Heat IllnessCHARMNCT07500545
Community Health Adaptation & Resilience Mobilization (CHARM) HeatWise
A study testing CHARM HeatWise in people with Heat Illness, run by Public Health Institute, California at 1 site in United States.
Trial summary
Extreme heat events pose serious health risks, especially for communities with limited access to cooling, transportation, or social support. This study pilots and tests HEATwise, a heat preparedness program delivered at trusted community centers in Lake County, California, serving older adults, Tribal members, and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heat Illness
- What is being tested?
- CHARM HeatWise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 580 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2026to 2 Jun 2028
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligible participants are adults (≥18 years) who have resided in Lake County for at least 6 months, are able to access a phone for study communications, and are willing to provide a valid secondary contact for the duration of the study.
Who cannot join
- Participants must also be a recognized member or affiliate of a articipating site, referred by the site, or reside within 5 miles of the site. Individuals are excluded if another household member is already enrolled in the study, if they cannot provide a secondary or emergency contact, are unable to independently complete study activities, or plan to be away for 15 or more consecutive days during the intervention period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community Health Adaptation & Resilience Mobilization (CHARM) Lake County
Extreme heat events pose serious health risks, especially for communities with limited access to cooling, transportation, or social support. This study pilots and tests HEATwise, a heat preparedness program delivered at trusted community centers in Lake County, California, serving older adults, Tribal members, and people experiencing housing or economic hardship. HEATwise is a 12-week program which includes a group workshop on heat risks and preparedness, one-on-one resource navigation, a community celebration event, and a cooling and emergency supply kit. The pilot phase (2026) will assess feasibility and acceptability at three sites with approximately 60 participants. The full trial (2027-2028) will randomly assign eight sites to receive HEATwise immediately or after a delay, measuring whether the program increases protective behaviors, reduces heat-related symptoms, and strengthens resilience over 12 months.
- Conditions
- Heat Illness
- Being tested
- CHARM HeatWise
- Keywords
- Extreme Heat, Rural Preparedness, Community Engaged Research, Community-Based Participatory Research
- Medical subject headings
- Heat Stress Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHARM HeatWiseBehavioural
HEATWise consists of structured, facilitator-led training sessions on extreme heat preparedness and response, distribution of heat resilience kits, and community engagement activities designed to promote protective behaviors. The intervention is delivered at the cluster (site) level in community-based settings and focuses on reducing risk of heat-related illness and improving individual and community resilience.
| Study group | Role | What they receive |
|---|---|---|
| Immediate HEATWise | Experimental | Intervention shortly after enrollment Receives: Behavioral: CHARM HeatWise |
| Delayed HEATWise) | Other | Treatment as usual. These sites will offer the HEATwise program the following year, after the intervention is complete, and all waitlist control participants will be invited to participate. Receives: Behavioral: CHARM HeatWise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Symptoms
Change in self-reported heat-illness symptoms: "Self-reported heat stress measure". Range 0-8, with higher scores indicating higher heat stress
Measured: 3-months post-intervention
Secondary outcomes (1)
Change in individual and community resilience scores: "Communities Advancing Resilience Toolkit"
35 items community resilience measure, outcome is mean score from 1-5 (strongly disagree-strongly agree); 19 items individual resilience measure - outcome is mean score from 1-5 (strongly disagree-strongly agree)
Measured: Baseline to 15-months post-enrollment (12-month follow-up period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start29 Mar 2026
- Primary completion2 Jun 2028 (estimated)
- Study completion2 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heat IllnessStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a cluster randomized, parallel assignment, waitlist-controlled design. Community-based sites serving rural, underserved populations are randomized to either immediate implementation of the Helping Everyone Adapt Together-Wise (HEATWise) or to a waitlist control condition. Participants at control sites complete baseline and follow-up assessments during the six-month evaluation period and receive the intervention after primary outcome data collection is completed. Randomization occurs at the site level to reduce contamination, and analyses account for clustering.
- Masking
- None (open label)
- Enrolment
- 580 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Public Health Institute, California
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Michelle Wong, Principal investigator, Public Health InstituteSusan Paulukonis, Principal investigator, Public Health InstituteSarah Ryan, Principal investigator, Big Valley Band of Pomo Indians
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500545
- Sponsor's protocol ID
- IRB #I25-022
- Other IDs
- OT2HL158287
- Acronym
- CHARM
- Status last verified
- Aug 2026
- First submitted
- 23 Mar 2026
- Last updated
- 25 Aug 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 primary and secondary outcomes, along with codebooks and metadata, will be shared via ICPSR following publication of the primary results or study completion, in accordance with the approved Data Management and Sharing Plan.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Health Adaptation & Resilience Mobilization (CHARM) Lake County
- ClinicalTrials.gov ID
- NCT07500545
- Acronym / sponsor ID
- CHARM / IRB #I25-022
- Conditions
- Heat Illness
- Keywords
- Extreme Heat, Rural Preparedness, Community Engaged Research, Community-Based Participatory Research
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- Public Health Institute, CaliforniaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 29 Mar 2026 (actual)
- Primary completion
- 2 Jun 2028 (estimated)
- Study completion
- 2 Jun 2028 (estimated)
- First posted
- 30 Mar 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.
Extreme heat events pose serious health risks, especially for communities with limited access to cooling, transportation, or social support. This study pilots and tests HEATwise, a heat preparedness program delivered at trusted community centers in Lake County, California, serving older adults, Tribal members, and people experiencing housing or economic hardship. HEATwise is a 12-week program which includes a group workshop on heat risks and preparedness, one-on-one resource navigation, a community celebration event, and a cooling and emergency supply kit. The pilot phase (2026) will assess feasibility and acceptability at three sites with approximately 60 participants. The full trial (2027-2028) will randomly assign eight sites to receive HEATwise immediately or after a delay, measuring whether the program increases protective behaviors, reduces heat-related symptoms, and strengthens resilience over 12 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a cluster randomized, parallel assignment, waitlist-controlled design. Community-based sites serving rural, underserved populations are randomized to either immediate implementation of the Helping Everyone Adapt Together-Wise (HEATWise) or to a waitlist control condition. Participants at control sites complete baseline and follow-up assessments during the six-month evaluation period and receive the intervention after primary outcome data collection is completed. Randomization occurs at the site level to reduce contamination, and analyses account for clustering.
| Arm | Type | Receives |
|---|---|---|
| Immediate HEATWise | Experimental | Behavioral: CHARM HeatWiseIntervention shortly after enrollment |
| Delayed HEATWise) | Other | Behavioral: CHARM HeatWiseTreatment as usual. These sites will offer the HEATwise program the following year, after the intervention is complete, and all waitlist control participants will be invited to participate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible participants are adults (≥18 years) who have resided in Lake County for at least 6 months, are able to access a phone for study communications, and are willing to provide a valid secondary contact for the duration of the study.
Key exclusion criteria (1 listed)
- Participants must also be a recognized member or affiliate of a articipating site, referred by the site, or reside within 5 miles of the site. Individuals are excluded if another household member is already enrolled in the study, if they cannot provide a secondary or emergency contact, are unable to independently complete study activities, or plan to be away for 15 or more consecutive days during the intervention period.
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 |
|---|---|---|
| CHARM HeatWiseHEATWise consists of structured, facilitator-led training sessions on extreme heat preparedness and response, distribution of heat resilience kits, and community engagement activities designed to promote protective behaviors. The intervention is delivered at the cluster (site) level in community-based settings and focuses on reducing risk of heat-related illness and improving individual and community resilience. | Behavioural | Delayed HEATWise), Immediate HEATWise |
Primary outcome
Change in Symptoms
Time frame: 3-months post-intervention
Change in self-reported heat-illness symptoms: "Self-reported heat stress measure". Range 0-8, with higher scores indicating higher heat stress
1 secondary outcome
Change in individual and community resilience scores: "Communities Advancing Resilience Toolkit"
Time frame: Baseline to 15-months post-enrollment (12-month follow-up period)
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 25 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the primary and secondary outcomes, along with codebooks and metadata, will be shared via ICPSR following publication of the primary results or study completion, in accordance with the approved Data Management and Sharing Plan.
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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. This study is not recruiting at the moment.
Michelle Wong principal investigator
Public Health Institute
Susan Paulukonis principal investigator
Public Health Institute
Sarah Ryan principal investigator
Big Valley Band of Pomo Indians
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHARM HeatWise in people with Heat Illness, run by Public Health Institute, California at 1 site in United States.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 25 Aug 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 United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Symptoms (time frame: 3-months post-intervention). 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 25 Aug 2026.