Investigating the Effectiveness of Vimida

Long COVID Clinical Trial

— InvidiCO  

Official title:

Investigating the Effectiveness of Vimida, a Digital Intervention for People Suffering From Post-viral Chronic Fatigue After COVID-19 Infection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06251518
• Other study ID #: vimida RCT 2024
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: April 15, 2025

Study information

• Verified date: February 2024
• Source: Gaia AG
• Contact: Gitta A. Jacob, PhD
• Phone: +49.40.349930-374
• Email: gitta.jacob[@]gaia-group.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 160
• Est. completion date: April 15, 2025
• Est. primary completion date: April 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Long COVID

Intervention

Behavioral:
• vimida
Participants will receive access to the digital health intervention vimida in addition to TAU.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Gaia AG	Institut Long-Covid Rostock, Medical School Hamburg

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fatigue symptom severity	Chalder Fatigue Scale (CFQ-11). Total score ranging from 0-33; higher scores mean higher fatigue symptoms (worse outcome).	6 months
Other	Depressive symptoms	Patient Health Questionnaire - 9 item version (PHQ-9). Total score ranging from 0-27; higher scores mean higher depressive symptoms (worse outcome).	6 months
Other	Health-related quality of life	Assessment of Quality of Life - 8 Dimensions (AQoL-8D). Total score ranging from 0-100; higher scores mean higher quality of life (better outcome).	6 months
Other	Functioning	Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome).	6 months
Other	Somatic symptoms	Patient Health Questionnaire - 15 item version (PHQ-15). Total score ranging from 0-30; higher scores mean higher somatic symptoms (worse outcome).	6 months
Other	Anxiety	Generalized Anxiety Disorder Assessment (GAD-7). Total score ranging from 0-21; higher scores mean higher anxiety symptoms (worse outcome).	6 months
Primary	Fatigue symptom severity	Chalder Fatigue Scale (CFQ-11). Total score ranging from 0-33; higher scores mean higher fatigue symptoms (worse outcome).	3 months
Secondary	Depressive symptoms	Patient Health Questionnaire - 9 item version (PHQ-9). Total score ranging from 0-27; higher scores mean higher depressive symptoms (worse outcome).	3 months
Secondary	Health-related quality of life	Assessment of Quality of Life - 8 Dimensions (AQoL-8D). Total score ranging from 0-100; higher scores mean higher quality of life (better outcome).	3 months
Secondary	Functioning	Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome).	3 months
Secondary	Somatic symptoms	Patient Health Questionnaire - 15 item version (PHQ-15). Total score ranging from 0-30; higher scores mean higher somatic symptoms (worse outcome).	3 months
Secondary	Anxiety	Generalized Anxiety Disorder Assessment (GAD-7). Total score ranging from 0-21; higher scores mean higher anxiety symptoms (worse outcome).	3 months