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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Complementary and Integrative Medicine online intervention, routine care and book | Experimental |
| |
| Routine care and book | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Complementary and Integrative Medicine online intervention, routine care and book | Behavioral | 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:
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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Short Form 36 (SF-36) | The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level. | Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks |
| DePaul Post-Exertional Malaise Questionnaire (DSQ-PEM) |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative data | 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). | Week 10 |
Inclusion criteria:
Exclusion criteria:
Inclusion and exclusion criteria of the sub-study focus group interviews with physicians
Inclusion criteria:
Exclusion criteria:
• No previous care of post-covid patients
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miriam Rösner | Contact | 004980505682 | naturheilkunde.studien@immanuel.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus | Recruiting | Berlin | 14109 | Germany |
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| Routine care and book | Behavioral | 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. |
|
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
| Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks |
| Post-COVID-Syndrom (PCS) Score | The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level. | Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks |
| Chalder Fatigue Scale (CFS) | The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level. | Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks |
| 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. | Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks |
| 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. | Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks |
| 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. | Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks |
| 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. | Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks |
| Visual analog scale (VAS) headache | The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level. | Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks |
| Patient Health Questionnaire 9 (PHQ9) | The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level. | Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks |
| Pittsburgh Sleep Quality Index (PSQI) | The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level. | Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks |
| Lifestyle questions (diet, alcohol, cigarettes, relaxation, hydrotherapie, nature stays, physical activity) | Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks |
| 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. | Baseline |
| Perceived Stress Scale (PSS 4) | The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level. | Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks |
| 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. | Week 10 |
| Safety by recording adverse events | Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks |
| Adherence to the study intervention | Asking Minutes (min.) of the last week | Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10 |
| Online diaries for assessing routine care (GP prescriptions/measures, especially medication and phytotherapy/nutritional supplements) | Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 20, week 30, week 40, week 50 |
| Continuation of the intervention | Asking Minutes (min.) of the last month | 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks |
| Sub-study: Focus group interviews with physicians | 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. | Week 10 |
| Sub-study: biosignal characteristics | 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. | Baseline, week 10 |