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Complementary and Integrative Medicine as an Online Intervention in Patients With Post-covid Syndrome After COVID-19

Primary Purpose

Post-COVID Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Complementary and Integrative Medicine online intervention, routine care and book
Routine care and book
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-COVID Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Acute SARS-CoV2 infection at least 12 weeks ago (documented by PCR test results or SARS-CoV-2 antibodies) History of chronic fatigue (after SARS-CoV-2 infection) At least 3 of 7 criteria fulfilled at the time of inclusion: sleep disturbance, headache, joint pain/muscle pain, anxiety/depression, memory impairment/concentration disturbance, postexertional malaise, dysosmia/anosmia Numerical Rating Scale (NRS, 0-10 points, 0 = not able to exercise at all; 10 = full exercise capacity) physical exercise capacity of max. 6 points ("What is your physical exercise capacity on average over the last 7 days?") Short Form-36 Physical Function Subscale (SF-36 PFS) of maximum 65 points Patient are technically equipped enough to participate in the online intervention and willing to follow the study procedure to perform the online intervention at home Exclusion criteria: Fatigue already present before SARS-CoV-2 infection Presence of severe post-exertional malaise (PEM) (according to DSQ-PEM tool question 7 OR 8 with yes AND >14h condition worsening) Other underlying conditions leading to symptoms of chronic fatigue, such as unstable mental illness, oncological disease(s), MS, fibromyalgia, and substance abuse Other serious underlying medical conditions, such as severe pulmonary, cardiac, psychiatric, or infectious diseases that could interfere with study participation or affect results • Ongoing opioid therapy or opioid therapy in the week prior to study entry Regular use of cannabinoids or other illicit drugs in the month prior to or during the study Restarting or discontinuing psychotherapy during study participation in the 6 weeks prior to study entry Pregnancy or breastfeeding Participation in another clinical intervention study during study participation 1 Regular use of Complementary and Integrative Medicine self-help measures (e.g. meditation, Kneipp hydrotherapiy, etc.) within the study period Current pension procedure or planned claiming of a pension procedure due to disability Planned rehabilitation measures during study participation due to post-COVID syndrome Inclusion and exclusion criteria of the sub-study focus group interviews with physicians Inclusion criteria: Family physicians and general practitioners Regular outpatient care of patients with post-covid syndrome Willingness in principle to participate in a 2-hour interview on-site or online Exclusion criteria: • No previous care of post-covid patients

Sites / Locations

  • Charité Hochschulambulanz für Naturheilkunde am Immanuel KrankenhausRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Complementary and Integrative Medicine online intervention, routine care and book

Routine care and book

Arm Description

Outcomes

Primary Outcome Measures

Short Form 36 (SF-36), Physical Functioning Scale
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.

Secondary Outcome Measures

Short Form 36 (SF-36)
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
DePaul Post-Exertional Malaise Questionnaire (DSQ-PEM)
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Post-COVID-Syndrom (PCS) Score
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Chalder Fatigue Scale (CFS)
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Quality of life (EQ-5D-5L)
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
General Self-Efficacy Scale (GSE, German version: ASKU)
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Visual analog scale (VAS) physical strength
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Visual analog scale (VAS) mental strength
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Visual analog scale (VAS) headache
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Patient Health Questionnaire 9 (PHQ9)
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Pittsburgh Sleep Quality Index (PSQI)
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Lifestyle questions (diet, alcohol, cigarettes, relaxation, hydrotherapie, nature stays, physical activity)
Expectation regarding study intervention
5-point likert-scale. The scale ranges from 0 to 5, where 0 is the lowest level and 5 is the highest level.
Perceived Stress Scale (PSS 4)
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Satisfaction with the intervention
5-point likert-scale. The scale ranges from 0 to 5, where 0 is the lowest level and 5 is the highest level.
Safety by recording adverse events
Adherence to the study intervention
Asking Minutes (min.) of the last week
Online diaries for assessing routine care (GP prescriptions/measures, especially medication and phytotherapy/nutritional supplements)
Continuation of the intervention
Asking Minutes (min.) of the last month

Full Information

First Posted
August 17, 2023
Last Updated
September 4, 2023
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT06004362
Brief Title
Complementary and Integrative Medicine as an Online Intervention in Patients With Post-covid Syndrome After COVID-19
Official Title
Complementary and Integrative Medicine as an Online Intervention in Patients With Post-covid Syndrome - a Randomized-controlled Mixed-methods Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 4, 2023 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The Post-COVID syndrome is a COVID-19 sequelae disease with high individual burden. We conduct a prospective, two-arm, randomized-controlled intervention study with embedded qualitative and physiological sub-studies in a mixed-methods design.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-COVID Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Complementary and Integrative Medicine online intervention, routine care and book
Arm Type
Experimental
Arm Title
Routine care and book
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Complementary and Integrative Medicine online intervention, routine care and book
Intervention Description
The online program takes place in a multiprofessionally guided online group setting once a week for up to 180 minutes (including several breaks) over a period of 10 weeks: Basic principles of a plant-based whole-food nutrition Procedures of hydrotherapy according to Kneipp Self-help strategies (e.g. teas, wraps, compresses etc.) Methods of mind-body medicine (mindfulness, meditation, breathing, yoga etc.) Methods of extended Complementary and Integrative Medicine (e.g. acupressure) It is recommended to practice a part of the taught exercises at home for about 30 minutes daily. In addition, the patients receive a book for the treatment of post-covid syndrome complaints. Group 1 additionally uses the already existing routine care (e.g. general practitioner).
Intervention Type
Behavioral
Intervention Name(s)
Routine care and book
Intervention Description
Participants in the second study arm receive routine care, e.g. from their general practitioner. In addition, the patients receive the same book as group 1 for the treatment of post-covid syndrome complaints. The participants of the second study arm will be offered to participate in the Complementary and Integrative Medicine online intervention after 4 months within the study.
Primary Outcome Measure Information:
Title
Short Form 36 (SF-36), Physical Functioning Scale
Description
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Time Frame
Baseline, 10 weeks
Secondary Outcome Measure Information:
Title
Short Form 36 (SF-36)
Description
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Time Frame
Baseline, 10 weeks, 4 months, 6 months, 12 months
Title
DePaul Post-Exertional Malaise Questionnaire (DSQ-PEM)
Description
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Time Frame
Baseline, 10 weeks, 4 months, 6 months, 12 months
Title
Post-COVID-Syndrom (PCS) Score
Description
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Time Frame
Baseline, 10 weeks, 4 months, 6 months, 12 months
Title
Chalder Fatigue Scale (CFS)
Description
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Time Frame
Baseline, 10 weeks, 4 months, 6 months, 12 months
Title
Quality of life (EQ-5D-5L)
Description
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Time Frame
Baseline, 10 weeks, 4 months, 6 months, 12 months
Title
General Self-Efficacy Scale (GSE, German version: ASKU)
Description
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Time Frame
Baseline, 10 weeks, 4 months, 6 months, 12 months
Title
Visual analog scale (VAS) physical strength
Description
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Time Frame
Baseline, 10 weeks, 4 months, 6 months, 12 months
Title
Visual analog scale (VAS) mental strength
Description
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Time Frame
Baseline, 10 weeks, 4 months, 6 months, 12 months
Title
Visual analog scale (VAS) headache
Description
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Time Frame
Baseline, 10 weeks, 4 months, 6 months, 12 months
Title
Patient Health Questionnaire 9 (PHQ9)
Description
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Time Frame
Baseline, 10 weeks, 4 months, 6 months, 12 months
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Time Frame
Baseline, 10 weeks, 4 months, 6 months, 12 months
Title
Lifestyle questions (diet, alcohol, cigarettes, relaxation, hydrotherapie, nature stays, physical activity)
Time Frame
Baseline, 10 weeks, 4 months, 6 months, 12 months
Title
Expectation regarding study intervention
Description
5-point likert-scale. The scale ranges from 0 to 5, where 0 is the lowest level and 5 is the highest level.
Time Frame
Baseline
Title
Perceived Stress Scale (PSS 4)
Description
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Time Frame
Baseline, 10 weeks, 4 months, 6 months, 12 months
Title
Satisfaction with the intervention
Description
5-point likert-scale. The scale ranges from 0 to 5, where 0 is the lowest level and 5 is the highest level.
Time Frame
Week 10
Title
Safety by recording adverse events
Time Frame
Baseline, 10 weeks, 4 months, 6 months, 12 months
Title
Adherence to the study intervention
Description
Asking Minutes (min.) of the last week
Time Frame
Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10
Title
Online diaries for assessing routine care (GP prescriptions/measures, especially medication and phytotherapy/nutritional supplements)
Time Frame
Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, 4 months, 6 months, 12 months
Title
Continuation of the intervention
Description
Asking Minutes (min.) of the last month
Time Frame
4 months, 6 months, 12 months
Other Pre-specified Outcome Measures:
Title
Qualitative data
Description
After the end of the intervention, qualitative data will be collected at week 10 from a randomized subpopulation (n=15-20) for the purpose of evaluating the online intervention from the patient's perspective using semi-structured, guided interviews with narrative components (of interest, for example, are the subjective experiences, the experience of the disease and its effects).
Time Frame
Week 10
Title
Sub-study: Focus group interviews with physicians
Description
In a sub-study, focus group interviews will be conducted with n=7-10 primary care physicians in routine care. Depending on the research results, the number and structure of the interviews and the interviewed patients can be adapted according to the explorative requirements of the qualitative analysis. The interviews will be digitally recorded, pseudonymously transcribed and qualitatively analyzed.
Time Frame
Week 10
Title
Sub-study: biosignal characteristics
Description
In another subgroup (electrophysiological sub-study) with n=48 participants, multichannel electrophysiological measurements are performed in each case at baseline and week 10, in which heart rate, blood pressure, respiratory rate, pulse, electrodermal activity and brain activity (EEG) are recorded synchronously - by means of monitoring systems (SOMNOmedics, SOMNO HD EEG 32) and Corsano Smartwatch. Furthermore, hand force is measured in a standardized way.
Time Frame
Baseline, week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Acute SARS-CoV2 infection at least 12 weeks ago (documented by PCR test results or SARS-CoV-2 antibodies) History of chronic fatigue (after SARS-CoV-2 infection) At least 3 of 7 criteria fulfilled at the time of inclusion: sleep disturbance, headache, joint pain/muscle pain, anxiety/depression, memory impairment/concentration disturbance, postexertional malaise, dysosmia/anosmia Numerical Rating Scale (NRS, 0-10 points, 0 = not able to exercise at all; 10 = full exercise capacity) physical exercise capacity of max. 6 points ("What is your physical exercise capacity on average over the last 7 days?") Short Form-36 Physical Function Subscale (SF-36 PFS) of maximum 65 points Patient are technically equipped enough to participate in the online intervention and willing to follow the study procedure to perform the online intervention at home Exclusion criteria: Fatigue already present before SARS-CoV-2 infection Presence of severe post-exertional malaise (PEM) (according to DSQ-PEM tool question 7 OR 8 with yes AND >14h condition worsening) Other underlying conditions leading to symptoms of chronic fatigue, such as unstable mental illness, oncological disease(s), MS, fibromyalgia, and substance abuse Other serious underlying medical conditions, such as severe pulmonary, cardiac, psychiatric, or infectious diseases that could interfere with study participation or affect results • Ongoing opioid therapy or opioid therapy in the week prior to study entry Regular use of cannabinoids or other illicit drugs in the month prior to or during the study Restarting or discontinuing psychotherapy during study participation in the 6 weeks prior to study entry Pregnancy or breastfeeding Participation in another clinical intervention study during study participation 1 Regular use of Complementary and Integrative Medicine self-help measures (e.g. meditation, Kneipp hydrotherapiy, etc.) within the study period Current pension procedure or planned claiming of a pension procedure due to disability Planned rehabilitation measures during study participation due to post-COVID syndrome Inclusion and exclusion criteria of the sub-study focus group interviews with physicians Inclusion criteria: Family physicians and general practitioners Regular outpatient care of patients with post-covid syndrome Willingness in principle to participate in a 2-hour interview on-site or online Exclusion criteria: • No previous care of post-covid patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miriam Rösner
Phone
004980505682
Email
naturheilkunde.studien@immanuel.de
Facility Information:
Facility Name
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
City
Berlin
ZIP/Postal Code
14109
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miriam Rösner, Study nurse
Phone
00493080505682
Email
naturheilkunde.studien@immanuel.de
First Name & Middle Initial & Last Name & Degree
Andreas Michalsen, Prof. Dr.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Complementary and Integrative Medicine as an Online Intervention in Patients With Post-covid Syndrome After COVID-19

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