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Effectiveness of Teleconsultation in Referring a Patient With Early Myocardial Infarction From Peripheral Hospital to Cardiac Centre in Hail, Saudi Arabia (Telehealth)

Primary Purpose

Telemedicine

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Application of teleconsultation for a patient with a provisional diagnosis of myocardial infarction at the district hospital
Sponsored by
The New Model of Care, Hail Health Cluster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Telemedicine focused on measuring telemedicine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: patient aged 18 to 80 with provisional diagnose of MI Exclusion Criteria: severely ill patient and patient with other chronic conditions or cancer

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Application of teleconsultation using WhatsApp to refer patient with with myocardial infarction

    Routine care and handling of a patient with mycardial infarction at peripheral hospital

    Arm Description

    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.

    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

    Outcomes

    Primary Outcome Measures

    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).
    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).

    Secondary Outcome Measures

    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).
    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).

    Full Information

    First Posted
    December 7, 2022
    Last Updated
    December 27, 2022
    Sponsor
    The New Model of Care, Hail Health Cluster
    Collaborators
    Health Holding Company, Hail Health Cluster, Saudi Arabia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05654389
    Brief Title
    Effectiveness of Teleconsultation in Referring a Patient With Early Myocardial Infarction From Peripheral Hospital to Cardiac Centre in Hail, Saudi Arabia
    Acronym
    Telehealth
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2023 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    July 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The New Model of Care, Hail Health Cluster
    Collaborators
    Health Holding Company, Hail Health Cluster, Saudi Arabia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Telemedicine
    Keywords
    telemedicine

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    440 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Application of teleconsultation using WhatsApp to refer patient with with myocardial infarction
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Routine care and handling of a patient with mycardial infarction at peripheral hospital
    Arm Type
    No Intervention
    Arm Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Application of teleconsultation for a patient with a provisional diagnosis of myocardial infarction at the district hospital
    Intervention Description
    Using teleconsultation for a patient with a provisional diagnosis of myocardial infarction during referral from the district hospital to the cardiac centre
    Primary Outcome Measure Information:
    Title
    The proportion of death among patients with myocardial infarction who will be referred from the peripheral hospital to the cardiac centre
    Description
    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).
    Time Frame
    6 month from the start of the study
    Title
    The proportion of stable cases of myocardial infarction who will be referred from the peripheral hospital to the cardiac centre
    Description
    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).
    Time Frame
    6 month from the start of the study
    Secondary Outcome Measure Information:
    Title
    The proportion of stable cases of myocardial infarction who received Tissue Plasminogen Activator (TBA) before referral
    Description
    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).
    Time Frame
    6 months after the start of the study
    Title
    The proportion of stable cases of myocardial infarction who developed co-morbidities
    Description
    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).
    Time Frame
    6 months after the start of the study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: patient aged 18 to 80 with provisional diagnose of MI Exclusion Criteria: severely ill patient and patient with other chronic conditions or cancer
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fakhralddin Elfakki, Researcher at MOC
    Phone
    +966530855161
    Email
    abbasfakhraddin@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marwa Mahmoud Mahdy, CSoC Lead
    Phone
    +966508258235
    Email
    maroo_79@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Khalil Alshammari, VIP Chief MO
    Organizational Affiliation
    Hail Health Cluster
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Fakhralddin Elfakki, Researcher at MOC
    Organizational Affiliation
    New Model of Care, Hail Health Cluser
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Meshari Aljamani, MOC Lead
    Organizational Affiliation
    New Model of Care, Hail Health Cluster
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Effectiveness of Teleconsultation in Referring a Patient With Early Myocardial Infarction From Peripheral Hospital to Cardiac Centre in Hail, Saudi Arabia

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