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

NCT ID: NCT05961163

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 61 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-24
• Study Completion Date: 2023-09-03

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ingmar Schäfer, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Martin Scherer, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Countries

Germany

References

Jordan A, Nothacker J, Paucke V, Hager KH, Hueber S, Karimzadeh A, Kotter T, Loffler C, Muller BS, Tajdar D, Luhmann D, Scherer M, Schafer I. Association Between Self-Reported Protective Behavior and Heat-Associated Health Complaints Among Patients With Chronic Diseases in Primary Care: Results of the CLIMATE Pilot Cohort Study. JMIR Public Health Surveill. 2024 Nov 4;10:e58711. doi: 10.2196/58711.

Reference Type: DERIVED

PMID: 39496153 (View on PubMed)

Other Identifiers

IPA-2023-01

Identifier Type: -

Identifier Source: org_study_id