTERVENTION

Control patients with all follow-up visits in person at the Vanderbilt Orthopaedic Trauma clinic (2 weeks, 6 weeks, 3 months, and 6 months post-operative).

Telemedicine

EXPERIMENTAL

Experimental cohort with two follow-up visits (6 weeks and 6 months) occurring via telemedicine video calls and two follow-up visits (2 weeks and 3 months) occurring in person.

Other: Telemedicine

Interventions

TelemedicineOTHER

Patients in the telemedicine cohort will have two follow-up visits (at 6 weeks and 6 months) through video calls.

Telemedicine

Eligibility Criteria

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

You may qualify if:

  • adults over 18 years old with closed fracture and having access to telemedicine technology (i.e. high speed Internet) at home

You may not qualify if:

  • patients as part of vulnerable populations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Fractures, Bone

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Manish K Sethi, MD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Orthopaedics

Study Record Dates

First Submitted

July 11, 2012

First Posted

November 25, 2013

Study Start

June 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

December 30, 2014

Record last verified: 2014-12

Locations

US(1)