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NCT Number: NCT07825831

AI-Assisted Personalized Heat-Risk Alerts

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gondal Medical Complex

Gujranwala, Punjab Province, 52250, Pakistan

Location status: Recruiting

About this study

Extreme heat poses increased health risks for adults living with chronic conditions. Conventional heat-health warning systems generally provide population-level advisories and may not account for individual clinical vulnerability. This study will evaluate an artificial intelligence-assisted personalized heat-risk alert system designed to integrate individual clinical characteristics with environmental exposure information.

The trial will enroll 120 adults with hypertension, type 2 diabetes, chronic kidney disease, cardiovascular disease, and/or obesity from the outpatient department of a selected tertiary-care hospital in Gujranwala, Pakistan. Participants will be randomized 1:1 to an intervention or control group and followed for six weeks.

On days when the Pakistan Meteorological Department same-day forecast maximum temperature is ≥36°C, the intervention system will process prespecified clinical characteristics and the temperature forecast through a locked AI Prediction Model. Participants will be classified into low, moderate, or high heat-related acute clinical-event risk categories, with corresponding personalized heat-health messaging. The control group will receive a generic PMD heat-health advisory through the same patient-facing mobile application without AI-based risk stratification or clinical personalization.

The primary outcome is Heat-Related Illness Symptom Score (HRISS) at Week 6. Secondary outcomes include heat-protective behaviors, heat-health knowledge, attitudes and practices, heat-related emergency department visits and hospital admissions, and application engagement. The AI model will be developed and internally validated using a separate historical hospital dataset containing heat-related emergency department visits/admissions and will be locked before intervention delivery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Be willing and able to provide written informed consent.
  • Intend to remain within the study catchment area for the duration of the six-week study period to facilitate follow-up.

Exclusion criteria

  • 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.
  • Pregnant women, because pregnancy has distinct physiological responses to heat exposure and would require separate clinical risk stratification beyond the scope of this study.
  • Participants currently enrolled in another clinical trial or structured behavioral intervention related to heat-health, climate adaptation, or chronic disease self-management.
  • Participants who are unable or unwilling to comply with study procedures or complete the required follow-up assessment.

Treatment and study plan

AI-Assisted Personalized Heat-Risk Alert System

Behavioral

A 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

Behavioral

Generic 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.

Primary outcomes

  1. Heat-Related Illness Symptom Score (HRISS)

    Time frame: Baseline and six weeks after randomization

    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.

Secondary outcomes

  1. Heat-Health Protective Behavior Checklist (HPBC)

    Time frame: Baseline and six weeks after randomization

    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.

  2. Heat-Health Knowledge, Attitudes and Practices (KAP) Score

    Time frame: Baseline and six weeks after randomization

    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.

  3. Heat-related hospital admissions

    Time frame: From randomization through six weeks

    Number of unplanned hospital admissions attributable to heat-related illness during the six-week intervention period.

Study contacts

Contact information is provided by the study sponsor or research team.

Mubra Noor, MS Public Health

CONTACT

[email protected]

+92- 321-6143378

Sponsors and collaborators

Lead sponsor

National University of Medical Sciences, Pakistan

Other

Registry information

Official study title

Effectiveness of an Artificial Intelligence-Assisted Personalized Heat-Risk Alert System in Reducing Heat-Related Illness Among Adults With Chronic Conditions: A Randomized Controlled Trial in Pakistan

Acronym: HEAT-CARE

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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