Mitigation of Health Effects in Older Adults With Hypertension by Reducing Exposure to Heat and Air Pollution

Официальное название

Innovative Solutions Across the MEDiterranean for Mitigation of Climate Change-related heaLth rIsks and Enhancing Health systeM Resilience

Обзор

The goal of this clinical trial is to assess the effectiveness of an intervention (combination of behavioural recommendations and technical measures) in reducing personal exposure to heat and air pollution and related health effects in older adults with hypertension. The main questions it aims to answer are: * Does the intervention (combination of behavioral recommendations for heat mitigation) reduce personal ambient temperature exposure, measured using a wearable device (iButton)? * Does the intervention (combination of behavioral recommendations for air pollution mitigation and use of indoor air cleaners) reduce indoor exposure to air pollution, measured using indoor air quality sensors (Purple Air)? * Does the intervention (combination of behavioral recommendations for heat mitigation) improve the abnormalities in circadian blood pressure variation experienced by older adults with hypertension, assessed using advanced actigraphy? Researchers will compare measurements between older adults with hypertension carrying out their daily activities in the absence of intervention (control group), those carrying out their daily activities with behavioural recommendations (recommendation intervention group) and those carrying out their daily activities with both behavioural recommendations for heat mitigation and continuous use of indoor air cleaners in their house (heat and air pollution mitigation intervention group) to see if changes in temperature exposure and sleep are different between intervention groups. Participants will: * Wear the wearable devise for continuous personal ambient temperature monitoring (ibutton) daily for a period of three months * Have their core temperature measured using an eCelsius medical capsule in three repeated assessments * Have their blood pressure, oxygen saturation, ECG and heart rate variability measured using 24-hour advanced actigraphy in three repeated assessments * Provide samples of urine and blood biomarkers in three repeated assessments.

Вмешательства

• Поведенческое Heat intervention
  The participants in this group of intervention will receive timely personal alerts for high temperatures and specific recommendations to reduce exposure to heat by changing patterns of time spent and physical activity performed outdoors, regulating indoor temperature using fans and/or air conditioning devices, as well as recommendations for mitigation of heat-related health effects (hydration, body cooling) in written and animated format, through mobile phones, web application and online tools t
• Поведенческое Heat and air pollution mitigation intervention
  The participants in this intervention group will receive alerts and recommendations as in group "Heat intervention" and, in addition, continuously use air cleaners with HEPA filters for removing PM from indoor air in their residences and workplaces

Первичные конечные точки

• Percentage dipping in night-time systolic blood pressure (SBP) [Срок оценки: Percentage dipping (Dipping %=([Mean Daytime SBP-Mean Night-time BP]/Mean Daytime SBP)×100) in night-time SBP will be assessed at baseline, middle (after 1 month), and at end of the observation period (after 2 months).]

Вторичные конечные точки (12)

• Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: The PSQI will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months)]
• Sleep-wake pattern [Срок оценки: Daily measurements - for the whole duration of follow-up (2 months)]
• Sleep-Wake self-reported evaluation [Срок оценки: The sleep-wake self-reported evaluation will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).]]
• Hamilton Anxiety Rating Scale [Срок оценки: The Hamilton Anxiety Rating Scale will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months)]
• Daily heart rate [Срок оценки: Daily measurements - for the whole duration of follow-up (2 months)]
• Heart Rate [Срок оценки: Heart Rate will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months).]
• Heart Rate Variability [Срок оценки: The heart rate variability will be assessed at baseline, middle (after 1 month), and at end of observation period (after 2 months)]
• The personal ambient temperature profile of all participants [Срок оценки: Daily measurements - for the whole duration of follow-up (2 months)]
• Wet-bulb globe temperature (WGBT) [Срок оценки: Daily measurements - for the whole duration of follow-up (2 months)]
• Humidity [Срок оценки: Daily measurements - for the whole duration of follow-up (2 months)]
• Indoor concentration levels of PM2.5 and PM10 at residence [Срок оценки: Daily measurements - for the whole duration of follow-up (2 months)]
• Number of daily steps [Срок оценки: Daily measurements - for the whole duration of follow-up (2 months)]

Критерии участия

Критерии включения

• Aged ≥65 years
• Living in Barcelona (Spain) or Nicosia (Cyprus) metropolitan areas
• Have a physician's diagnosis of arterial hypertension
• Receive daily anti-hypertensive medication
• Clinically stable

Критерии исключения

• Currently smoking
• Presence of any smoking residents in the household
• Not residing at the household for at least 5 days a week
• Planning to move from the current home within the next two months
• No access to Wi-Fi or 4G/5G mobile phone
• Severe chronic conditions (congestive heart failure, ischemic heart disease, significant valvular heart disease, diabetes mellitus type 2 (DM2), inflammatory diseases, renal failure, or active cancer)
• Illicit drugs abuse
• Alcohol abuse
• Psychiatric disorders
• Severe mental disability that interferes with answering questions or following instructions

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Cyprus · 1 центр

• Medical School, University of Cyprus — Nicosia

Испания · 1 центр

• Vall d'Hebron Institut de Recerca (VHIR) — Barcelona

Публикации

• Hu J, Xue X, Xiao M, Wang W, Gao Y, Kan H, Ge J, Cui Z, Chen R. The acute effects of particulate matter air pollution on ambulatory blood pressure: A multicenter analysis at the hourly level. Environ Int. 2021 Dec;157:106859. doi: 10.1016/j.envint.2021.106859. Epub 2021 Sep 9. PMID 34509047
• Modesti PA, Morabito M, Bertolozzi I, Massetti L, Panci G, Lumachi C, Giglio A, Bilo G, Caldara G, Lonati L, Orlandini S, Maracchi G, Mancia G, Gensini GF, Parati G. Weather-related changes in 24-hour blood pressure profile: effects of age and implications for hypertension management. Hypertension. 2006 Feb;47(2):155-61. doi: 10.1161/01.HYP.0000199192.17126.d4. Epub 2005 Dec 27. PMID 16380524
• Kario K, Hoshide S, Mizuno H, Kabutoya T, Nishizawa M, Yoshida T, Abe H, Katsuya T, Fujita Y, Okazaki O, Yano Y, Tomitani N, Kanegae H; JAMP Study Group. Nighttime Blood Pressure Phenotype and Cardiovascular Prognosis: Practitioner-Based Nationwide JAMP Study. Circulation. 2020 Nov 10;142(19):1810-1820. doi: 10.1161/CIRCULATIONAHA.120.049730. Epub 2020 Nov 2. PMID 33131317
• Tabara Y, Matsumoto T, Murase K, Nagashima S, Hirai T, Kosugi S, Nakayama T, Wakamura T, Chin K, Matsuda F; and the Nagahama study group. Seasonal variation in nocturnal home blood pressure fall: the Nagahama study. Hypertens Res. 2018 Mar;41(3):198-208. doi: 10.1038/s41440-017-0003-3. Epub 2018 Jan 30. PMID 29382900

Идентификаторы

NCT: NCT07606859 · 101156653.LL3.OH · 101156653

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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