- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01821014
Satellite-supplementation of Medical Outreach Clinics: a Feasibility Study
May 8, 2014 updated by: Bart M. Demaerschalk, Mayo Clinic
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
144
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Francisco Morazan
-
Tegucigalpa, Francisco Morazan, Honduras
- Global Brigades
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Able to give informed consent
- Non-emergent medical complaints
- At least 18 yrs in age
Exclusion Criteria:
- Pregnancy
- Mental Disability
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Telemedicine First
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.
|
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.
Other Names:
Patients undergo a detailed history and examination by an in-person physician.
A clinic volunteer aids with examination, translation and documentation, as needed.
Other Names:
|
Experimental: Telemedicine Second
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.
|
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.
Other Names:
Patients undergo a detailed history and examination by an in-person physician.
A clinic volunteer aids with examination, translation and documentation, as needed.
Other Names:
|
Active Comparator: Two physician visits
Patients who had two sequential visits with different in-person physicians.
|
Patients undergo a detailed history and examination by an in-person physician.
A clinic volunteer aids with examination, translation and documentation, as needed.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Diagnoses
Time Frame: Same Day as clinic visit (less than 6 hours)
|
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
Time Frame: Same Day as clinic visit (less than 6 hours)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient opinions of physician interactions
Time Frame: Immediately following physician interactions (less than 6 hours)
|
Patients will receive a survey following each interaction with a doctor.
These surveys cover communication, comfort and satisfaction.
|
Immediately following physician interactions (less than 6 hours)
|
Physician opinions of patient interactions
Time Frame: immediately following volunteer activities with the clinic (less than 48 hours)
|
doctors will fill out a survey about their patient interactions after they complete their experience volunteering with the clinic.
|
immediately following volunteer activities with the clinic (less than 48 hours)
|
Volunteer opinions of physician-patient interactions
Time Frame: immediately following experience with the clinic (Less than 48 hours)
|
Volunteers who helped with physician interactions will receive a survey about their experience concerning physician patient communication, volunteer educational value and perceived value of the experience.
|
immediately following experience with the clinic (Less than 48 hours)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost
Time Frame: One year (from pilot to completion of study)
|
The costs of materials and services required to conduct the patient examinations will be collected to build an economic model and projected cost of scaling up the videoconference interventions.
|
One year (from pilot to completion of study)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bart Demaerschalk, MD/MSc, Mayo Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
March 20, 2013
First Submitted That Met QC Criteria
March 26, 2013
First Posted (Estimate)
March 29, 2013
Study Record Updates
Last Update Posted (Estimate)
May 12, 2014
Last Update Submitted That Met QC Criteria
May 8, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-000132
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Telemedicine
-
Michigan State UniversityUniversity of Michigan; Wake Forest University Health Sciences; Babes-Bolyai...CompletedUsual Care | Telemedicine: Smoking Cessation App Only | Telemedicine: Smoking Cessation Counseling | Telemedicine: App + CounselingRomania
-
The Hong Kong Polytechnic UniversityCompleted
-
Wake Forest University Health SciencesCompleted
-
Buzzi Children's HospitalCompleted
-
The Hong Kong Polytechnic UniversityCompleted
-
University of MichiganCompleted
-
US Department of Veterans AffairsCompleted
-
University Hospital, Basel, SwitzerlandInnosuisse - Swiss Innovation AgencyRecruiting
-
Attune Health Research, Inc.Rheumatology Research FoundationRecruiting
Clinical Trials on Telemedicine
-
NHS Greater Glasgow and ClydeUniversity of Strathclyde; Microsoft CorporationNot yet recruiting
-
University of RochesterAgency for Healthcare Research and Quality (AHRQ)CompletedTelemedicine | Physical DisordersUnited States
-
NHS Greater Glasgow and ClydeJean Brown Bequest Fund, Glasgow, UKNot yet recruitingTelemedicine | Surgery, PlasticUnited Kingdom
-
NHS Greater Glasgow and ClydeUniversity of Strathclyde; Microsoft CorporationCompletedTelemedicine | Reconstructive Surgery | 3 DimensionalUnited Kingdom
-
NHS Greater Glasgow and ClydeUniversity of Strathclyde; Glasgow Royal InfirmaryNot yet recruiting
-
University of MichiganCompleted
-
SciensanoEuropean CommissionRecruitingCancerHungary, Greece, Belgium, Cyprus, Ireland, Italy, Lithuania, Portugal, Slovenia, Spain
-
University of Cape TownKarolinska Institutet; University of California, San Francisco; Grand Challenges...Recruiting
-
University Hospital MuensterPalliativnetz Muenster gGmbH; CompuGroup MedicalCompletedCancer | Chronic Obstructive Pulmonary Disease | Chronic Heart Failure | Palliative CareGermany
-
Aalborg UniversityCompleted