Mobile Health PlatformNCT07773675
The Effect of an Integrated Mobile Health Platform on Early Detection of Clinical Outcomes of Critical Ill Patients
A study testing Integrated Mobile Health Platform in people with Mobile Health Platform and Clinical Outcomes, run by Sohag University at 1 site in Egypt.
Trial summary
This study will aim to examine the Effect of integrated Mobile Health Platform on early detection of clinical outcomes of Critical ill patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mobile Health Platform, Clinical Outcomes
- What is being tested?
- Integrated Mobile Health Platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteEgypt
- Study dates
- 12 May 2026to 13 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mogedda Mehany, PhD contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital, General Intensive Care Unit
Sohag, Sohag Governorate
About this study
This study will aim to examine the Effect of integrated Mobile Health Platform on early detection of clinical outcomes of Critical ill patients.
Read the 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
- Conditions
- Mobile Health Platform, Clinical Outcomes
- Being tested
- Integrated Mobile Health Platform
- Keywords
- Mobile health platform, Early detection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From ICU admission up to 30 days.
Secondary outcomes (2)
ICU Length of Stay (LOS)
The total number of days each patient spends in the General Intensive Care Unit from the day of admission until discharge.
Measured: From ICU admission up to 30 days.
Incidence of Clinical Complications
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).
Measured: Daily from study enrollment until ICU discharge, up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start12 May 2026
- Primary completion13 Dec 2026 (estimated)
- Study completion13 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mobile Health PlatformStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study utilizes a prospective, quasi-experimental, non-randomized controlled interventional design to evaluate the efficacy of an integrated Mobile Health (mHealth) platform.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Ayoub Yaseen, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773675
- Sponsor's protocol ID
- 1120261461
- Status last verified
- Oct 2026
- First submitted
- 5 Aug 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the final results of this study will be made available to ensure transparency and promote collaborative scientific research.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Integrated Mobile Health Platform on Early Detection of Clinical Outcomes of Critical Ill Patients
- ClinicalTrials.gov ID
- NCT07773675
- Acronym / sponsor ID
- 1120261461
- Conditions
- Mobile Health Platform, Clinical Outcomes
- Keywords
- Mobile health platform, Early detection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 12 May 2026 (actual)
- Primary completion
- 13 Dec 2026 (estimated)
- Study completion
- 13 May 2027 (estimated)
- First posted
- 19 Aug 2026 (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.
This study will aim to examine the Effect of integrated Mobile Health Platform on early detection of clinical outcomes of Critical ill patients.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study utilizes a prospective, quasi-experimental, non-randomized controlled interventional design to evaluate the efficacy of an integrated Mobile Health (mHealth) platform.
| Arm | Type | Receives |
|---|---|---|
| mHealth Intervention Group | Experimental | Device: Integrated Mobile Health PlatformCritically 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Integrated Mobile Health PlatformA 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. | Device | mHealth Intervention Group |
Primary outcome
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.
2 secondary outcomes
ICU Length of Stay (LOS)
Time frame: From ICU admission up to 30 days.
Incidence of Clinical Complications
Time frame: Daily from study enrollment until ICU discharge, up to 30 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the final results of this study will be made available to ensure transparency and promote collaborative scientific research.
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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.
Mogedda Mehany, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Mobile Health Platform in people with Mobile Health Platform and Clinical Outcomes, run by Sohag University at 1 site in Egypt.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asmaa Yassen, MSc (+201095196756, asmaayaseen487@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU Mortality Rate (time frame: From ICU admission up to 30 days.). 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 26 Oct 2026.