Effects of Integrative Medicine on Infectious Respiratory Diseases Including COVID-19 (AtemNHK)

September 28, 2022 updated by: Andreas Michalsen, Charite University, Berlin, Germany

Effects of Interventions and Lifestyle Modifications in Integrative Medicine and the Course of Infectious Respiratory Diseases Including COVID-19

The outbreak of the novel coronavirus SARS-CoV-2 caused a health emergency of international proportions when it was declared by the World Health Organization (WHO) in January 2020. Since then, the virus has spread internationally and the WHO has classified the outbreak as a pandemic. In the context of the increasing reporting of this pandemic and the increasing governmental measures to limit or slow down the spread of SARS-CoV-2 by all means, there is so far little scientific evidence for the effects of a healthy lifestyle on the disease. The aim of this study is to compare the potential of different, possibly protective lifestyles using the example of the COVID-19 pandemic. We will conduct an online survey with 3.000 participants using mobile website technology.

Study Overview

Status

Status

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

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.
1287

Contacts and Locations

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

Study Locations

  • Germany
      • Berlin, Germany, 14169
        • Charite University

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

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study is advertised via a website, thus all interested people can participate in this survey.

Description

Inclusion Criteria:

- Present declaration of consent

Exclusion Criteria:

- Lack of consent to participate in the study

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

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Online survey with 3.000 participants using mobile website technology
Other: Cross-sectional survey
No intervention.

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
Time Frame
SARS-CoV-2 infection
Time Frame: Assessed retrospectively (last 6 months) with self-designed question
Assessed retrospectively (last 6 months) with self-designed question

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
Influenza virus infection
Time Frame: Assessed retrospectively (last 6 months) with self-designed question
Assessed retrospectively (last 6 months) with self-designed question
Other respiratory infections
Time Frame: Assessed retrospectively (last 6 months) with self-designed question
Assessed retrospectively (last 6 months) with self-designed question
Dietary habits
Time Frame: Assessed retrospectively (last 6 months) with self-designed question
Assessed retrospectively (last 6 months) with self-designed question
Sports activity
Time Frame: Assessed retrospectively (last 6 months) with self-designed question
Assessed retrospectively (last 6 months) with self-designed question
Time spent in nature
Time Frame: Assessed retrospectively (last 6 months) with self-designed question
Assessed retrospectively (last 6 months) with self-designed question
Use of hydrotherapy/Kneipp applications
Time Frame: Assessed retrospectively (last 6 months) with self-designed question
Assessed retrospectively (last 6 months) with self-designed question
Use of anthroposophic medicine
Time Frame: Assessed retrospectively (last 6 months) with self-designed question
Assessed retrospectively (last 6 months) with self-designed question
Use of digital health services
Time Frame: Assessed retrospectively (last 6 months) with self-designed question
Assessed retrospectively (last 6 months) with self-designed question
Use of phytotherapy
Time Frame: Assessed retrospectively (last 6 months) with self-designed question
Assessed retrospectively (last 6 months) with self-designed question
Use of dietary supplements
Time Frame: Assessed retrospectively (last 6 months) with self-designed question
Assessed retrospectively (last 6 months) with self-designed question
WHO-5 Well-Being Index
Time Frame: Assessed when filling out the questionnaire (Baseline)
The scale ranges from 0 to 100, where 0 is the lowest level of well-being / lowest quality of life and 100 is the highest level of well-being / highest quality of life.
Assessed when filling out the questionnaire (Baseline)
Numeric analog scale (NAS) stress
Time Frame: Assessed retrospectively (last 6 months) with self-designed question
The NAS ranges from 0 to 10, where 0 is the lowest level of stress and 10 is the highest level of stress.
Assessed retrospectively (last 6 months) with self-designed question
Numeric analog scale (NAS) anxiety
Time Frame: Assessed retrospectively (last 6 months) with self-designed question
The NAS ranges from 0 to 10, where 0 is the lowest level of anxiety and 10 is the highest level of anxiety.
Assessed retrospectively (last 6 months) with self-designed question
Numeric analog scale (NAS) depression
Time Frame: Assessed retrospectively (last 6 months) with self-designed question
The NAS ranges from 0 to 10, where 0 is the lowest level of anxiety and 10 is the highest level of anxiety.
Assessed retrospectively (last 6 months) with self-designed question
Use of relaxation / mind body approaches
Time Frame: Assessed retrospectively (last 6 months) with self-designed question
Assessed retrospectively (last 6 months) with self-designed question
Alcohol consumption
Time Frame: Assessed retrospectively (last 6 months) with self-designed question
Assessed retrospectively (last 6 months) with self-designed question
Cigarette consumption
Time Frame: Assessed retrospectively (last 6 months) with self-designed question
Assessed retrospectively (last 6 months) with self-designed question
Self-efficacy
Time Frame: Assessed when filling out the questionnaire (Baseline)
The scale ranges from 0 to 100, where 0 is the lowest level of self-efficacy and 100 is the highest level of self-efficacy.
Assessed when filling out the questionnaire (Baseline)
Sick leave
Time Frame: Assessed retrospectively (last 6 months) with self-designed question
Assessed retrospectively (last 6 months) with self-designed question

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Qualitative interviews
Time Frame: Conducted 1 month after completion of the questionnaire (once)
Conducted 1 month after completion of the questionnaire (once)

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.
Charite University, Berlin, Germany

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.
January 6, 2021

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.
March 5, 2021

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.
March 5, 2021

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).
November 23, 2020

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.
November 27, 2020

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.
December 4, 2020

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 29, 2022

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 28, 2022

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, 2022

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.
  • AtemNHK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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