Skip to main content
OpenTrials
Completed

NCT Number: NCT06407154

Chronical Illness-related Limitations of the Ability to Cope with Rising Temperatures: an Observational Study, 2nd Wave

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Disease Anxiety Disorders Arrhythmias, Cardiac Arterial Occlusive Diseases Arteriosclerosis Asthma Atherosclerosis Autoimmune Diseases Brain Diseases Brain Ischemia Bronchial Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Disease Depressive Disorder Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Heart Diseases Heart Failure Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infarction Ischemia Ischemic Attack, Transient Kidney Diseases Lung Diseases Lung Diseases, Obstructive Male Urogenital Diseases Mental Disorders Metabolic Diseases Mood Disorders Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Artery Disease Peripheral Nervous System Diseases Peripheral Vascular Diseases Pulmonary Disease, Chronic Obstructive Renal Insufficiency Respiratory Hypersensitivity Respiratory Tract Diseases Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Stroke Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Summary score of severity of adverse health effects

    Time frame: 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.

Secondary outcomes

  1. Summary score of participants' implementation of protective behavior against heat

    Time frame: 15 May 2024 to 30 September 2024

    Implementation of protective behavior against heat is measured by agreement to nine statements, each rated from from 0=not at all to 3=completely. Statements include avoiding exposure to sun and heat (4 items), cooling strategies (2 items), clothing adjustment (1 item), avoiding physical exertion (1 item), and drinking enough (1 item). The summary score is calculated by adding the rating of all nine items.

  2. Self-rated health

    Time frame: 15 May 2024 to 30 September 2024

    Subjective health condition on the day of assessment rated by participant on a visual analogue scale between 0 (worst possible) and 100 (best possible).

  3. Level of medical service use

    Time frame: 15 May 2024 to 30 September 2024

    Level of service use is ordinally scaled and defined as 0=no service being used, 1=utilization of medical practices, 2=utilization of emergency departments, and 3=utilization of inpatient care. In case of multiple services being used, the highest category is chosen.

  4. Number of participants who died

    Time frame: 15 May 2024 to 30 September 2024

    Participants are asked at baseline for permission to communicate with any confidential contact person in case they drop out from the study. Data about participants' death are derived from the contact persons' information about the reason for the participants' drop out of the study.

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Acronym: CLIMATE-II

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 9, 2024
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.