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

Stroke Clinical Trial

— CLIMATE-II  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06407154
• Other study ID #: IPA-2024-01
• Status: Recruiting
• Start date: May 21, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: June 2024
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Valentina Paucke, M.Sc.
• Phone: +49-40-7410-53292
• Email: va.paucke[@]uke.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 640
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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