Effectiveness of Vimida for Post-COVID Fatigue
Investigating the Effectiveness of Vimida, a Digital Intervention for People Suffering From Post-viral Chronic Fatigue After COVID-19 Infection
This study tests if a digital therapy called Vimida can help people who have been feeling tired for months after COVID-19 feel less fatigued when used with their regular treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gaia AG Industry-sponsored |
| Locations | 1 site (Hamburg) |
| Trial ID | NCT06251518 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial involves 160 patients experiencing fatigue after COVID-19 infection to evaluate the effectiveness of the unguided digital therapeutic vimida. Participants will be randomly assigned to either receive vimida alongside standard treatment or standard treatment alone. The study focuses on individuals who have been diagnosed with post-COVID-19 fatigue and have experienced symptoms for at least three months. The primary endpoint is to assess the reduction in fatigue levels using the Chalder Fatigue Scale.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with post-COVID-19 fatigue and have sufficient German language skills.
Not a fit: Patients with known psychiatric or somatic conditions that explain their fatigue or those currently in a rehabilitation program may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new digital therapeutic option for patients suffering from post-COVID-19 fatigue.
How similar studies have performed: While there have been studies on digital therapeutics for various conditions, the specific application of vimida for post-COVID fatigue is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hamburg
- Gaia — Hamburg, Germany (Recruiting)
Study contacts
- Principal investigator: Johanna Schröder, PhD — Medical School Hamburg
- Study coordinator: Gitta A. Jacob, PhD
- Email: gitta.jacob@gaia-group.com
- Phone: +49.40.349930-374
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.