Chronical Illness-related Limitations of the Ability to Cope With Rising Temperatures: an Observational Study (CLIMATE)

September 8, 2023 updated by: Universitätsklinikum Hamburg-Eppendorf

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Hamburg, Germany
        • Universitätsklinikum Hamburg-Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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).

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • no capacity to consent
  • severe visual impairment
  • insufficient German language skills
  • not able to use internet browser (eg, lack of hardware)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Once per week between 29 July - 27 October 2023

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-rated health
Time Frame: Once per week between 29 July - 27 October 2023
Measured by visual analogue scale
Once per week between 29 July - 27 October 2023
Use of medical services
Time Frame: Once per week between 29 July - 27 October 2023
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)
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
We will ask participants at baseline for permission to contact any confidential contact in case they drop out from the study
Once after 27 October 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitätsklinikum Hamburg-Eppendorf

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ingmar Schäfer, PD Dr., Universitätsklinikum Hamburg-Eppendorf
  • Principal Investigator: Martin Scherer, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 24, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 3, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 3, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IPA-2023-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will be available from the corresponding authors of study publications upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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