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

Not Applicable

Recruiting

• Conditions: Post-COVID Syndrome
• Interventions: Behavioral: Complementary and Integrative Medicine online intervention, routine care and book; Behavioral: Routine care and book

• Registration Number: NCT06004362
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-17
• Study First Submitted QC: 2023-08-21
• Study First Posted: 2023-08-22
• Study Start: 2023-09-04
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Complementary and Integrative Medicine online intervention, routine care and book	Complementary and Integrative Medicine online intervention, routine care and book	-
Routine care and book	Routine care and book	-

Primary Outcome Measures

Name	Time	Method
Short Form 36 (SF-36), Physical Functioning Scale	Baseline, 10 weeks	The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.

Secondary Outcome Measures

Name	Time	Method
Expectation regarding study intervention	Baseline	5-point likert-scale. The scale ranges from 0 to 5, where 0 is the lowest level and 5 is the highest level.
DePaul Post-Exertional Malaise Questionnaire (DSQ-PEM)	Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks	The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Chalder Fatigue Scale (CFS)	Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks	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)	Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Quality of life (EQ-5D-5L)	Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks	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	Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks	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	Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks	The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Continuation of the intervention	10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks	Asking Minutes (min.) of the last month
General Self-Efficacy Scale (GSE, German version: ASKU)	Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks	The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Safety by recording adverse events	Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Adherence to the study intervention	Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10	Asking Minutes (min.) of the last week
Short Form 36 (SF-36)	Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks	The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Visual analog scale (VAS) headache	Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks	The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Patient Health Questionnaire 9 (PHQ9)	Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks	The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Pittsburgh Sleep Quality Index (PSQI)	Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks	The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Post-COVID-Syndrom (PCS) Score	Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks	The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Perceived Stress Scale (PSS 4)	Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks	The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Satisfaction with the intervention	Week 10	5-point likert-scale. The scale ranges from 0 to 5, where 0 is the lowest level and 5 is the highest level.
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

Trial Locations

Locations (1)

Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus; 🇩🇪 Berlin, Germany