Covid19AtemNHKNCT04653727
Effects of Integrative Medicine on Infectious Respiratory Diseases Including COVID-19
An observational study of Covid19 and Influenza A, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, Influenza A, Respiratory Disease
- What is being tested?
- Cross-sectional survey
- How many people
- 1,287 participants
- Where
- 1 siteGermany
- Study dates
- 6 Jan 2021to 5 Mar 2021
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study is advertised via a website, thus all interested people can participate in this survey.
Who may be able to join
- Present declaration of consent
Who cannot join
- Lack of consent to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Covid19, Influenza A, Respiratory Disease
- Being tested
- Cross-sectional survey
- Medical subject headings
- COVID-19, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross-sectional surveyOther
No intervention.
| Study group | Role | What they receive |
|---|---|---|
| Online survey with 3.000 participants using mobile website technology | Not described Receives: Other: Cross-sectional survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
SARS-CoV-2 infection
Measured: Assessed retrospectively (last 6 months) with self-designed question
Secondary outcomes (19)
Influenza virus infection
Measured: Assessed retrospectively (last 6 months) with self-designed question
Other respiratory infections
Measured: Assessed retrospectively (last 6 months) with self-designed question
Dietary habits
Measured: Assessed retrospectively (last 6 months) with self-designed question
Sports activity
Measured: Assessed retrospectively (last 6 months) with self-designed question
Time spent in nature
Measured: Assessed retrospectively (last 6 months) with self-designed question
Use of hydrotherapy/Kneipp applications
Measured: Assessed retrospectively (last 6 months) with self-designed question
Use of anthroposophic medicine
Measured: Assessed retrospectively (last 6 months) with self-designed question
Use of digital health services
Measured: Assessed retrospectively (last 6 months) with self-designed question
Use of phytotherapy
Measured: Assessed retrospectively (last 6 months) with self-designed question
Use of dietary supplements
Measured: Assessed retrospectively (last 6 months) with self-designed question
WHO-5 Well-Being Index
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.
Measured: Assessed when filling out the questionnaire (Baseline)
Numeric analog scale (NAS) stress
The NAS ranges from 0 to 10, where 0 is the lowest level of stress and 10 is the highest level of stress.
Measured: Assessed retrospectively (last 6 months) with self-designed question
Numeric analog scale (NAS) anxiety
The NAS ranges from 0 to 10, where 0 is the lowest level of anxiety and 10 is the highest level of anxiety.
Measured: Assessed retrospectively (last 6 months) with self-designed question
Numeric analog scale (NAS) depression
The NAS ranges from 0 to 10, where 0 is the lowest level of anxiety and 10 is the highest level of anxiety.
Measured: Assessed retrospectively (last 6 months) with self-designed question
Use of relaxation / mind body approaches
Measured: Assessed retrospectively (last 6 months) with self-designed question
Alcohol consumption
Measured: Assessed retrospectively (last 6 months) with self-designed question
Cigarette consumption
Measured: Assessed retrospectively (last 6 months) with self-designed question
Self-efficacy
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.
Measured: Assessed when filling out the questionnaire (Baseline)
Sick leave
Measured: Assessed retrospectively (last 6 months) with self-designed question
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start6 Jan 2021
- Primary completion5 Mar 2021
- Study completion5 Mar 2021
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 Covid19Studies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653727
- Sponsor's protocol ID
- AtemNHK
- Acronym
- AtemNHK
- Status last verified
- Sep 2022
- First submitted
- 23 Nov 2020
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jeitler M, Erehman A, Koppold DA, Ortiz M, Jerzynski L, Stockigt B, Rotter G, Blakeslee S, Brinkhaus B, Michalsen A, Seifert G, Cramer H, Kandil FI, Kessler CS. Self-care and lifestyle interventions of complementary and integrative medicine during the COVID-19 pandemic-A cross-sectional study. Front Med (Lausanne). 2023 Jan 9;9:1033181. doi: 10.3389/fmed.2022.1033181. eCollection 2022.
PubMed 36698795
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Interventions and Lifestyle Modifications in Integrative Medicine and the Course of Infectious Respiratory Diseases Including COVID-19
- ClinicalTrials.gov ID
- NCT04653727
- Acronym / sponsor ID
- AtemNHK / AtemNHK
- Conditions
- Covid19, Influenza A, Respiratory Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,287 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 6 Jan 2021 (actual)
- Primary completion
- 5 Mar 2021 (actual)
- Study completion
- 5 Mar 2021 (actual)
- First posted
- 4 Dec 2020 (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 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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Online survey with 3.000 participants using mobile website technology | – | Other: Cross-sectional survey |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study is advertised via a website, thus all interested people can participate in this survey.
Key inclusion criteria (1 listed)
- Present declaration of consent
Key exclusion criteria (1 listed)
- Lack of consent to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cross-sectional surveyNo intervention. | Other | Online survey with 3.000 participants using mobile website technology |
Primary outcome
SARS-CoV-2 infection
Time frame: Assessed retrospectively (last 6 months) with self-designed question
19 secondary outcomes
Influenza virus infection
Time frame: Assessed retrospectively (last 6 months) with self-designed question
Other respiratory infections
Time frame: Assessed retrospectively (last 6 months) with self-designed question
Dietary habits
Time frame: Assessed retrospectively (last 6 months) with self-designed question
Sports activity
Time frame: Assessed retrospectively (last 6 months) with self-designed question
Time spent in nature
Time frame: 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
Use of anthroposophic medicine
Time frame: 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
Use of phytotherapy
Time frame: Assessed retrospectively (last 6 months) with self-designed question
Use of dietary supplements
Time frame: Assessed retrospectively (last 6 months) with self-designed question
WHO-5 Well-Being Index
Time frame: Assessed when filling out the questionnaire (Baseline)
Numeric analog scale (NAS) stress
Time frame: 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
Numeric analog scale (NAS) depression
Time frame: 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
Alcohol consumption
Time frame: Assessed retrospectively (last 6 months) with self-designed question
Cigarette consumption
Time frame: Assessed retrospectively (last 6 months) with self-designed question
Self-efficacy
Time frame: Assessed when filling out the questionnaire (Baseline)
Sick leave
Time frame: Assessed retrospectively (last 6 months) with self-designed question
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Derived from this study: PubMed 36698795Jeitler M, Erehman A, Koppold DA, Ortiz M, Jerzynski L, Stockigt B, Rotter G, Blakeslee S, Brinkhaus B, Michalsen A, Seifert G, Cramer H, Kandil FI, Kessler CS. Self-care and lifestyle interventions of complementary and integrative medicine during the COVID-19 pandemic-A cross-sectional study. Front Med (Lausanne). 2023 Jan 9;9:1033181. doi: 10.3389/fmed.2022.1033181. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Covid19 and Influenza A, run by Charite University, Berlin, Germany 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Sep 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
SARS-CoV-2 infection (time frame: Assessed retrospectively (last 6 months) with self-designed question). 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 NCT04653727, 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 29 Sep 2022.