Telemedical centre for out-of-hospital ventilation and oxygen therapy

Telemedical centre for out-of-hospital ventilation and oxygen therapy - T-CABS

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00035562

Enrollment

200

Registered

2025-03-20

Start date

2025-06-30

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

J96.1 J98.6 J44 G12 M41 E66.2 E74 G70 G71 E88 G31

Interventions

Group 1: Intervention group: Receives telemedical care. Therefore, on-site visits are replaced by video consultations. Additionally, there will be a weekly telemedical check of health data. Group 2: C

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Indication for invasive or non-invasive ventilation - Chronic ventilatory insufficiency with or without long-term oxygen therapy - Written consent to participate in the study - Ventilation using a cloud-capable device from the manufacturers BREAS Medical, Löwenstein Medical or ResMed - Sufficient experience in handling technical devices by the patient or carer/relatives - Majority (age =18 years at the time of inclusion)

Exclusion criteria

Exclusion criteria: - Participation in another telemedical intervention study - Acute ventilatory failure with indication for short-term NIV/IV - Ascertained pregnancy - Evidence of acute or persistent suicidal behaviour - Diagnosed advanced dementia - Diagnosed advanced tumour disease - Minor (<18 years) - Planned relocation outside the Berlin/Brandenburg region within the next 12 months

Design outcomes

Primary

Measure	Time frame
12 months after patient inclusion, the intervention group (IG) had a significant lower average number of unplanned contacts with the healthcare system - predominantly related to ongoing ventilator therapy - than the control group (CG).	—

Secondary

Measure	Time frame
- 12 months after patient inclusion, the IG has on average a lower symptom burden than the CG (determined on the basis of PROMs and vital signs during visits) - 12 months after patient inclusion, the IG has on average a higher quality of life than the CG (determined on the basis of PROMs and vital signs during visits) - 12 months after patient inclusion, the IG has on average more quality-adjusted life years (QALYs) than the CG (determined using PROMs and estimated life expectancy) - 12 months after patient inclusion, adherence to therapy is better in the IG than in the CG (determined on the basis of ventilation hours). - 12 months after patient inclusion, physical activity is better in the IG than in the CG (determined using the 6-minute walk test and handgrip strength measurement). - 12 months after patient inclusion, the quality of care is better in the IG than in the KG (a combined score for ventilation quality was established as a measure of the quality of care). - Compared to standard care, the new form of care is more widely accepted and better subjectively assessed (determined by PROMs and interviews). - 12 months after patient inclusion, the new form of care proves to be cost-effective (determined with the help of health economic evaluations).	—

Measure

Time frame

- 12 months after patient inclusion, the IG has on average a lower symptom burden than the CG (determined on the basis of PROMs and vital signs during visits) - 12 months after patient inclusion, the IG has on average a higher quality of life than the CG (determined on the basis of PROMs and vital signs during visits) - 12 months after patient inclusion, the IG has on average more quality-adjusted life years (QALYs) than the CG (determined using PROMs and estimated life expectancy) - 12 months after patient inclusion, adherence to therapy is better in the IG than in the CG (determined on the basis of ventilation hours). - 12 months after patient inclusion, physical activity is better in the IG than in the CG (determined using the 6-minute walk test and handgrip strength measurement). - 12 months after patient inclusion, the quality of care is better in the IG than in the KG (a combined score for ventilation quality was established as a measure of the quality of care). - Compared to standard care, the new form of care is more widely accepted and better subjectively assessed (determined by PROMs and interviews). - 12 months after patient inclusion, the new form of care proves to be cost-effective (determined with the help of health economic evaluations).

—

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026