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

Stroke Clinical Trial

— CLIMATE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05961163
• Other study ID #: IPA-2023-01
• Status: Terminated
• Start date: July 24, 2023
• Est. completion date: September 3, 2023

Study information

• Verified date: September 2023
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

The CLIMATE Observational Study aims to analyse to what extent chronically ill patients experience adverse health effects because of heat and whether the patients' specific efforts, 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 one specific day of observation per week over a maximum period of 12 weeks. The specific days of observation within the time frame between 29 July and 8 September are selected based on the maximum temperature that can be expected within the respective weeks. The weather forecast will be checked every Friday. 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 Tuesday to choose the warmest of the remaining days of the week. The specific days of observation within the time frame between 9 September and 27 October are randomly selected. On each day of observation, patients are notified by email at 6 pm.

Baseline assessment includes socio-demographic data, health-related quality of life, efforts against adverse effects of heat, somatosensory amplification, self-efficacy, health literacy and commitment to the GP. 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. Additionally, small scale data on population density, number of one-person households, unemployment rates and other neighbourhood characteristics are provided by the German Statistical Offices. 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: Terminated
• Enrollment: 61
• Est. completion date: September 3, 2023
• Est. primary completion date: September 3, 2023
• 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 (NYHA stage II or higher); Cardiac Arrhythmias (treated with medication); Peripheral Artery Disease (Fontaine-Ratschow stage II or higher); Stroke; Transient Ischemic Attack; Diabetes Mellitus (Type 1 or 2 treated with oral medication or insulin); Chronic Obstructive Pulmonary Disease (GOLD stage 2 or higher); Asthma (GINA stage II or higher); Renal Insufficiency (KDIGO stage III or higher), Depressive Disorder (treated with medication); Anxiety Disorders (treated with medication), Schizophrenia (treated with medication); Peripheral Nervous System Diseases (with regularly or persistently occurring symptoms).

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	Composite index of nausea, vomiting, tiredness/fatigue, vertigo, circulation problems/syncopes, muscle cramps, headache, extrasystoles, palpitations, edemas, shortness of breath, depressive mood, anxiety, mental confusion	The severity in each symptom category is defined by the degree of limitations in usual activities. The composite index expresses the highest severity within any symptom category.	Once per week between 29 July - 27 October 2023
Secondary	Self-rated health	Measured by visual analogue scale	Once per week between 29 July - 27 October 2023
Secondary	Use of medical services	As part of the symptom diary, we will also assess the use of medical services at the specific day of observation (i.e., ambulant care, emergency care, hospital admission)	Once per week between 29 July - 27 October 2023
Secondary	Reasons for drop out (eg, bad health condition, hospital admission, death)	We will ask participants at baseline for permission to contact any confidential contact in case they drop out from the study	Once after 27 October 2023