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Complementary Self-help Strategies for Patients With Post-COVID-19 Syndrome (NASH-POCO)

Primary Purpose

Post-COVID-19 Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Complementary self-help strategies in addition to treatment as usual
Treatment as usual
Sponsored by
Universität Duisburg-Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-COVID-19 Syndrome focused on measuring complementary medicine, COVID-19, post-COVID-19 Syndrome, randomized controlled trial, self-help

Eligibility Criteria

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

Inclusion Criteria: Age of 18 years and older Confirmed COVID-19 diagnosis by: 1. polymerase chain reaction (PCR) test or 2. physician's letter/medical certificate/quarantine order due to ICD-10-GM U07.1 G or ICD-10-GM U09.9 G Sequelae symptoms, new symptoms/disabilities, or worsening of a pre-existing medical condition that occurred in the first 3 months after confirmed SARS-CoV-2 infection and persisted for more than 2 months At least 8 points (moderate symptom burden) out of a possible 32 points on the Somatic Symptom Scale-8 (SSS-8) Exclusion Criteria: Patients who were treated with invasive ventilation during active SARS-CoV-2 infection Severe comorbid mental illness (e.g. addiction diagnosis, major depression) or other severe comorbid somatic illness (e.g. cancer without remission, severe pre-existing cardiovascular disease, insufficiency of other organs such as kidney or liver, acute febrile infection, other severe neurologic disease) Pregnancy or lactation Current pension application Simultaneous participation in other clinical/interventional trials

Sites / Locations

  • Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-EssenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Complementary self-help strategies in addition to treatment as usual

Treatment as usual

Arm Description

The experimental group consists of 10 weeks of group treatments with educative and actively practicing elements. The patients will also receive a booklet with self-help basics and descriptions of the techniques, which should facilitate the correct practice at home. Parallel treatment as usual is allowed.

The active control group consists a 16-week waiting period, where treatment as usual is allowed. In case of acute worsening/progression of the symptoms, consultations with the study physician are offered anytime. After the waiting period, the control group will be offered the same units as in the experimental group.

Outcomes

Primary Outcome Measures

Post-COVID-19 symptom burden
Somatic Symptom Scale-8 (SSS-8): self-report scale from 0 to 32 points with higher scores indicating higher level of burden

Secondary Outcome Measures

Post-COVID-19 symptom burden
Somatic Symptom Scale-8 (SSS-8): self-report scale from 0 to 32 points with higher scores indicating higher level of burden
Post-COVID-19 functional status (self-reported)
Post-COVID-19 Functional Status Scale - Patient Version (PCFS): self-report scale from 0 - 4 points with 0 = no functional limitations and 4 = severe functional limitations
Post-COVID-19 functional status (self-reported)
Post-COVID-19 Functional Status Scale - Patient Version (PCFS): self-report scale from 0 - 4 points with 0 = no functional limitations and 4 = severe functional limitations
Health-related quality of life
Short-form Health Survey (SF-12): self-report scale from 0 - 100 with higher score indicates a better health state
Health-related quality of life
Short-form Health Survey (SF-12): self-report scale from 0 - 100 with higher score indicates a better health state
Fatigue
Chalder fatigue-scale (CFS): self-report scale from 0 - 33 points with higher scores indicating higher level of physical and mental fatigue
Fatigue
Chalder fatigue-scale (CFS): self-report scale from 0 - 33 points with higher scores indicating higher level of physical and mental fatigue
Anxiety and depression
Hospital Anxiety and Depression Scale (HADS): self-report scale form 0 - 42 with higher scores indicating higher levels of anxiety and depression
Anxiety and depression
Hospital Anxiety and Depression Scale (HADS): self-report scale form 0 - 42 with higher scores indicating higher level of anxiety and depression
Insomnia
Insomnia Severity Index (ISI): self-report scale from 0 - 28 points with higher score indicating higher level of insomnia
Insomnia
Insomnia Severity Index (ISI): self-report scale from 0 - 28 points with higher score indicating higher level of insomnia
Cardiovascular performance
6-Minute-Walking-Test (6MWT): a longer traveled distance indicates a higher level of cardiovascular/pulmonary capacity
Cardiovascular performance
6-Minute-Walking-Test (6MWT): a longer traveled distance indicates a higher level of cardiovascular/pulmonary capacity
Pulmonary performance
Borg Breathlessness Scale (Borg-CR10-Scale): scale from 0-10 with higher scores indicating higher breathlessness/dyspnea - assesed subsequent to the 6-Minute-Walking-Test
Pulmonary performance
Borg Breathlessness Scale (Borg-CR10-Scale): scale from 0-10 with higher scores indicating higher breathlessness/dyspnea - assesed subsequent to the 6-Minute-Walking-Test
Post-COVID-19 functional status (physician-reported)
Post-COVID-19 Functional Status Scale - Physician Version (PCFS): physician-report scale from 0 - 4 points with 0 = no functional limitations and 4 = severe functional limitations
Post-COVID-19 functional status (physician-reported)
Post-COVID-19 Functional Status Scale - Physician Version (PCFS): physician-report scale from 0 - 4 points with 0 = no functional limitations and 4 = severe functional limitations
Adverse events
All adverse events in relation and unrelated to the intervention

Full Information

First Posted
April 2, 2023
Last Updated
April 26, 2023
Sponsor
Universität Duisburg-Essen
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1. Study Identification

Unique Protocol Identification Number
NCT05798221
Brief Title
Complementary Self-help Strategies for Patients With Post-COVID-19 Syndrome
Acronym
NASH-POCO
Official Title
Complementary Self-help Strategies for Patients With Post-COVID-19 Syndrome: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2023 (Actual)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (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
Individuals affected by SARS-CoV-2 infection may subsequently be affected by the so-called post-COVID syndrome. The aim of the present study is to investigate the effects of a multimodal 10-week group program consisting of self-help strategies based on complementary medicine approaches of TEM (Traditional European Medicine), TCM (Traditional Chinese Medicine), and TIM (Traditional Indian Medicine) in addition to treatment as usual versus treatment as usual alone (no active study intervention/waiting list). Endpoints of the study include subjective quantitative and qualitative as well as objective (physician-reported) variables.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-COVID-19 Syndrome
Keywords
complementary medicine, COVID-19, post-COVID-19 Syndrome, randomized controlled trial, self-help

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Complementary self-help strategies in addition to treatment as usual
Arm Type
Experimental
Arm Description
The experimental group consists of 10 weeks of group treatments with educative and actively practicing elements. The patients will also receive a booklet with self-help basics and descriptions of the techniques, which should facilitate the correct practice at home. Parallel treatment as usual is allowed.
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
The active control group consists a 16-week waiting period, where treatment as usual is allowed. In case of acute worsening/progression of the symptoms, consultations with the study physician are offered anytime. After the waiting period, the control group will be offered the same units as in the experimental group.
Intervention Type
Behavioral
Intervention Name(s)
Complementary self-help strategies in addition to treatment as usual
Intervention Description
The 10-week group program consists of self-help strategies from complementary medicine approaches of TEM (Traditional European Medicine), TCM (Traditional Chinese Medicine), and TIM (Traditional Indian Medicine) in addition to treatment as usual
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
The active control group consists a 16-week waiting period, where treatment as usual is allowed. In case of acute worsening/progression of the symptoms, consultations with the study physician are offered anytime. After the waiting period, the control group will be offered the same units as in the experimental group.
Primary Outcome Measure Information:
Title
Post-COVID-19 symptom burden
Description
Somatic Symptom Scale-8 (SSS-8): self-report scale from 0 to 32 points with higher scores indicating higher level of burden
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Post-COVID-19 symptom burden
Description
Somatic Symptom Scale-8 (SSS-8): self-report scale from 0 to 32 points with higher scores indicating higher level of burden
Time Frame
Week 10
Title
Post-COVID-19 functional status (self-reported)
Description
Post-COVID-19 Functional Status Scale - Patient Version (PCFS): self-report scale from 0 - 4 points with 0 = no functional limitations and 4 = severe functional limitations
Time Frame
Week 10
Title
Post-COVID-19 functional status (self-reported)
Description
Post-COVID-19 Functional Status Scale - Patient Version (PCFS): self-report scale from 0 - 4 points with 0 = no functional limitations and 4 = severe functional limitations
Time Frame
Week 16
Title
Health-related quality of life
Description
Short-form Health Survey (SF-12): self-report scale from 0 - 100 with higher score indicates a better health state
Time Frame
Week 10
Title
Health-related quality of life
Description
Short-form Health Survey (SF-12): self-report scale from 0 - 100 with higher score indicates a better health state
Time Frame
Week 16
Title
Fatigue
Description
Chalder fatigue-scale (CFS): self-report scale from 0 - 33 points with higher scores indicating higher level of physical and mental fatigue
Time Frame
Week 10
Title
Fatigue
Description
Chalder fatigue-scale (CFS): self-report scale from 0 - 33 points with higher scores indicating higher level of physical and mental fatigue
Time Frame
Week 16
Title
Anxiety and depression
Description
Hospital Anxiety and Depression Scale (HADS): self-report scale form 0 - 42 with higher scores indicating higher levels of anxiety and depression
Time Frame
Week 10
Title
Anxiety and depression
Description
Hospital Anxiety and Depression Scale (HADS): self-report scale form 0 - 42 with higher scores indicating higher level of anxiety and depression
Time Frame
Week 16
Title
Insomnia
Description
Insomnia Severity Index (ISI): self-report scale from 0 - 28 points with higher score indicating higher level of insomnia
Time Frame
Week 16
Title
Insomnia
Description
Insomnia Severity Index (ISI): self-report scale from 0 - 28 points with higher score indicating higher level of insomnia
Time Frame
Week 10
Title
Cardiovascular performance
Description
6-Minute-Walking-Test (6MWT): a longer traveled distance indicates a higher level of cardiovascular/pulmonary capacity
Time Frame
Week 10
Title
Cardiovascular performance
Description
6-Minute-Walking-Test (6MWT): a longer traveled distance indicates a higher level of cardiovascular/pulmonary capacity
Time Frame
Week 16
Title
Pulmonary performance
Description
Borg Breathlessness Scale (Borg-CR10-Scale): scale from 0-10 with higher scores indicating higher breathlessness/dyspnea - assesed subsequent to the 6-Minute-Walking-Test
Time Frame
Week 10
Title
Pulmonary performance
Description
Borg Breathlessness Scale (Borg-CR10-Scale): scale from 0-10 with higher scores indicating higher breathlessness/dyspnea - assesed subsequent to the 6-Minute-Walking-Test
Time Frame
Week 16
Title
Post-COVID-19 functional status (physician-reported)
Description
Post-COVID-19 Functional Status Scale - Physician Version (PCFS): physician-report scale from 0 - 4 points with 0 = no functional limitations and 4 = severe functional limitations
Time Frame
Week 10
Title
Post-COVID-19 functional status (physician-reported)
Description
Post-COVID-19 Functional Status Scale - Physician Version (PCFS): physician-report scale from 0 - 4 points with 0 = no functional limitations and 4 = severe functional limitations
Time Frame
Week 16
Title
Adverse events
Description
All adverse events in relation and unrelated to the intervention
Time Frame
Weeks 0 - 10
Other Pre-specified Outcome Measures:
Title
Treatment Expectation
Description
Treatment Credibility Scale (TCS): expectation about the treatment effectiveness measured from 0 = no effectiveness to 10 = highest possible effectiveness
Time Frame
Week 0
Title
Self-efficacy
Description
Arthritis Self-Efficacy Scale (ASES): the scale ranges from 1 to 10 with higher scores indicating more perceived efficacy
Time Frame
Week 10
Title
Self-efficacy
Description
Arthritis Self-Efficacy Scale (ASES): the scale ranges from 1 to 10 with higher scores indicating more perceived efficacy
Time Frame
Week 16
Title
Stress
Description
Perceived Stress Scale (PSS): 10-item scale, summed to create a psychological stress score of maximal 40 points with higher scores indicating greater psychological stress
Time Frame
Week 10
Title
Stress
Description
Perceived Stress Scale (PSS): 10-item scale, summed to create a psychological stress score of maximal 40 points with higher scores indicating greater psychological stress
Time Frame
Week 16
Title
Flourishing
Description
Flourishing-Scale (FS): the scale ranges from 8 (lowest possible value) to 56 (highest possible value) with higher values correspond to a person with many psychological resources and strengths
Time Frame
Week 10
Title
Flourishing
Description
Flourishing-Scale (FS): the scale ranges from 8 (lowest possible value) to 56 (highest possible value) with higher values correspond to a person with many psychological resources and strengths
Time Frame
Week 16
Title
Loneliness
Description
UCLA Loneliness Scale (UCLA-LS): the short form of the UCLA-LS constsis of 12 items, ranges from 0 to 36 points, with higher higher scores indicating greater loneliness
Time Frame
Week 10
Title
Loneliness
Description
UCLA Loneliness Scale (UCLA-LS): the short form of the UCLA-LS constsis of 12 items, ranges from 0 to 36 points, with higher higher scores indicating greater loneliness
Time Frame
Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age of 18 years and older Confirmed COVID-19 diagnosis by: 1. polymerase chain reaction (PCR) test or 2. physician's letter/medical certificate/quarantine order due to ICD-10-GM U07.1 G or ICD-10-GM U09.9 G Sequelae symptoms, new symptoms/disabilities, or worsening of a pre-existing medical condition that occurred in the first 3 months after confirmed SARS-CoV-2 infection and persisted for more than 2 months At least 8 points (moderate symptom burden) out of a possible 32 points on the Somatic Symptom Scale-8 (SSS-8) Exclusion Criteria: Patients who were treated with invasive ventilation during active SARS-CoV-2 infection Severe comorbid mental illness (e.g. addiction diagnosis, major depression) or other severe comorbid somatic illness (e.g. cancer without remission, severe pre-existing cardiovascular disease, insufficiency of other organs such as kidney or liver, acute febrile infection, other severe neurologic disease) Pregnancy or lactation Current pension application Simultaneous participation in other clinical/interventional trials
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heidemarie Haller, PhD
Phone
+4920172377384
Email
heidemarie.haller@uk-essen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Thi Thuy Nhi Cao
Phone
+4917647104822
Email
nhi.cao@uk-essen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustav Dobos, Prof. MD
Organizational Affiliation
University of Duisburg-Essen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Heidemarie Haller, PhD
Organizational Affiliation
University of Duisburg-Essen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christoph Kleinschnitz, Prof. MD
Organizational Affiliation
University of Duisburg-Essen
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mark Stettner, Prof. MD
Organizational Affiliation
University of Duisburg-Essen
Official's Role
Study Director
Facility Information:
Facility Name
Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen
City
Essen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heidemarie Haller, PhD
Phone
+4920172377384
Email
heidemarie.haller@uk-essen.de
First Name & Middle Initial & Last Name & Degree
Thi Thuy Nhi Cao
Phone
+4917647104822
Email
nhi.cao@uk-essen.de

12. IPD Sharing Statement

Plan to Share IPD
No

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Complementary Self-help Strategies for Patients With Post-COVID-19 Syndrome

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