- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07500545
Community Health Adaptation & Resilience Mobilization (CHARM) HeatWise (CHARM)
April 14, 2026 updated by: Public Health Institute, California
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.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
580
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Scarlet Sands-Bliss, MS
- Phone Number: 510-285-5500
- Email: info@trackingcalifornia.org
Study Locations
-
-
California
-
Lakeport, California, United States, 95453
- Recruiting
- Big Valley Rancheria
-
Contact:
- Aliza Gevirtz
- Phone Number: 707-533-0071
- Email: agevirtz@bvr-nsn.gov
-
Principal Investigator:
- Sarah Ryan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immediate HEATWise
Intervention shortly after enrollment
|
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.
|
|
Other: Delayed HEATWise)
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
3-months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in individual and community resilience scores: "Communities Advancing Resilience Toolkit"
Time Frame: Baseline to 15-months post-enrollment (12-month follow-up period)
|
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)
|
Baseline to 15-months post-enrollment (12-month follow-up period)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Michelle Wong, Public Health Institute
- Principal Investigator: Susan Paulukonis, Public Health Institute
- Principal Investigator: Sarah Ryan, Big Valley Band of Pomo Indians
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 15, 2026
Primary Completion (Estimated)
June 2, 2028
Study Completion (Estimated)
June 2, 2028
Study Registration Dates
First Submitted
March 23, 2026
First Submitted That Met QC Criteria
March 23, 2026
First Posted (Actual)
March 30, 2026
Study Record Updates
Last Update Posted (Actual)
April 17, 2026
Last Update Submitted That Met QC Criteria
April 14, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB #I25-022
- OT2HL158287 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Time Frame
Following publication of the primary results or upon study completion, consistent with the approved Data Management and Sharing Plan.
IPD Sharing Access Criteria
Data will be available to qualified researchers through ICPSR under applicable data use agreements.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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