- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04653727
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
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
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
-
-
-
Berlin, Germany, 14169
- Charité 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
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 |
Intervention / Treatment |
---|---|
Online survey with 3.000 participants using mobile website technology
|
No intervention.
|
What is the study measuring?
Primary Outcome Measures
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
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
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.
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)
January 6, 2021
Primary Completion (Actual)
March 5, 2021
Study Completion (Actual)
March 5, 2021
Study Registration Dates
First Submitted
November 23, 2020
First Submitted That Met QC Criteria
November 27, 2020
First Posted (Actual)
December 4, 2020
Study Record Updates
Last Update Posted (Actual)
September 29, 2022
Last Update Submitted That Met QC Criteria
September 28, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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