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

NCT06407154 | Completed

• 1 other identifier: IPA-2024-01
• Study Type: observational
• Target: 578
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• Level of medical service use

  15 May 2024 to 30 September 2024

• Number of participants who died

  15 May 2024 to 30 September 2024

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Location

Related Publications (1)

• Schafer I, Paucke V, Nothacker J, Menzel A, Dopfmer S, Hager K, Hueber S, Karimzadeh A, Kotter T, Loffler C, Muller BS, Scherer M, Luhmann D. Association between psychosocial factors and adverse effects of light-to-moderate ambient heat in patients with chronic diseases: results of the prospective cohort study CLIMATE-II. BMC Med. 2026 Jan 15. doi: 10.1186/s12916-026-04622-4. Online ahead of print.

  PMID: 41540452 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Mood Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Neuromuscular Diseases

Study Officials

• Ingmar Schäfer, PD Dr.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: May 21, 2024
• Primary Completion: September 19, 2024
• Study Completion: September 19, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)