Coronary DiseaseCLIMATE-IIINCT06890208
Chronical Illness-related Limitations of the Ability to Cope With Rising Temperatures, Third Wave
An observational study of Coronary Disease and Myocardial Infarction, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
The CLIMATE-III 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, and the degree of urbanisation of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease, Myocardial Infarction, Heart Failure
- How many people
- 176 participants
- Where
- 1 siteGermany
- Study dates
- 11 Jun 2025to 12 Sep 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study is located in different sites in Germany and Italy. Patients from approximately 30 GP practices will be included (15 GP practices in Germany and 15 GP practices in Italy). 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 1,200 patients will be contacted. From experience with similar studies the investigators anticipated a response rate of 20% (=240 patients).
Who may be able to join
- 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.
Who cannot join
- no capacity to consent
- severe visual impairment
- insufficient German language skills
- not able to use internet browser (eg, lack of hardware)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronical Illness-related Limitations of the Ability to Cope With Rising Temperatures: an Observational Study in Germany and Italy, Third Wave (CLIMATE-III)
The CLIMATE-III 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, and the degree of urbanisation of the patients' administration district are associated with these effects. Study participants from Germany and Italy will be included in the sample.
Read the detailed description
The CLIMATE-III 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 general practitioner (GP) practices in Germany and Italy. 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 Monday. 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 Thursday 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, somatosensory amplification, perceived risk for adverse health effects of heat, intention to implement protective behaviour, perceived benefit of this behavior, self-efficacy, and health literacy. Local data on temperatures and humidity will be provided by the meteorological services of Germany and Italy. 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
- Being tested
- No intervention
- Medical subject headings
- Coronary Disease, Myocardial Infarction, Heart Failure, Arrhythmias, Cardiac, Peripheral Arterial Disease, Stroke, Ischemic Attack, Transient, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 May 2025 to 30 September 2025
Secondary outcomes (3)
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 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.
Measured: 15 May 2025 to 30 September 2025
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).
Measured: 15 May 2025 to 30 September 2025
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.
Measured: 15 May 2025 to 30 September 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start11 Jun 2025
- Primary completion12 Sep 2025
- Study completion12 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Claudiana Landesfachhochschule
- Responsible party
- Sponsor
- Investigators
- Ingmar Schäfer, PD Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890208
- Sponsor's protocol ID
- LPEK-0887
- Acronym
- CLIMATE-III
- Status last verified
- May 2026
- First submitted
- 16 Mar 2025
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided