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

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

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.

Study Overview

• Status: Completed
• Conditions: Depressive Disorder; Myocardial Infarction; Heart Failure; Stroke; Coronary Disease; Diabetes Mellitus, Type 2; Renal Insufficiency; Diabetes Mellitus, Type 1; Schizophrenia; Pulmonary Disease, Chronic Obstructive; Peripheral Nervous System Diseases; Anxiety Disorders; Ischemic Attack, Transient; Arrhythmias, Cardiac; Asthma; Peripheral Artery Disease

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 578

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany
    • Universitätsklinikum Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study is located in different sites in Germany. Patients from approximately 80 GP practices will be included. In each practice, eligible patients receive a flyer including a QR-Code and a short link to register for the online study. After documenting informed consent within the application, patients fill out the baseline questionnaire and receive invitations for 12 subsequent assessments of symptoms by email. The investigators estimated that approximately 3,200 patients will be contacted. From experience with similar studies the investigators anticipated a response rate of 20% (=640 patients).

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Summary score of severity of adverse health effects	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.	15 May 2024 to 30 September 2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Summary score of participants' implementation of protective behavior against heat	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.	15 May 2024 to 30 September 2024
Self-rated health	Subjective health condition on the day of assessment rated by participant on a visual analogue scale between 0 (worst possible) and 100 (best possible).	15 May 2024 to 30 September 2024
Level of medical service use	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.	15 May 2024 to 30 September 2024
Number of participants who died	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.	15 May 2024 to 30 September 2024

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Ingmar Schäfer, PD Dr., Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2024
• Primary Completion (Actual): September 19, 2024
• Study Completion (Actual): September 19, 2024

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: May 6, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Heart Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Glucose Metabolism Disorders; Brain Ischemia; Infarction; Necrosis; Lung Diseases, Obstructive; Mood Disorders; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Myocardial Ischemia; Ischemia; Schizophrenia; Pulmonary Disease, Chronic Obstructive; Ischemic Attack, Transient; Anxiety Disorders; Diabetes Mellitus, Type 2; Depressive Disorder; Diabetes Mellitus; Peripheral Nervous System Diseases; Diabetes Mellitus, Type 1; Peripheral Arterial Disease; Renal Insufficiency; Nervous System Diseases; Coronary Disease; Myocardial Infarction; Arrhythmias, Cardiac
• Other Study ID Numbers: IPA-2024-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will be available from the corresponding authors of study publications upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No