Clinical trial NCT06251518: Investigating the Effectiveness of Vimida
Official title: Investigating the Effectiveness of Vimida, a Digital Intervention for People Suffering From Post-viral Chronic Fatigue After COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Long COVID
Post COVID-19 Condition
Lead sponsor: Gaia AG
Sponsor class: INDUSTRY
Collaborators: name: Medical School Hamburg
name: Institut Long-Covid Rostock
First posted: 2024-02-09
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial (RCT) with 160 patients suffering from fatigue after COVID-19 infection aims to investigate the effectiveness of the unguided digital therapeutic vimida for reducing post-COVID-19 fatigue. Inclusion criteria are: male, female or non-binary, age ≥18 years, diagnosis of post-COVID-19 fatigue, ≥3 months since the last infection with COVID-19, fatigue severity score (cut-off) of ≥ 16 on the Chalder Fatigue Scale (CFQ-11), consent to participation, and sufficient German language skills. Exclusion criteria are a known psychiatric or somatic condition that can explain the fatigue and current participation in a multidisciplinary rehabilitation program aimed to ameliorate the consequences of COVID-19.

Patients will be randomized and allocated to either an intervention group, in which they will receive access to vimida in addition to treatment as usual (TAU; n=80), or to a control group, in which they will receive access to TAU only (n=80).

The primary endpoint will be fatigue symptoms with three months post-allocation (T1) being the primary time point for assessment of effectiveness. Six months post-allocation (T2) will be used as follow-up assessment of endpoints. Secondary endpoints will be depressive symptoms, mental health-related quality of life, work/social functioning, somatic symptoms, and anxiety symptoms.


Eligibility criteria: Inclusion Criteria:

* male, female or non-binary
* age ≥ 18
* diagnosis of post-COVID-19 fatigue (ICD-10 U08.9, or U09.9 in conjunction with G93.3), secured via a telemedical visit
* ≥ 3 months since COVID-19 infection that preceded fatigue symptoms
* elevated levels of fatigue: cut-off of ≥ 16 on the CFQ-11
* consent to participation
* sufficient knowledge of the German language

Exclusion Criteria:

* known somatic or psychiatric condition that can explain the fatigue (e.g., cancer, multiple sclerosis, severe depression)
* current participation in a multidisciplinary rehabilitation program aimed at ameliorating the consequences of COVID-19

Primary outcomes:
measure: Fatigue symptom severity
timeFrame: 3 months
Secondary outcomes:
measure: Depressive symptoms
timeFrame: 3 months
measure: Health-related quality of life
timeFrame: 3 months
measure: Functioning
timeFrame: 3 months
measure: Somatic symptoms
timeFrame: 3 months
measure: Anxiety
timeFrame: 3 months
Other outcomes:
measure: Fatigue symptom severity
timeFrame: 6 months
measure: Depressive symptoms
timeFrame: 6 months
measure: Health-related quality of life
timeFrame: 6 months
measure: Functioning
timeFrame: 6 months
measure: Somatic symptoms
timeFrame: 6 months
measure: Anxiety
timeFrame: 6 months
Locations:
city: Hamburg
country: Germany
facility: GAIA
Study officials:
affiliation: Medical School Hamburg
name: Johanna Schröder, PhD
role: PRINCIPAL_INVESTIGATOR
References: