Study Stopped
Terminated due to an unusually cold and rainy summer. E.g. in Hamburg the average temperature between 16 July and 15 August 2023 was below 17°C. Collected data will be used to pilot study design and questionnaire. We plan to repeat the study in 2024.
Chronical Illness-related Limitations of the Ability to Cope With Rising Temperatures: an Observational Study
CLIMATE
1 other identifier
observational
61
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2023
CompletedStudy Start
First participant enrolled
July 24, 2023
CompletedFirst Posted
Study publicly available on registry
July 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 3, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 3, 2023
CompletedSeptember 13, 2023
September 1, 2023
1 month
July 17, 2023
September 8, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Self-rated health
Once per week between 29 July - 27 October 2023
Use of medical services
Once per week between 29 July - 27 October 2023
Reasons for drop out (eg, bad health condition, hospital admission, death)
Once after 27 October 2023
Eligibility Criteria
The study is located in different sites in Germany. Patients from approximately 50 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 twelve subsequent assessments of symptoms by email. The investigators estimated that approximately 1500 patients will be contacted. From experience with similar studies the investigators anticipated a response rate of 40% (=600 patients).
You may qualify if:
- 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).
You may not qualify if:
- no capacity to consent
- severe visual impairment
- insufficient German language skills
- not able to use internet browser (eg, lack of hardware)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Related Publications (1)
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.
PMID: 39496153DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ingmar Schäfer, PD Dr.
Universitätsklinikum Hamburg-Eppendorf
- PRINCIPAL INVESTIGATOR
Martin Scherer, Prof. Dr.
Universitätsklinikum Hamburg-Eppendorf
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2023
First Posted
July 27, 2023
Study Start
July 24, 2023
Primary Completion
September 3, 2023
Study Completion
September 3, 2023
Last Updated
September 13, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share
IPD will be available from the corresponding authors of study publications upon reasonable request.