NCT01821014

Brief Summary

Much of the basic general medical care and chronic disease management in rural Honduras comes from groups of volunteers setting up temporary clinics run by volunteers. These clinics, also known as brigades, or medical missions, are often criticized for their lack of quality and the lack of follow-up, both of which stem, in part, from understaffing with volunteer physicians. This study is designed to assess if it is feasible, safe, and acceptable to treat patients in short-term mobile medical clinics in rural Honduras using US physicians connected with patients by videoconference.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 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

February 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 29, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

May 12, 2014

Status Verified

May 1, 2014

Enrollment Period

4 months

First QC Date

March 20, 2013

Last Update Submit

May 8, 2014

Conditions

Keywords

Diagnostic concordanceTreatment concordancepatient satisfactionphysician satisfactionMedical Outreach ClinicsMedical BrigadesMedical MissionsTelemedicineVideoconferencediagnosestreatmentsSatellite InternetVSATcross cultural telemedicine

Outcome Measures

Primary Outcomes (2)

  • Clinical Diagnoses

    The diagnoses resulting from the two physician visits will be compared and a cohen's kappa statistic will be calculated for diagnoses between the visits.

    Same Day as clinic visit (less than 6 hours)

  • Recommended clinical treatments

    After each of a patient's two physician visits, the physician's resulting recommended treatments will be gathered for comparison between the two visits.

    Same Day as clinic visit (less than 6 hours)

Secondary Outcomes (3)

  • Patient opinions of physician interactions

    Immediately following physician interactions (less than 6 hours)

  • Physician opinions of patient interactions

    immediately following volunteer activities with the clinic (less than 48 hours)

  • Volunteer opinions of physician-patient interactions

    immediately following experience with the clinic (Less than 48 hours)

Other Outcomes (1)

  • Cost

    One year (from pilot to completion of study)

Study Arms (3)

Telemedicine First

EXPERIMENTAL

Patients whose first physician visit during the clinic was using videoconference, a form of telemedicine, and whose second physician visit during the clinic was with a physician in-person.

Other: TelemedicineOther: In-person physician interaction

Telemedicine Second

EXPERIMENTAL

Patients whose first physician visit during the clinic was with a physician in-person, and whose second physician visit during the clinic was using videoconference, a form of telemedicine. This is the reverse order of visits of the "Telemedicine fist" arm.

Other: TelemedicineOther: In-person physician interaction

Two physician visits

ACTIVE COMPARATOR

Patients who had two sequential visits with different in-person physicians.

Other: In-person physician interaction

Interventions

Patients undergo a detailed history and examination to the degree that is possible using the videoconference program, skype, a digital camera for high-resolution images, and an electronic stethoscope. A clinic volunteer aids with examination, translation and documentation.

Also known as: Videoconference, Skype
Telemedicine FirstTelemedicine Second

Patients undergo a detailed history and examination by an in-person physician. A clinic volunteer aids with examination, translation and documentation, as needed.

Also known as: in-person visit, in-person examination, in-person consultation
Telemedicine FirstTelemedicine SecondTwo physician visits

Eligibility Criteria

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

You may qualify if:

  • Able to give informed consent
  • Non-emergent medical complaints
  • At least 18 yrs in age

You may not qualify if:

  • Pregnancy
  • Mental Disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Global Brigades

Tegucigalpa, Francisco Morazán Department, Honduras

Location

MeSH Terms

Conditions

DiseasePatient Satisfaction

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Bart Demaerschalk, MD/MSc

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

March 20, 2013

First Posted

March 29, 2013

Study Start

February 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

May 12, 2014

Record last verified: 2014-05

Locations