Clinical trial NCT06004362: 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
Overall status: RECRUITING
Phase: NA
Conditions: Post-COVID Syndrome
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Short Form 36 (SF-36), Physical Functioning Scale
timeFrame: Baseline, 10 weeks
Secondary outcomes:
measure: Short Form 36 (SF-36)
timeFrame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
measure: DePaul Post-Exertional Malaise Questionnaire (DSQ-PEM)
timeFrame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
measure: Post-COVID-Syndrom (PCS) Score
timeFrame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
measure: Chalder Fatigue Scale (CFS)
timeFrame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
measure: Quality of life (EQ-5D-5L)
timeFrame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
measure: General Self-Efficacy Scale (GSE, German version: ASKU)
timeFrame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
measure: Visual analog scale (VAS) physical strength
timeFrame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
measure: Visual analog scale (VAS) mental strength
timeFrame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
measure: Visual analog scale (VAS) headache
timeFrame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
measure: Patient Health Questionnaire 9 (PHQ9)
timeFrame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
measure: Lifestyle questions (diet, alcohol, cigarettes, relaxation, hydrotherapie, nature stays, physical activity)
timeFrame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
measure: Expectation regarding study intervention
timeFrame: Baseline
measure: Perceived Stress Scale (PSS 4)
timeFrame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
measure: Satisfaction with the intervention
timeFrame: Week 10
measure: Safety by recording adverse events
timeFrame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
measure: Adherence to the study intervention
timeFrame: Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10
measure: Online diaries for assessing routine care (GP prescriptions/measures, especially medication and phytotherapy/nutritional supplements)
timeFrame: 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
measure: Continuation of the intervention
timeFrame: 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Other outcomes:
measure: Qualitative data
timeFrame: Week 10
measure: Sub-study: Focus group interviews with physicians
timeFrame: Week 10
measure: Sub-study: biosignal characteristics
timeFrame: Baseline, week 10
Locations:
city: Berlin
country: Germany
facility: Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
Study officials:
References: