Back to resultsEvaluation of an Integrative Medicine Outpatient Clinical Setting for Post-COVID-19 Patients (TaPoCo)
Primary Purpose
COVID-19, Fatigue
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
outpatient clinic with multimodal integrative medicine and naturopathy for post-COVID-19 patients
waiting group
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Covid-19, fatigue, outpatient clinic, integrative naturopathy, integrative medicine
Eligibility Criteria
Inclusion Criteria: 18 to 75 years of age diagnosed with post covid syndrome fatigue with or without myalgia signed declaration of consent Exclusion Criteria: contraindications for whole body infrared hyperthermia (severe cardiovascular diseases, tumour diseases, acute infections, pregnant and breastfeeding women) Acute and or feverish microbially infections Pleuritic chest pain Relevant shortness of breath Zn Critical illness or intensive medical care because of COVID 19 Patients with severe somatic, cardiovascular pneumological, rheumatic, endocrine or neurological comorbidities. Especially neurological disorders accompanied by cognitive impairment, severe liver or kidney disorders. Patients permanently treated with opioids, cannabis, immunosuppressive agents (e.g. corticoids, immunsuppressives) or alpha/beta-a(nta)gonists Patients with pain as a consequence of a severe psychiatric disease (bipolar disorder, psychosis, personality disorder, severe depression, substance abuse) as well as severe systematic disorders or neurological disorders Participation in other clinical studies
Sites / Locations
- Sozialstiftung Bamberg, Klinik für Intergrative MedizinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Treatment group
Waiting group
Arm Description
The treatment group has 11 visits in the outpatient clinic of integrative medicine and naturopathy. Additional they fill in a diary and wear a pedometer during the day. Diary and pedometer continue to week 15. In week 12 a video conference with the treatment-group takes place. During week 14+15 a qualitative telephone interview is set. Patients fill in questionnaires before the start of the outpatient clinic and directly afterwards (week 11).
Parallel to the treatment group the waiting group receives no intervention, but fills in a diary and wear a pedometer during the day. Their diary and pedometer continue only to week 11. No additional interventions (refresher; video conference; interview) take place. Patients fill in questionnaires before the start of the waiting phase, parallel to the start of the outpatient clinic and directly after its end (week 11).
Outcomes
Primary Outcome Measures
Fatigue - Change from week 0 to week 11
measured with MFI-20 questionnaire and Chalder fatigue scale MFI-20: 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Higher total scores correspond with more acute levels of fatigue.
Chalder fatigue scale: a questionnaire to measure the severity of tiredness in fatiguing illnesses. The 11-item chalder fatigue scale is often divided into two components: one that measures physical fatigue (questions 1-7) and one that measures mental fatigue (questions 8-11).
Secondary Outcome Measures
Quality of life 1
SF-12: Short Form of the Health Survey Questionnaire is a 12-item, patient-reported survey of patient health. It is a reduced size version of the SF-36, and is widely used.
Hospital Anxiety and Depression
HADS: Hospital Anxiety and Depression Scale, 14 items (7 each for depressive symptoms or symptoms of anxiety). The two summated scores of the summated scales HADS-A and HADS-D range between 0 and 21. High scores indicate depressivness and anxiety.
Perceived Stress
PSS-10: Perceived Stress Scale, Rating on a five-step scale from 1 (= never) to 5 (=very often), high stress is assumed from a total score of 20 points
perceived Pain
BPI: Brief Pain Inventory, An inventory including 15 Items about the intensity of pain (4 items, numeric rating scales from 1 (no pain) to 10 (worst pain imaginable), pain impairment (7 items with NRS from 1-10) and the efficacy of medications/treatments. Higher scores indicate higher average pain/pain impairment.
Quality of life 2
EQ-5D: Quality of life EQ-5D is an instrument which evaluates the generic quality of life. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Sleep Quality
PSQI: Der Pittsburgh Sleep Quality Index It contains seven subscales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. All items refer to the last four weeks and are assessed either in four frequency levels or in an open-end format. A total sum score from 0 - 21 can be derived from the subscales with higher scores indicating higher sleep disturbance.
Resilience
BRS: Brief Resilience Scale Questionnaire A 6-item questionnaire to assess the perceived ability to bounce back or recover from stress. The possible score range on the BRS is from 1 (low resilience) to 5 (high resilience).
Full Information
NCT ID
NCT05630378
First Posted
August 26, 2022
Last Updated
April 19, 2023
Sponsor
Universität Duisburg-Essen
1. Study Identification
Unique Protocol Identification Number
NCT05630378
Brief Title
Evaluation of an Integrative Medicine Outpatient Clinical Setting for Post-COVID-19 Patients
Acronym
TaPoCo
Official Title
Evaluation of a Multimodal Integrative Medicine and Naturopathy Program in an Outpatient Clinical Setting With Focus on Mind-Body Medicine and Mild Water Filtered Infrared-A Whole-body Hyperthermia for Improvement of Symptoms and Quality of Life in Patients With Post-COVID-19-syndrome - a Prospective Randomised Controlled Study -
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study aims to identify whether a multimodal integrative naturopathy outpatient clinical concept can improve the symptoms of patients suffering from post-COVID-Syndrome. Main outcome is fatigue. The outpatient clinical programme consists of 11 weeks wherein patients visit the clinic one day per week. The pillars of classical naturopathy are combined with extended naturopathy and complementary procedures. Previous naturopathical studies on patients with chronic fatigue syndrome could find numerous indications that different types of naturopathy can help patients with fatigue.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Fatigue
Keywords
Covid-19, fatigue, outpatient clinic, integrative naturopathy, integrative medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel to the treatment group that visits the outpatient clinic on one day of the week for 11 weeks, the waiting group only fills in a diary and the questionnaires at two timepoints. Diary and questionnaires are the same for both groups.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
The treatment group has 11 visits in the outpatient clinic of integrative medicine and naturopathy. Additional they fill in a diary and wear a pedometer during the day. Diary and pedometer continue to week 15. In week 12 a video conference with the treatment-group takes place. During week 14+15 a qualitative telephone interview is set.
Patients fill in questionnaires before the start of the outpatient clinic and directly afterwards (week 11).
Arm Title
Waiting group
Arm Type
Other
Arm Description
Parallel to the treatment group the waiting group receives no intervention, but fills in a diary and wear a pedometer during the day. Their diary and pedometer continue only to week 11. No additional interventions (refresher; video conference; interview) take place. Patients fill in questionnaires before the start of the waiting phase, parallel to the start of the outpatient clinic and directly after its end (week 11).
Intervention Type
Behavioral
Intervention Name(s)
outpatient clinic with multimodal integrative medicine and naturopathy for post-COVID-19 patients
Intervention Description
Patients receive multimodal integrative medicine and naturopathy applications with focus on mind-body-medicine and whole body hyperthermia to reduce fatigue and improve quality of life.
Intervention Type
Other
Intervention Name(s)
waiting group
Intervention Description
Patients receive no intervention
Primary Outcome Measure Information:
Title
Fatigue - Change from week 0 to week 11
Description
measured with MFI-20 questionnaire and Chalder fatigue scale MFI-20: 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity. Higher total scores correspond with more acute levels of fatigue.
Chalder fatigue scale: a questionnaire to measure the severity of tiredness in fatiguing illnesses. The 11-item chalder fatigue scale is often divided into two components: one that measures physical fatigue (questions 1-7) and one that measures mental fatigue (questions 8-11).
Time Frame
before start of intervention (week 0) and afterwards (week 11)
Secondary Outcome Measure Information:
Title
Quality of life 1
Description
SF-12: Short Form of the Health Survey Questionnaire is a 12-item, patient-reported survey of patient health. It is a reduced size version of the SF-36, and is widely used.
Time Frame
before start of intervention (week 0) and afterwards (week 11)
Title
Hospital Anxiety and Depression
Description
HADS: Hospital Anxiety and Depression Scale, 14 items (7 each for depressive symptoms or symptoms of anxiety). The two summated scores of the summated scales HADS-A and HADS-D range between 0 and 21. High scores indicate depressivness and anxiety.
Time Frame
before start of intervention (week 0) and afterwards (week 11)
Title
Perceived Stress
Description
PSS-10: Perceived Stress Scale, Rating on a five-step scale from 1 (= never) to 5 (=very often), high stress is assumed from a total score of 20 points
Time Frame
before start of intervention (week 0) and afterwards (week 11)
Title
perceived Pain
Description
BPI: Brief Pain Inventory, An inventory including 15 Items about the intensity of pain (4 items, numeric rating scales from 1 (no pain) to 10 (worst pain imaginable), pain impairment (7 items with NRS from 1-10) and the efficacy of medications/treatments. Higher scores indicate higher average pain/pain impairment.
Time Frame
before start of intervention (week 0) and afterwards (week 11)
Title
Quality of life 2
Description
EQ-5D: Quality of life EQ-5D is an instrument which evaluates the generic quality of life. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Time Frame
before start of intervention (week 0) and afterwards (week 11)
Title
Sleep Quality
Description
PSQI: Der Pittsburgh Sleep Quality Index It contains seven subscales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. All items refer to the last four weeks and are assessed either in four frequency levels or in an open-end format. A total sum score from 0 - 21 can be derived from the subscales with higher scores indicating higher sleep disturbance.
Time Frame
before start of intervention (week 0) and afterwards (week 11)
Title
Resilience
Description
BRS: Brief Resilience Scale Questionnaire A 6-item questionnaire to assess the perceived ability to bounce back or recover from stress. The possible score range on the BRS is from 1 (low resilience) to 5 (high resilience).
Time Frame
before start of intervention (week 0) and afterwards (week 11)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 to 75 years of age
diagnosed with post covid syndrome
fatigue with or without myalgia
signed declaration of consent
Exclusion Criteria:
contraindications for whole body infrared hyperthermia (severe cardiovascular diseases, tumour diseases, acute infections, pregnant and breastfeeding women)
Acute and or feverish microbially infections
Pleuritic chest pain
Relevant shortness of breath
Zn Critical illness or intensive medical care because of COVID 19
Patients with severe somatic, cardiovascular pneumological, rheumatic, endocrine or neurological comorbidities. Especially neurological disorders accompanied by cognitive impairment, severe liver or kidney disorders.
Patients permanently treated with opioids, cannabis, immunosuppressive agents (e.g. corticoids, immunsuppressives) or alpha/beta-a(nta)gonists
Patients with pain as a consequence of a severe psychiatric disease (bipolar disorder, psychosis, personality disorder, severe depression, substance abuse) as well as severe systematic disorders or neurological disorders
Participation in other clinical studies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jost Langhorst, Prof.
Phone
0049951-50311251
Email
jost.langhorst@sozialstiftung-bamberg.de
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Schmid, Dr.
Phone
0049951-50316933
Email
sarah.schmid@sozialstiftung-bamberg.de
Facility Information:
Facility Name
Sozialstiftung Bamberg, Klinik für Intergrative Medizin
City
Bamberg
State/Province
Bayern
ZIP/Postal Code
96049
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jost Langhorst, Prof.
Phone
0049951-503-11251
Email
jost.langhorst@sozialstiftung-bamberg.de
First Name & Middle Initial & Last Name & Degree
Sarah Schmid, Dr.
Phone
095150311650
Email
sarah.schmid@sozialstiftung-bamberg.de
First Name & Middle Initial & Last Name & Degree
Jost Langhorst, Prof.
12. IPD Sharing Statement
Learn more about this trial
Evaluation of an Integrative Medicine Outpatient Clinical Setting for Post-COVID-19 Patients
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