Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-29 @ 2:49 PM
Study NCT ID:
NCT06890208
Status:
RECRUITING
Last Update Posted:
2025-06-29
First Post:
2025-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronical Illness-related Limitations of the Ability to Cope With Rising Temperatures, Third Wave
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002546', 'term': 'Ischemic Attack, Transient'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D001249', 'term': 'Asthma'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2025-03-16', 'studyFirstSubmitQcDate': '2025-03-16', 'lastUpdatePostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Summary score of severity of adverse health effects', 'timeFrame': '15 May 2025 to 30 September 2025', 'description': '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.'}], 'secondaryOutcomes': [{'measure': "Summary score of participants' implementation of protective behavior against heat", 'timeFrame': '15 May 2025 to 30 September 2025', 'description': '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.'}, {'measure': 'Self-rated health', 'timeFrame': '15 May 2025 to 30 September 2025', 'description': 'Subjective health condition on the day of assessment rated by participant on a visual analogue scale between 0 (worst possible) and 100 (best possible).'}, {'measure': 'Level of medical service use', 'timeFrame': '15 May 2025 to 30 September 2025', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nBaseline 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being 18 years or older\n* 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.\n\nExclusion Criteria:\n\n* no capacity to consent\n* severe visual impairment\n* insufficient German language skills\n* not able to use internet browser (eg, lack of hardware)'}, 'identificationModule': {'nctId': 'NCT06890208', 'acronym': 'CLIMATE-III', 'briefTitle': 'Chronical Illness-related Limitations of the Ability to Cope With Rising Temperatures, Third Wave', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Chronical Illness-related Limitations of the Ability to Cope With Rising Temperatures: an Observational Study in Germany and Italy, Third Wave (CLIMATE-III)', 'orgStudyIdInfo': {'id': 'LPEK-0887'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No intervention', 'description': 'No intervention', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['No intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Valentina Paucke', 'role': 'CONTACT', 'email': 'climate@uke.de'}], 'facility': 'University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'centralContacts': [{'name': 'Valentina Paucke', 'role': 'CONTACT', 'email': 'va.paucke@uke.de', 'phone': '+49-7410-53292'}], 'overallOfficials': [{'name': 'Ingmar Schäfer, PD Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Hamburg-Eppendorf'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'collaborators': [{'name': 'Claudiana Landesfachhochschule', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}