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

Terminated

• Conditions: Diabetes Mellitus, Type 2; Arrhythmias, Cardiac; Asthma; Depressive Disorder; Schizophrenia; Peripheral Nervous System Diseases; Heart Failure; Ischemic Attack, Transient; Renal Insufficiency; Myocardial Infarction

• Registration Number: NCT05961163
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-07-17
• Study First Submitted QC: 2023-07-17
• Study Start: 2023-07-24
• Study First Posted: 2023-07-27
• Status Verified: 2023-09
• Primary Completion: 2023-09-03
• Study Completion: 2023-09-03
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 61

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	Once per week between 29 July - 27 October 2023	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.

Secondary Outcome Measures

Name	Time	Method
Use of medical services	Once per week between 29 July - 27 October 2023	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)
Self-rated health	Once per week between 29 July - 27 October 2023	Measured by visual analogue scale
Reasons for drop out (eg, bad health condition, hospital admission, death)	Once after 27 October 2023	We will ask participants at baseline for permission to contact any confidential contact in case they drop out from the study

Trial Locations

Locations (1)

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany