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临床试验/NCT06407154
NCT06407154已完成不适用

Chronical Illness-related Limitations of the Ability to Cope with Rising Temperatures: an Observational Study, Second Wave (CLIMATE-II)

Universitätsklinikum Hamburg-Eppendorf1 个研究点 分布在 1 个国家目标入组 578 人开始时间: 2024年5月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
578
试验地点
1
主要终点
Summary score of severity of adverse health effects

研究概览

简要总结

The CLIMATE-II Observational Study examines to what extent chronically ill patients experience adverse health effects because of heat and whether the patients' specific health behavior, somatosensory amplification, risk and benefit perception, self-efficacy, health literacy, degree of urbanisation of the patients' administration district and characteristics of the patients' neighborhood are associated with these effects.

详细描述

The CLIMATE-II Observational Study aims to analyse to what extent chronically ill patients experience adverse health effects because of heat and whether the patients' specific health behavior, self-efficacy, or other factors are associated with these effects. This cohort study is based on an online survey of patients with chronic illness who are recruited in GP practices across all regions of Germany. After the baseline assessment, participants fill out symptom diaries on 12 specific days of observation over a maximum period of 12 weeks. The specific days of observation are selected based on the maximum temperature that can be expected within the respective weeks. The weather forecast will be checked every Thursday. If, in the upcoming 4 days, the maximum temperature is expected to exceed 30°C, the warmest day in this time frame will be chosen. Otherwise, the weather forecast will be checked again on Monday to choose the warmest of the remaining days of the week. On each day of observation, patients are notified by email at 6 pm.

Baseline assessment includes socio-demographic data, chronic diseases, health behavior, somatosensory amplification, perceived risk for adverse health effects because of heat, perceived benefit of protective behavior against heat, perceived social support, self-efficacy, and health literacy. Local data on temperatures and humidity will be assessed by the measurement stations of Germany's National Meteorological Service. Degree of urbanisation of administration districts is provided by the German Federal Institute for Research on Building, Urban Affairs and Spatial Development. Data will be analyzed by multivariable, multilevel regression analyses adjusted for possible confounders and random effects on the administration district and practice within administration district level.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • being 18 years or older
  • at least one of the following conditions: Coronary Heart Disease; Myocardial Infarction; Heart Failure; Cardiac Arrhythmias; Peripheral Artery Disease; Stroke; Transient Ischemic Attack; Diabetes Mellitus (Type 1 or 2); Chronic Obstructive Pulmonary Disease; Asthma; Renal Insufficiency; Depressive Disorder; Anxiety Disorders; Schizophrenia; Peripheral Nervous System Diseases.

排除标准

  • no capacity to consent
  • severe visual impairment
  • insufficient German language skills
  • not able to use internet browser (eg, lack of hardware)

结局指标

主要结局

Summary score of severity of adverse health effects

时间窗: 15 May 2024 to 30 September 2024

Observed adverse health effects include nausea, vomiting, tiredness/fatigue, vertigo, circulation problems/syncopes, muscle cramps, headache, extrasystoles, palpitations, edemas, shortness of breath, depressive mood, anxiety, and mental confusion. The severity in each symptom category is defined by the degree of limitations in usual activities from 0=none to 4=very severe. The summary score is calculated by adding the severity of each symptom category.

次要结局

  • Level of medical service use(15 May 2024 to 30 September 2024)
  • Summary score of participants' implementation of protective behavior against heat(15 May 2024 to 30 September 2024)
  • Self-rated health(15 May 2024 to 30 September 2024)
  • Number of participants who died(15 May 2024 to 30 September 2024)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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