TelemedicineTelehealthNCT05654389
Effectiveness of Teleconsultation in Referring a Patient With Early Myocardial Infarction From Peripheral Hospital to Cardiac Centre in Hail, Saudi Arabia
A study testing Application of teleconsultation for a patient with a provisional diagnosis of myocardial infarction at the district hospital in people with Telemedicine, run by The New Model of Care, Hail Health Cluster.
Trial summary
The goal of this pragmatic trial is to test the benefit of using a teleconsultation for referring a patient with a heart attack at an early stage from the suburban hospital to the heart centre. A teleconsultation with an expert cardiologist will be conducted by the physician at a suburban hospital. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Telemedicine
- What is being tested?
- Application of teleconsultation for a patient with a provisional diagnosis of myocardial infarction at the district hospital
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Jul 2023
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patient aged 18 to 80 with provisional diagnose of MI
Who cannot join
- severely ill patient and patient with other chronic conditions or cancer
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of a New Pathway of Referring a Patient With Early Myocardial Infarction From Peripheral Hospital to Cardiac Centre in Hail, Saudi Arabia: A Randomized Clustered Trial
The goal of this pragmatic trial is to test the benefit of using a teleconsultation for referring a patient with a heart attack at an early stage from the suburban hospital to the heart centre. A teleconsultation with an expert cardiologist will be conducted by the physician at a suburban hospital. The main questions it aims to answer are:
To what extent does the use of a teleconsultation for a patient with a heart attack work well in lowering the proportion of deaths among patients with heart attacks who will be referred from suburban hospitals to the heart centre? To what extent does the use of a teleconsultation for a patient with a heart attack work well in raising the proportion of stable cases with heart attacks who will be referred from suburban hospitals to the heart centre? Participants will be asked to participate in a teleconsultation referral pathway from the suburban hospital to the heart centre.
Read more
Researchers will compare the change in the proportion of death rate and survivors or stable cases in the intervention versus the control group during referral from suburban hospital to heart centre.
Making use of telehealth and smart applications will positively improve the quality of the provided health service at suburban hospitals where there is a limited number of specialized doctors.
Read the detailed description
The economic burden of myocardial infarction is the highest in Saudi Arabia. This burden is mainly due to the associated costs of medical interventions and the length of hospital stay.
It is advisable that the health system in Saudi Arabia deploy appropriate measures for the prevention and early detection of myocardial infarction among diabetic patients. Otherwise, the economic burden of cardiovascular diseases is expected to shoot up.
A practical approach for referring patients with Myocardial Infarction (MI) is the modified meta-plan methodology for refereeing a patient from primary care to a cardiology clinic. This approach is recommended as an additional practical pathway for a patient with cardiovascular disease in primary care.
A concentrated value assessment model (CVAM) for determining percutaneous coronary intervention (PCI) levels is suggested to predict MI using accumulated sessions of ECG observation.
Patients at high risk of future myocardial infarction could be identified by every optician at the eye clinic using retinal images and demographic data,
Research Questions:
To what extent does the use of a teleconsultation intervention is effective in reducing the proportion of deaths among patients with myocardial infarction who will be referred from peripheral hospital to the cardiac centre? To what extent does the use of teleconsultation is effective in increasing the proportion of stable cases with myocardial infarction who will be referred from the peripheral hospital to the cardiac centre?
General objective:
To estimate the effectiveness of using a teleconsultation for patients with myocardial infarction at peripheral hospitals in reducing the proportion of deaths and increasing the proportion of stable cases among referral cases.
Specific Objectives:
Aim 1: To compare the proportion of death among cases with myocardial infarction who will be referred from a peripheral hospital to the cardiac centre in the intervention versus the control group (routine care).
Aim 2: To compare the proportion of stable cases of myocardial infarction who will be referred from the peripheral hospital to the cardiac centre in the intervention versus the control group (routine care).
Aim 3: To compare the proportion of cases who developed co-morbidities such as heart failure in the intervention versus the control group (routine care).
Literature Review:
A positive protective effect of antidepressant use to protect against developing myocardial infarction as primary care intervention is evident.
Research Design and Methods:
This is a six months clustered randomized trial that will recruit patients with provisional a diagnosis of myocardial infarction at a governmental peripheral hospital in Hail city.
Participants (P):
The participants will be adults presented to the physician at the peripheral hospital with symptoms and signs of myocardial infarction. The participants are expected to be adults aged 18 years and above. Children and young adults will be excluded. The aim is to report eligible cases by the physician at the peripheral hospital upon satisfaction with the written criteria for early MI diagnosis. The reporting will continue for six months from the beginning of the trial. Cases in both intervention and control clusters will be notified and reported regularly.
- Conditions
- Telemedicine
- Being tested
- Application of teleconsultation for a patient with a provisional diagnosis of myocardial infarction at the district hospital
- Keywords
- telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of teleconsultation for a patient with a provisional diagnosis of myocardial infarction at the district hospitalOther
Using teleconsultation for a patient with a provisional diagnosis of myocardial infarction during referral from the district hospital to the cardiac centre
| Study group | Role | What they receive |
|---|---|---|
| Application of teleconsultation using WhatsApp to refer patient with with myocardial infarction | Experimental | Application of teleconsultation using WhatsApp for a patient with myocardial infarction with a provisional diagnosis of myocardial infarction during referral from a district hospital to a cardiac centre. Receives: Other: Application of teleconsultation for a patient with a provisional diagnosis of myocardial infarction at the district hospital |
| Routine care and handling of a patient with mycardial infarction at peripheral hospital | No intervention | Routine care and consultation received by a patient with a provisional diagnosis of myocardial infarction during referral from the district hospital to the cardiac centre |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of death among patients with myocardial infarction who will be referred from the peripheral hospital to the cardiac centre
The proportion of death among patients with myocardial infarction who will be referred from the peripheral hospital to the cardiac centre in the intervention versus the control group (routine care).
Measured: 6 month from the start of the study
The proportion of stable cases of myocardial infarction who will be referred from the peripheral hospital to the cardiac centre
The proportion of stable cases of myocardial infarction who will be referred from the peripheral hospital to the cardiac centre in the intervention versus the control group (routine care).
Measured: 6 month from the start of the study
Secondary outcomes (2)
The proportion of stable cases of myocardial infarction who received Tissue Plasminogen Activator (TBA) before referral
The proportion of stable cases of myocardial infarction who received Tissue Plasminogen Activator (TBA) before referral from the peripheral hospital to the cardiac centre in the intervention group versus the control group (routine care).
Measured: 6 months after the start of the study
The proportion of stable cases of myocardial infarction who developed co-morbidities
The proportion of stable cases of myocardial infarction who developed co-morbidities such as heart failure in the intervention versus the control group (routine care).
Measured: 6 months after the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study startJan 2023 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelemedicineStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The New Model of Care, Hail Health Cluster
- Sponsor type
- Other government
- Collaborators
- Health Holding Company, Hail Health Cluster, Saudi Arabia
- Responsible party
- Sponsor
- Investigators
- Khalil Alshammari, VIP Chief MO, Study chair, The New Model of Care, Hail Health ClusterFakhralddin Elfakki, Researcher at MOC, Principal investigator, New Model of Care, Hail Health CluserMeshari Aljamani, MOC Lead, Study director, New Model of Care, Hail Health Cluster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654389
- Sponsor's protocol ID
- Model of Care
- Acronym
- Telehealth
- Status last verified
- Dec 2022
- First submitted
- 7 Dec 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a New Pathway of Referring a Patient With Early Myocardial Infarction From Peripheral Hospital to Cardiac Centre in Hail, Saudi Arabia: A Randomized Clustered Trial
- ClinicalTrials.gov ID
- NCT05654389
- Acronym / sponsor ID
- Telehealth / Model of Care
- Conditions
- Telemedicine
- Keywords
- telemedicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- The New Model of Care, Hail Health ClusterOther government
- Collaborators
- Health Holding Company, Hail Health Cluster, Saudi Arabia
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 16 Dec 2022 (actual)
- 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.
The goal of this pragmatic trial is to test the benefit of using a teleconsultation for referring a patient with a heart attack at an early stage from the suburban hospital to the heart centre. A teleconsultation with an expert cardiologist will be conducted by the physician at a suburban hospital. The main questions it aims to answer are:
To what extent does the use of a teleconsultation for a patient with a heart attack work well in lowering the proportion of deaths among patients with heart attacks who will be referred from suburban hospitals to the heart centre? To what extent does the use of a teleconsultation for a patient with a heart attack work well in raising the proportion of stable cases with heart attacks who will be referred from suburban hospitals to the heart centre? Participants will be asked to participate in a teleconsultation referral pathway from the suburban hospital to the heart centre.
Researchers will compare the change in the proportion of death rate and survivors or stable cases in the intervention versus the control group during referral from suburban hospital to heart centre.
Making use of telehealth and smart applications will positively improve the quality of the provided health service at suburban hospitals where there is a limited number of specialized doctors.
Detailed description
The economic burden of myocardial infarction is the highest in Saudi Arabia. This burden is mainly due to the associated costs of medical interventions and the length of hospital stay.
It is advisable that the health system in Saudi Arabia deploy appropriate measures for the prevention and early detection of myocardial infarction among diabetic patients. Otherwise, the economic burden of cardiovascular diseases is expected to shoot up.
A practical approach for referring patients with Myocardial Infarction (MI) is the modified meta-plan methodology for refereeing a patient from primary care to a cardiology clinic. This approach is recommended as an additional practical pathway for a patient with cardiovascular disease in primary care.
A concentrated value assessment model (CVAM) for determining percutaneous coronary intervention (PCI) levels is suggested to predict MI using accumulated sessions of ECG observation.
Patients at high risk of future myocardial infarction could be identified by every optician at the eye clinic using retinal images and demographic data,
Research Questions:
To what extent does the use of a teleconsultation intervention is effective in reducing the proportion of deaths among patients with myocardial infarction who will be referred from peripheral hospital to the cardiac centre? To what extent does the use of teleconsultation is effective in increasing the proportion of stable cases with myocardial infarction who will be referred from the peripheral hospital to the cardiac centre?
General objective:
To estimate the effectiveness of using a teleconsultation for patients with myocardial infarction at peripheral hospitals in reducing the proportion of deaths and increasing the proportion of stable cases among referral cases.
Specific Objectives:
Aim 1: To compare the proportion of death among cases with myocardial infarction who will be referred from a peripheral hospital to the cardiac centre in the intervention versus the control group (routine care).
Aim 2: To compare the proportion of stable cases of myocardial infarction who will be referred from the peripheral hospital to the cardiac centre in the intervention versus the control group (routine care).
Aim 3: To compare the proportion of cases who developed co-morbidities such as heart failure in the intervention versus the control group (routine care).
Literature Review:
A positive protective effect of antidepressant use to protect against developing myocardial infarction as primary care intervention is evident.
Research Design and Methods:
This is a six months clustered randomized trial that will recruit patients with provisional a diagnosis of myocardial infarction at a governmental peripheral hospital in Hail city.
Participants (P):
The participants will be adults presented to the physician at the peripheral hospital with symptoms and signs of myocardial infarction. The participants are expected to be adults aged 18 years and above. Children and young adults will be excluded. The aim is to report eligible cases by the physician at the peripheral hospital upon satisfaction with the written criteria for early MI diagnosis. The reporting will continue for six months from the beginning of the trial. Cases in both intervention and control clusters will be notified and reported regularly.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Application of teleconsultation using WhatsApp to refer patient with with myocardial infarction | Experimental | Other: Application of teleconsultation for a patient with a provisional diagnosis of myocardial infarction at the district hospitalApplication of teleconsultation using WhatsApp for a patient with myocardial infarction with a provisional diagnosis of myocardial infarction during referral from a district hospital to a cardiac centre. |
| Routine care and handling of a patient with mycardial infarction at peripheral hospital | No intervention | –Routine care and consultation received by a patient with a provisional diagnosis of myocardial infarction during referral from the district hospital to the cardiac centre |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patient aged 18 to 80 with provisional diagnose of MI
Key exclusion criteria (1 listed)
- severely ill patient and patient with other chronic conditions or cancer
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 |
|---|---|---|
| Application of teleconsultation for a patient with a provisional diagnosis of myocardial infarction at the district hospitalUsing teleconsultation for a patient with a provisional diagnosis of myocardial infarction during referral from the district hospital to the cardiac centre | Other | Application of teleconsultation using WhatsApp to refer patient with with myocardial infarction |
Primary outcome
The proportion of death among patients with myocardial infarction who will be referred from the peripheral hospital to the cardiac centre
Time frame: 6 month from the start of the study
The proportion of death among patients with myocardial infarction who will be referred from the peripheral hospital to the cardiac centre in the intervention versus the control group (routine care).
The proportion of stable cases of myocardial infarction who will be referred from the peripheral hospital to the cardiac centre
Time frame: 6 month from the start of the study
The proportion of stable cases of myocardial infarction who will be referred from the peripheral hospital to the cardiac centre in the intervention versus the control group (routine care).
2 secondary outcomes
The proportion of stable cases of myocardial infarction who received Tissue Plasminogen Activator (TBA) before referral
Time frame: 6 months after the start of the study
The proportion of stable cases of myocardial infarction who developed co-morbidities
Time frame: 6 months after the start of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Individual participant dataSharing planned: No
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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.
Khalil Alshammari, VIP Chief MO study chair
The New Model of Care, Hail Health Cluster
Fakhralddin Elfakki, Researcher at MOC principal investigator
New Model of Care, Hail Health Cluser
Meshari Aljamani, MOC Lead study director
New Model of Care, Hail Health Cluster
Questions about this trial
What is this clinical trial studying?
A study testing Application of teleconsultation for a patient with a provisional diagnosis of myocardial infarction at the district hospital in people with Telemedicine, run by The New Model of Care, Hail Health Cluster.
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 1 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: status not confirmed, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fakhralddin Elfakki, Researcher at MOC (+966530855161, abbasfakhraddin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of death among patients with myocardial infarction who will be referred from the peripheral hospital to the cardiac centre (time frame: 6 month from the start of the study). The study lists 2 primary outcomes in all. 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 28 Dec 2022.