The Effect of an Integrated Mobile Health Platform on Early Detection of Clinical Outcomes of Critical Ill Patients

August 16, 2026 updated by: Asmaa Ayoub Yaseen, Sohag University
This study will aim to examine the Effect of integrated Mobile Health Platform on early detection of clinical outcomes of Critical ill patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study clarify if using if using the electric platform will reduce the complications in critical ill patients this complications include respiratory complications, renal complications, cardiac complications

Study Type

Interventional

Enrollment (Estimated)

250

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 Contact

Study Contact Backup

  • Name: Mogedda Mehany, PhD
  • Phone Number: +201066645420

Study Locations

  • Egypt
    • Sohag Governorate
      • Sohag, Sohag Governorate, Egypt
        • Sohag University Hospital, General Intensive Care Unit

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adult patients aged 18-65 years.
  2. Anticipated ICU stay of more than 24 hours.
  3. Clinical requirement and ability to continuously monitor vital signs and urine output.
  4. Obtained written informed consent from the patient or their legal guardians.

Exclusion Criteria:

  1. Patients placed in strict isolation due to highly infectious diseases.
  2. Death within 24 hours of ICU admission.
  3. Patients transferred from another external Intensive Care Unit.
  4. Re-admission to the ICU during the active study period.
  5. Pre-existing chronic altered consciousness or irreversible neurological deficit.
  6. Patients who underwent pre-hospital cardiopulmonary resuscitation (CPR).

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mHealth Intervention Group
Critically ill patients in the ICU managed using the integrated Mobile Health (mHealth) platform, where real-time patient data and automated early warning scores trigger immediate mobile alerts for clinicians.
Device: Integrated Mobile Health Platform
A digital health platform integrated with ICU monitoring systems to automatically collect, record, and analyze patient vital signs and lab trends, generating real-time early warning alerts for healthcare providers.
No Intervention: Control Group
Critically ill patients in the ICU receiving standard clinical monitoring and conventional early deterioration detection protocols without the use of the mHealth platform.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU Mortality Rate
Time Frame: From ICU admission up to 30 days.
The percentage of critically ill patients who die in the General Intensive Care Unit during their hospital stay. This will evaluate the impact of the mHealth platform on reducing patient mortality.
From ICU admission up to 30 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU Length of Stay (LOS)
Time Frame: From ICU admission up to 30 days.
The total number of days each patient spends in the General Intensive Care Unit from the day of admission until discharge.
From ICU admission up to 30 days.
Incidence of Clinical Complications
Time Frame: Daily from study enrollment until ICU discharge, up to 30 days.
The occurrence of organ-specific complications during the ICU stay, including respiratory (pulmonary edema, ARDS, pneumonia, difficult weaning), cardiac (cardiac arrest, shock, arrhythmia), and renal complications (acute renal failure).
Daily from study enrollment until ICU discharge, up to 30 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

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 (Estimated)

July 28, 2026

Primary Completion (Estimated)

April 28, 2027

Study Completion (Estimated)

May 28, 2027

Study Registration Dates

First Submitted

August 5, 2026

First Submitted That Met QC Criteria

August 16, 2026

First Posted (Actual)

August 19, 2026

Study Record Updates

Last Update Posted (Actual)

August 19, 2026

Last Update Submitted That Met QC Criteria

August 16, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1120261461

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data underlying the final results of this study will be made available to ensure transparency and promote collaborative scientific research.

IPD Sharing Time Frame

Data will become available 6 months after publication of the main study results and will remain accessible for up to 3 years.

IPD Sharing Access Criteria

Data will be shared with qualified researchers upon reasonable formal request directed to the primary investigator for the purpose of secondary scientific analysis.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Subscribe