Social DistanceNCT02193854
Teledermatology Solution Through Mobile Phone in Rural Mongolia
A study testing Mobile Phone in people with Social Distance, run by Taipei Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Distance
- What is being tested?
- Mobile Phone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 441 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-98 years visiting with dermal problem.
Who cannot join
- Patients who do not need dermal care.
- Patients who are already under treatment for dermal problem.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The 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.
- Conditions
- Social Distance
- Being tested
- Mobile Phone
- Keywords
- Telemedicine, Mobile phone, Rural physicians, Mongolia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile PhoneDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Mobile Phone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 5 months
Secondary outcomes (1)
Satisfaction by physicians and patients by questionnaire
Both physicians and patients who were in the intervention group were satisfied by the Sana system.
Measured: up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startSep 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social DistanceStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 441 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Science University of Mongolia
- Responsible party
- Sponsor
- Investigators
- Yu-Chuan Li, MD., PhD., Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193854
- Sponsor's protocol ID
- TaipeiMU
- Status last verified
- Jul 2014
- First submitted
- 9 Jun 2014
- Last updated
- 18 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teledermatology Solution Through Mobile Phone in Rural Mongolia
- ClinicalTrials.gov ID
- NCT02193854
- Acronym / sponsor ID
- TaipeiMU
- Conditions
- Social Distance
- Keywords
- Telemedicine, Mobile phone, Rural physicians, Mongolia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 441 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- Health Science University of Mongolia
- Study start
- Sep 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 18 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile phone | Experimental | Device: Mobile PhoneGeneral 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18-98 years visiting with dermal problem.
Key exclusion criteria (2 listed)
- Patients who do not need dermal care.
- Patients who are already under treatment for dermal problem.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile PhoneInvestigators 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. | Device | Mobile phone |
Primary outcome
Comparison between the number of referrals in the control and intervention groups
Time frame: up to 5 months
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.
1 secondary outcome
Satisfaction by physicians and patients by questionnaire
Time frame: up to 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2014.
- International Center for Health Information TechnologiesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Chuan Li, MD., PhD. principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Phone in people with Social Distance, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between the number of referrals in the control and intervention groups (time frame: up to 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2014.