Heart FailureNCT07841665
AI-Based Personalized Self-Management for Patients With Heart Failure
A study testing Experimental: AI-Based Personalized Self-Management Intervention and Behavioral: AI-Based Personalized Self-Management Intervention in people with Heart Failure, run by Alexandria University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Experimental: AI-Based Personalized Self-Management Intervention and Behavioral: AI-Based Personalized Self-Management Intervention
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesEgypt
- Study dates
- Oct 2026to Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older. Confirmed diagnosis of chronic heart failure (NYHA 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 informed consent and participate throughout the 12-week study period.
Who cannot join
- NYHA Class IV or end-stage heart failure. Severe cognitive impairment or any condition preventing reliable self-reporting or informed consent.
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Salem contact
Egypt2 sites
Faculty of Nursing, Alexandria University
Alexandria, 21511
Mohamed Fakhry Salem, PhD, 01286038014, Mohamed.Fakhry@alexu.edu.eg
Faculty of Nursing, Alexandria University
Alexandria, 21511
About this study
Official title: Effectiveness of AI-Based Personalized Self-Management Intervention on Self-Care Behaviors and Health-Related Quality of Life Among Patients With Heart Failure
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.
- Conditions
- Heart Failure
- Being tested
- Experimental: AI-Based Personalized Self-Management Intervention, Behavioral: AI-Based Personalized Self-Management Intervention
- Keywords
- Artificial Intelligence
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: AI-Based Personalized Self-Management InterventionDevice
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.
Behavioral: AI-Based Personalized Self-Management InterventionBehavioural
Participants receive routine heart failure care, including standard education, outpatient follow-up, and prescribed treatment, without access to the AI-based application.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: AI-Based Personalized Self-Management Intervention | Experimental | Not described Receives: Device: Experimental: AI-Based Personalized Self-Management Intervention |
| Active Comparator: Usual Care | Active comparator | Not described Receives: Behavioral: Behavioral: AI-Based Personalized Self-Management Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time Frame: Baseline, Week 6, and Week 12
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.
Measured: Time Frame: Baseline, Week 6, and Week 12
Secondary outcomes (2)
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.
Measured: Time Frame: Week 12
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.
Measured: Time Frame: after completion of the 12-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fakhry Ahmed Salem, Alexandria University
- Investigators
- Mohamed Fakhry Salem, PHD, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841665
- Sponsor's protocol ID
- AIHF-2026-01
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of AI-Based Personalized Self-Management Intervention on Self-Care Behaviors and Health-Related Quality of Life Among Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT07841665
- Acronym / sponsor ID
- AIHF-2026-01
- Conditions
- Heart Failure
- Keywords
- Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 25 Sep 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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: AI-Based Personalized Self-Management Intervention | Experimental | Device: Experimental: AI-Based Personalized Self-Management Intervention |
| Active Comparator: Usual Care | Active comparator | Behavioral: Behavioral: AI-Based Personalized Self-Management Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 18 years or older. Confirmed diagnosis of chronic heart failure (NYHA 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 informed consent and participate throughout the 12-week study period.
Key exclusion criteria (4 listed)
- NYHA Class IV or end-stage heart failure. Severe cognitive impairment or any condition preventing reliable self-reporting or informed consent.
- 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.
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 |
|---|---|---|
| Experimental: AI-Based Personalized Self-Management InterventionParticipants 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. | Device | Experimental: AI-Based Personalized Self-Management Intervention |
| Behavioral: AI-Based Personalized Self-Management InterventionParticipants receive routine heart failure care, including standard education, outpatient follow-up, and prescribed treatment, without access to the AI-based application. | Behavioural | Active Comparator: Usual Care |
Primary outcome
Primary Outcome Measure 1: Self-Care Behavior (EHFScBS-9)
Time frame: Time Frame: Baseline, Week 6, and Week 12
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.
Primary Outcome Measure 2: Health-Related Quality of Life (RAND-36)
Time frame: Time Frame: Baseline, Week 6, and Week 12
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.
2 secondary outcomes
Secondary Outcome Measure 1: Technology Acceptance of the AI-Based Intervention
Time frame: Time Frame: Week 12
Secondary Outcome Measure 2: Participants' Experiences With the AI-Based Intervention
Time frame: Time Frame: after completion of the 12-week intervention.
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 21 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Salem contact
Mohamed Fakhry Salem, PHD principal investigator
Alexandria University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: AI-Based Personalized Self-Management Intervention and Behavioral: AI-Based Personalized Self-Management Intervention in people with Heart Failure, run by Alexandria University at 2 sites 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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 21 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 2 sites 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 Mohamed Fakhry Salem, PhD (01286038014, Mohamed.Fakhry@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure 1: Self-Care Behavior (EHFScBS-9) (time frame: Time Frame: Baseline, Week 6, and Week 12). The study lists 2 primary outcomes in all. 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 21 Oct 2026.