NCT07773675

Brief Summary

This study will aim to examine the Effect of integrated Mobile Health Platform on early detection of clinical outcomes of Critical ill patients.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress22%
Jul 2026May 2027

Study Start

First participant enrolled

July 28, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 19, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2027

Last Updated

August 19, 2026

Status Verified

August 1, 2026

Enrollment Period

9 months

First QC Date

August 5, 2026

Last Update Submit

August 16, 2026

Conditions

Mobile Health PlatformClinical Outcomes

Keywords

Mobile health platformEarly detection

Outcome Measures

Primary Outcomes (1)

  • ICU Mortality Rate

    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 Outcomes (2)

  • ICU Length of Stay (LOS)

    From ICU admission up to 30 days.

  • Incidence of Clinical Complications

    Daily from study enrollment until ICU discharge, up to 30 days.

Study Arms (2)

mHealth Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Critically ill patients in the ICU receiving standard clinical monitoring and conventional early deterioration detection protocols without the use of the mHealth platform.

Interventions

Integrated Mobile Health PlatformDEVICE

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.

mHealth Intervention Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital, General Intensive Care Unit

Sohag, Sohag Governorate, Egypt

Location

Central Study Contacts

Asmaa Yassen, MSc

CONTACT

+201095196756asmaayaseen487@gmail.com

Mogedda Mehany, PhD

CONTACT

+201066645420

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
This is an open-label study where patients, care providers, and investigators cannot be masked due to the nature of the digital health intervention. However, the biostatistician/data analyst will be blinded to the treatment assignment during data analysis to minimize detection and reporting bias.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study utilizes a prospective, quasi-experimental, non-randomized controlled interventional design to evaluate the efficacy of an integrated Mobile Health (mHealth) platform.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Critical Care and Emergency Nursing

Study Record Dates

First Submitted

August 5, 2026

First Posted

August 19, 2026

Study Start

July 28, 2026

Primary Completion (Estimated)

April 28, 2027

Study Completion (Estimated)

May 28, 2027

Last Updated

August 19, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Data will become available 6 months after publication of the main study results and will remain accessible for up to 3 years.
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.

Locations

EG(1)