Beat the Heat Boston

NCT06982339 | Recruiting

• 2 other identifiers: IRB25-03661P20TW013028-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this stepped wedge trial is to assess the practical effects of air conditioners on hot weather impacts among older adults. The main questions it aims to answer are: How does the presence of an air conditioning unit affect heat stress, heat strain, mental health, and healthcare utilization among older adults who did not previously have access to air conditioning? How, and in what conditioners, do older adults use air conditioning once it is installed in their home? Researchers will compare participants in arms with (A) and without (B) air conditioning units in the first summer season; this will allow them to assess the effect of air conditioners. In the second summer season, both arms will have air conditioning units, but those in the year two distribution arm (B) will receive an electricity subsidy, while those in the year one AC distribution arm (A) will not, allowing researchers to assess the effect of an electricity subsidy. Participants will be randomized to receive an air conditioner and financial support for electricity costs in either the first summer season or the second summer season of the study.

• Heat stress, heat strain, mental health, and healthcare utilization will be assessed via participant survey.
• Air conditioner utilization will be assessed via continuous load monitoring devices.
• Indoor air temperature will be assessed via continuous data loggers.

Conditions

Heat Strain; Heat Stroke, Heat Exhaustion; Hot Weather; Adverse Effect; Heat Effect; Heat Stress; Heat Exposure

Keywords

Cooling; Air conditioner; Heat related illness; stepped wedge

Outcome Measures

Primary Outcomes (1)

• Environmental Symptoms Questionnaire (ESQ-IV)

  The primary outcome will be a two-sample t-test for differences in means in the treatment and control groups in responses to the Environmental Symptoms Questionnaire (ESQ-IV). We will assess self-reported health impacts across all sites using a modified (truncated) version of the Environmental Symptoms Questionnaire (ESQ-IV), referred to as the Heat Stress Symptoms Questionnaire. Originally developed for assessing the health impacts of environmental exposures (Sampson et al, 1993), the ESQ-IV has been validated for assessing health impacts associated with heat illness in soldiers (Johnson \& Merullo, 1993). More recently, smaller subsets of the ESQ-IV's questions have served as a health endpoint for assessing the impacts of heat stress and acclimatization in the general population and older adults (McGarr et al, 2023; Manning et al, 2023). In an urban population, a question using similar language in a simplified format was used to assess prior experiences of heat-related illness (Card

  Difference in self-reported symptoms on HSSQ administered in the late summer season, 2-12 weeks after enrollment.

Secondary Outcomes (1)

• Air Conditioner Utilization

  From enrollment to study completion, approximately 2 years.

Study Arms (2)

Early Air Conditioning

EXPERIMENTAL

Year 1: Participants receive a window AC unit and a financial subsidy for electricity. Year 2: Participants continue to have their AC unit, but do not receive a financial subsidy for electricity.

Other: Air Conditioner; Other: Electricity subsidy

Delayed Air Conditioning

NO INTERVENTION

Year 1: No intervention. Year 2: Participants receive an AC unit along with a financial subsidy for electricity.

Interventions

Air Conditioner OTHER

Air conditioners will be window-mounted units powered by 110v AC.

Early Air Conditioning

Electricity subsidy OTHER

Electricity subsidies will consist of a single block subsidy of USD 100, intended to provide support for the electricity costs associated with operating an air conditioning unit.

Early Air Conditioning

Eligibility Criteria

• Age: 55 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• reside in Roxbury, Dorchester, East Boston or Mattapan MA
• age 55-95 years old
• speak English or Spanish
• do not have air conditioning in the home
• living with at least one of the following conditions: chronic CVD (hypertension, hyperlipidemia, diabetes, history of stroke or myocardial infarction, atrial fibrillation, or heart failure), chronic pulmonary disease (asthma, COPD/emphysema, interstitial lung disease), chronic neurologic disease (stroke, Parkinson's disease, or other chronic neurologic conditions), chronic mental health conditions (including anxiety disorder, major depression, bipolar disorder), and/or history of hospitalization (defined as spending at least one night in the hospital) for any reason within the past three years.

You may not qualify if:

• \- Lack a location in their home suitable for installation of the AC unit provided during the research study.

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Harvard TH Chan School of Public Health

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Heat Stress Disorders; Heat Stroke; Heat Exhaustion

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Gary Adamkiewicz Associate Professor of Environmental Health and Exposure Disp., PhD, MPH, MS

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caleb Dresser Assistant Professor in Environmental Health, MD MPH

CONTACT

(617) 446-3248; beattheheatboston@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Environmental Health and Exposure Disparities

Model Details: This study follows a stepped wedge randomized controlled trial (SW-RCT) design to evaluate the health and environmental impacts of air conditioning among older adults with chronic health conditions. A total of 100 participants are randomized into two groups: Arm A (Early AC Group): Receives a window AC unit in Year 1, along with a financial subsidy for electricity.. Arm B (Delayed AC Group): Receives an identical AC unit in Year 2, along with a financial subsidy for electricity. In Year 1, participants in Arm A (AC) are compared to those in Arm B (no AC) to assess the direct effect of AC access. In Year 2, both arms have AC units, but only Arm B receives the electricity subsidy, allowing evaluation of cost as a barrier to use.

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 21, 2025
• Study Start: May 19, 2025
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: January 22, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available at the time of publication of study results.
• Access Criteria: Data will be available upon reasonable request.

Locations

US (1)