An observational study in Coronary Disease, Myocardial Infarction and Heart Failure, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-15.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Observational
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.
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.
2,867 studies on the registry are indexed under Coronary Disease; 309 are open to participants now.
This study's enrollment of 578 is above the median of 465 across 958 observational studies indexed under Coronary Disease.
Browse Coronary Disease studies →Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 415 studies on the registry; 85 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Time frame: 15 May 2024 to 30 September 2024
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.
Time frame: 15 May 2024 to 30 September 2024
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).
Time frame: 15 May 2024 to 30 September 2024
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.
Time frame: 15 May 2024 to 30 September 2024
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.
Time frame: 15 May 2024 to 30 September 2024
Plan to share: No — Individual participant data will be available from the corresponding authors of study publications upon reasonable request.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universitätsklinikum Hamburg-Eppendorf →