Coronary DiseaseCLIMATENCT05961163
Chronical Illness-related Limitations of the Ability to Cope With Rising Temperatures: an Observational Study
An observational study of Coronary Disease and Myocardial Infarction, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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… 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
- 61 participants
- Where
- 1 siteGermany
- Study dates
- 24 Jul 2023to 3 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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. 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).
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 (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).
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 (CLIMATE)
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.
Read the 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
- Medical subject headings
- Coronary Disease, Myocardial Infarction, Heart Failure, Arrhythmias, Cardiac, Peripheral Arterial Disease, Stroke, Ischemic Attack, Transient, Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Once per week between 29 July - 27 October 2023
Secondary outcomes (3)
Self-rated health
Measured by visual analogue scale
Measured: Once per week between 29 July - 27 October 2023
Use of medical services
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)
Measured: Once per week between 29 July - 27 October 2023
Reasons for drop out (eg, bad health condition, hospital admission, death)
We will ask participants at baseline for permission to contact any confidential contact in case they drop out from the study
Measured: Once after 27 October 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start24 Jul 2023
- Primary completion3 Sep 2023
- Study completion3 Sep 2023
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ingmar Schäfer, PD Dr., Principal investigator, Universitätsklinikum Hamburg-EppendorfMartin Scherer, Prof. Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961163
- Sponsor's protocol ID
- IPA-2023-01
- Acronym
- CLIMATE
- Status last verified
- Sep 2023
- First submitted
- 17 Jul 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be available from the corresponding authors of study publications upon reasonable request.
Publications
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.
PubMed 39496153
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronical Illness-related Limitations of the Ability to Cope With Rising Temperatures: an Observational Study (CLIMATE)
- ClinicalTrials.gov ID
- NCT05961163
- Acronym / sponsor ID
- CLIMATE / IPA-2023-01
- Conditions
- Coronary Disease, Myocardial Infarction, Heart Failure, Arrhythmias, Cardiac, Peripheral Artery Disease, Stroke
- Study type
- Observational
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 3 Sep 2023 (actual)
- Study completion
- 3 Sep 2023 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (4 listed)
- no capacity to consent
- severe visual impairment
- insufficient German language skills
- not able to use internet browser (eg, lack of hardware)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 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.
3 secondary outcomes
Self-rated health
Time frame: Once per week between 29 July - 27 October 2023
Use of medical services
Time frame: Once per week between 29 July - 27 October 2023
Reasons for drop out (eg, bad health condition, hospital admission, death)
Time frame: Once after 27 October 2023
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Derived from this study: PubMed 39496153Jordan 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.
- Individual participant dataSharing planned: No. IPD will be available from the corresponding authors of study publications upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingmar Schäfer, PD Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
Martin Scherer, Prof. Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease and Myocardial Infarction, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Once per week between 29 July - 27 October 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05961163, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.