AI-Assisted Personalized Heat-Risk Alerts
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational University of Medical Sciences, Pakistan
About this trial
This two-arm randomized controlled trial will evaluate whether an artificial intelligence-assisted personalized heat-risk alert system reduces heat-related illness symptom burden among adults with chronic conditions. The intervention will integrate prespecified clinical characteristics with the Pakistan Meteorological Department's same-day forecast maximum temperature to classify individual heat-related acute clinical-event risk and deliver personalized alerts through a mobile application. The control group will receive a generic PMD heat-health advisory through the same application.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older attending the outpatient department of the selected tertiary-care hospital during the recruitment period.
Have a documented diagnosis of at least one chronic non-communicable disease associated with increased susceptibility to heat-related illness, including hypertension, type 2 diabetes mellitus, chronic kidney disease, cardiovascular disease, or obesity (BMI ≥30 kg/m²).
Have access to a personal smartphone capable of receiving study heat-risk alert notifications.
Be able to read Urdu or English, or have a household member/caregiver available to read and explain study alerts when required.
Disqualifiers
Patients requiring immediate emergency treatment or hospital admission at the time of recruitment.
Individuals with severe cognitive impairment, dementia, psychotic illness, or another medical condition that limits their ability to understand study procedures or provide informed consent.
Patients with terminal illness or those receiving palliative care.
Individuals with severe visual, hearing, or communication impairments that prevent effective receipt of the study alert intervention and outcome assessment without a reliable caregiver.
Trial design
Design model
Parallel
Treatments tested in this trial
AI-Assisted Personalized Heat-Risk Alert System
BehavioralA mobile application-based heat-health alert system that uses a locked AI prediction engine to integrate prespecified individual clinical characteristics with the Pakistan Meteorological Department's same-day forecast maximum temperature (≥36°C) and classify participants into low, moderate, or high heat-related acute clinical-event risk categories. The application delivers corresponding personalized heat-health messages.
Generic PMD Heat-Health Advisory
BehavioralGeneric Pakistan Meteorological Department heat-health advisory delivered through the same patient-facing mobile application when the same-day forecast maximum temperature is ≥36°C, without AI-based risk stratification or individualized clinical personalization.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: AI-Assisted Personalized Heat-Risk AlertExperimental treatment 1 intervention
Group B: Generic PMD Heat-Health AdvisoryActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Heat-Related Illness Symptom Score (HRISS)
The total HRISS score ranges from 0 to 20, based on 10 heat-related illness symptom items assessed for the preceding 7 days; higher scores indicate greater heat-related illness symptom burden. HRISS will be assessed at baseline and Week 6, with the primary analysis comparing Week-6 HRISS between groups after adjustment for baseline HRISS.
Time frame
Baseline and six weeks after randomizationSecondary outcomes
1
Heat-Health Protective Behavior Checklist (HPBC)
The total score on the 10-item Heat-Health Protective Behavior Checklist (HPBC) ranges from 0 to 10, with higher scores indicating greater adoption of heat-protective behaviors. HPBC will be assessed at baseline and Week 6, with the between-group comparison based on the Week-6 score adjusted for baseline.
Time frame
Baseline and six weeks after randomization2
Heat-Health Knowledge, Attitudes and Practices (KAP) Score
Heat-health knowledge, attitudes, and practices will be assessed using the study's 20-item heat-health KAP questionnaire. The questionnaire will be administered at baseline and Week 6, with the prespecified between-group comparison based on the Week 6 assessment, adjusted for baseline values.
Time frame
Baseline and six weeks after randomization3
Heat-related hospital admissions
Number of unplanned hospital admissions attributable to heat-related illness during the six-week intervention period.
Time frame
From randomization through six weeksSponsors and contacts
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Source ClinicalTrials.gov