ClinicalTrials.gg
Not yet recruitingNCT07841665Updated Oct 21, 2026

AI-Based Personalized Self-Management for Patients With Heart Failure

An interventional study of Experimental: AI-Based Personalized Self-Management Intervention and Behavioral: AI-Based Personalized Self-Management Intervention in Heart Failure, sponsored by Alexandria University. Not yet recruiting at 2 sites in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Alexandria University · Not applicable, Interventional, and Supportive care

Updated Sep 25, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 63 studies in Heart Failure with a site in Egypt — 16 open to participants now, 21 under way, 2 of them phase 3. Heart Failure · Egypt.

Planned enrollment
7th of 46
150 · median 68
Started
2026
with 10 others
No phase
21 of 63
7 open now
Primary completion
2026-12
later than 13 of 20 live
Registered
62nd of 63
by date
Lead sponsor
6 of 63
Alexandria University

Among the 63 studies in Heart Failure with a site in Egypt, this one is the 7th largest by planned enrollment of the 46 interventional ones that give a count, is one of 11 that started in 2026, is one of 21 with no phase, reaches primary completion later than 13 of the 20 other live ones, and was the 62nd registered.

Heart Failure

6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.

Browse Heart Failure studies →

Open to participants now

16 of the 63 studies in Heart Failure with a site in Egypt are open now. Recruiting first, the newest first:

10 more — sign in →

All 16 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 968 Heart Failure studies recruiting now, 691 (71%) set no upper age limit and 89 (9%) stop at 75 or younger; 64 take children under 18; 96 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 63 studies in Heart Failure with a site in Egypt, or all of them as a file.
02

Study summary

This study aims to evaluate the effectiveness of an AI-based personalized self-management intervention on self-care behaviors and health-related quality of life among patients with chronic heart failure. Using a two-phase sequential explanatory mixed-methods design, Phase I consists of a randomized controlled trial comparing a 12-week AI-guided self-management intervention plus usual care with usual care alone. Self-care behaviors and health-related quality of life will be assessed at baseline, 6 weeks, and 12 weeks. Phase II will involve semi-structured interviews with a purposively selected subgroup of intervention participants to explore their experiences with the AI-based intervention and to explain the quantitative findings. The study seeks to generate evidence on the effectiveness and patient acceptability of AI-supported self-management in heart failure care.

03

Conditions studied

  • Heart Failure

Browse trials for

Keywords

  • Artificial Intelligence
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Eligibility Criteria

Inclusion criteria

Inclusion Criteria:

Adults aged 18 years or older. Confirmed diagnosis of chronic heart failure ( Class II or III). Clinically stable for at least 1 month before enrollment. Able to read and understand Arabic. Own or have regular access to a smartphone compatible with the AI-based application.

Willing and able to provide and participate throughout the 12-week study period.

Exclusion criteria

Exclusion Criteria:

Class IV or end-stage heart failure. Severe cognitive impairment or any condition preventing reliable self-reporting or .

Severe psychiatric illness that may interfere with study participation. Participation in another heart failure self-management or behavioral intervention program during the study period.

Inability to use a smartphone or the study application despite orientation and support.

Any serious medical condition deemed by the investigators to make participation inappropriate or unsafe.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Experimental: AI-Based Personalized Self-Management Intervention

    Device: Experimental: AI-Based Personalized Self-Management Intervention

  • Active comparator
    Active Comparator: Usual Care

    Behavioral: Behavioral: AI-Based Personalized Self-Management Intervention

Interventions

  • DeviceExperimental: AI-Based Personalized Self-Management Intervention

    Participants receive a smartphone-based AI application delivering personalized self-management support for 12 weeks, including symptom monitoring, individualized self-care recommendations, medication and lifestyle reminders, educational content, and real-time guidance alongside usual care.

  • BehavioralBehavioral: AI-Based Personalized Self-Management Intervention

    Participants receive routine heart failure care, including standard education, outpatient follow-up, and prescribed treatment, without access to the AI-based application.

06

What researchers measure

Primary outcomes

  1. Primary Outcome Measure 1: Self-Care Behavior (EHFScBS-9)

    Description: Change in self-care behavior measured using the 9-item European Heart Failure Self-Care Behaviour Scale (EHFScBS-9). Scores are transformed to a 0-100 scale, with higher scores indicating better self-care behavior.

    Time frame: Time Frame: Baseline, Week 6, and Week 12

  2. Primary Outcome Measure 2: Health-Related Quality of Life (RAND-36)

    Description: Change in health-related quality of life measured using the RAND 36-Item Health Survey (RAND-36). Scores are transformed to a 0-100 scale, with higher scores indicating better health-related quality of life.

    Time frame: Time Frame: Baseline, Week 6, and Week 12

Secondary outcomes

  1. Secondary Outcome Measure 1: Technology Acceptance of the AI-Based Intervention

    Description: Technology acceptance measured using an adapted AI Technology Acceptance Questionnaire based on the Modified Technology Acceptance Model (mTAM). The instrument consists of 16 items assessing Perceived Usefulness, Perceived Ease of Use, Behavioral Intention, and User Satisfaction. Items are rated on a 7-point Likert scale, with higher scores indicating greater acceptance of the AI-based intervention.

    Time frame: Time Frame: Week 12

  2. Secondary Outcome Measure 2: Participants' Experiences With the AI-Based Intervention

    Description: Participants' experiences, perceived benefits, barriers, facilitators, and recommendations regarding the AI-based personalized self-management intervention, assessed through semi-structured interviews and analyzed using thematic analysis.

    Time frame: Time Frame: after completion of the 12-week intervention.

07

Study locations

2 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Dec 2026, 2 months later.

Of 1,118 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 2 months is below that.

Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 20, 2026
First posted
Sep 25, 2026
StartEst.
Oct 2026
Primary completionEst.
Dec 2026
CompletionEst.
Jan 2027
Last update
Oct 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07841665
Responsible party
Mohamed Fakhry Ahmed Salem (Dr, Alexandria University) — Principal investigator
First posted
Sep 25, 2026
Start date
Oct 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Jan 2027 (estimated)
Last update
Oct 21, 2026

Study contacts

Mohamed Fakhry Salem, PhD
Contact
Mohamed.Fakhry@alexu.edu.eg
01286038014
Mohamed Fakhry Salem, PHD
principal investigator · Alexandria University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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