NCT02193854

Brief Summary

Objective This study is aimed to estimate the distance, time and the cost of travel saved by patients who are seeking tele-dermatology (TD) service though smart mobile phones in the resource poor settings at the rural clinics of Mongolia. Methods A cluster-randomised trial was conducted for six months at the 20 rural health clinics selected from three districts in Mongolia. With a computer-generated sequence, health clinics were randomly allocated either to the intervention group, in which all general practitioners (GPs) received TD consultation through Sana system, or the control group, in which GPs referred patients to the dermatologist at district hospital whenever needed. The primary outcome was to estimate the distance traveled, times spend and the cost of travel required in receiving dermal care for patients in rural Mongolia. Analysis was done to estimate the difference between the aforementioned parameters among intervention and control groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
441

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 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

September 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 18, 2014

Completed
Last Updated

July 18, 2014

Status Verified

July 1, 2014

Enrollment Period

4 months

First QC Date

June 9, 2014

Last Update Submit

July 16, 2014

Conditions

Keywords

TelemedicineMobile phoneRural physiciansMongolia

Outcome Measures

Primary Outcomes (1)

  • Comparison between the number of referrals in the control and intervention groups

    Outcome measures are the number of referrals done in the control and in the intervention groups. We compared the difference in the number of referrals with Sana system and without.

    up to 5 months

Secondary Outcomes (1)

  • Satisfaction by physicians and patients by questionnaire

    up to 5 months

Study Arms (1)

Mobile phone

EXPERIMENTAL

General practitioners (GPs) received TD consultation through Sana system. Mobile phones with Sana system installed were provided to 10 rural GPs from three different districts of Mongolia.

Device: Mobile Phone

Interventions

Investigators used Sana system, that is a mobile phone-based, open source software platform for telemedicine services. The Android-based system supports multimedia, location-based data, and text. In the village health clinic, a healthcare worker will interact with a patient and collects data through a step-by-step clinical questionnaire on a smart mobile phone. As patients' data is uploaded to an open source electronic medical record system (OpenMRS) with a diagnosis-specific information and images. The consultant can access the clinical information about the patient and make appropriate diagnoses and treatment recommendations from the secondary hospital.

Mobile phone

Eligibility Criteria

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

You may qualify if:

  • Patients aged 18-98 years visiting with dermal problem.

You may not qualify if:

  • Patients who do not need dermal care.
  • Patients who are already under treatment for dermal problem.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shabbir Syed Abdul

Taipei, Taipei, 11031, Taiwan

Location

Related Links

Study Officials

  • Yu-Chuan Li, MD., PhD.

    Taipei Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2014

First Posted

July 18, 2014

Study Start

September 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

July 18, 2014

Record last verified: 2014-07

Locations