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

• Sponsor: Charite University, Berlin, Germany (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04653727
• Collaborator: (none)
• Enrollment: 1,287
• Location: 1
• Anticipated Duration (Months): 10.8
• Patients Per Site Per Month: 119.1

Study Details

Study Description

Brief 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. 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.

Condition or Disease	Intervention/Treatment	Phase
Covid19; Influenza A; Respiratory Disease	Other: Cross-sectional survey

Study Design

• Study Type: Observational
• Actual Enrollment: 1287 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Effects of Interventions and Lifestyle Modifications in Integrative Medicine and the Course of Infectious Respiratory Diseases Including COVID-19
• Actual Study Start Date: Jan 6, 2021
• Actual Primary Completion Date: Mar 6, 2021
• Anticipated Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Online survey with 3.000 participants using mobile website technology	Other: Cross-sectional survey; No intervention.

Outcome Measures

Primary Outcome Measures

1. SARS-CoV-2 infection [Assessed retrospectively (last 6 months) with self-designed question]

Secondary Outcome Measures

1. Influenza virus infection [Assessed retrospectively (last 6 months) with self-designed question]

2. Other respiratory infections [Assessed retrospectively (last 6 months) with self-designed question]

3. Dietary habits [Assessed retrospectively (last 6 months) with self-designed question]

4. Sports activity [Assessed retrospectively (last 6 months) with self-designed question]

5. Time spent in nature [Assessed retrospectively (last 6 months) with self-designed question]

6. Use of hydrotherapy/Kneipp applications [Assessed retrospectively (last 6 months) with self-designed question]

7. Use of anthroposophic medicine [Assessed retrospectively (last 6 months) with self-designed question]

8. Use of digital health services [Assessed retrospectively (last 6 months) with self-designed question]

9. Use of phytotherapy [Assessed retrospectively (last 6 months) with self-designed question]

10. Use of dietary supplements [Assessed retrospectively (last 6 months) with self-designed question]

11. WHO-5 Well-Being Index [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.

12. Numeric analog scale (NAS) stress [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.

13. Numeric analog scale (NAS) anxiety [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.

14. Numeric analog scale (NAS) depression [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.

15. Use of relaxation / mind body approaches [Assessed retrospectively (last 6 months) with self-designed question]

16. Alcohol consumption [Assessed retrospectively (last 6 months) with self-designed question]

17. Cigarette consumption [Assessed retrospectively (last 6 months) with self-designed question]

18. Self-efficacy [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.

19. Sick leave [Assessed retrospectively (last 6 months) with self-designed question]

Other Outcome Measures

1. Qualitative interviews [Conducted 1 month after completion of the questionnaire (once)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Present declaration of consent

Exclusion Criteria:

• Lack of consent to participate in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charite University	Berlin		Germany	14169

Sponsors and Collaborators

• Charite University, Berlin, Germany

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Andreas Michalsen, PI, Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT04653727
• Other Study ID Numbers: AtemNHK
• First Posted: Dec 4, 2020
• Last Update Posted: Jul 29, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Respiration Disorders; Respiratory Tract Diseases

Study Results

No Results Posted as of Jul 29, 2021