Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD, NIV, Telemonitoring
Brief summary
This study in patients suffering of Chronic Obstructive Pulmonary disease (COPD) aims to investigate whether telemonitoring of their non invasive ventilation (NIV) device together with targeted, tailored intervention in case of increasing symptoms or ventilation abnormalities improves the therapy adherence and effectiveness and can reduce the need for hospitalizations.
Detailed description
54 NIV naive COPD patients will be randomized to either telemonitoring care with a data-based intervention scheme or standard care according to the guideline of the German Society of Pneumology. Primary objective: Adherence to ventilation in the intervention group versus control group. Secondary objective: Comparisons between the control and intervention groups, over time and against each other, in terms of: * Health-related quality of life assessed by SGRQ * Symptomatology based on blood gas analyses, CAT score, mMRC score and S3-NIV score * Therapy quality according to therapy parameters from device data * Number of hospitalizations and physician visits * Evaluation of the impact of feedback and interventions on therapy adherence, symptomatology and therapy data.
Interventions
OTHERTelemonitoring Care
NIV, Supplies as needed, especially masks, tubes, humidifiers, SpO2 sensor and modems.
OTHERStandard Care
NIV, Supplies as needed, especially masks, tubes, humidifiers, and modems
Sponsors
Heinen und Löwenstein GmbH & Co. KG
Georg Nilius, Prof DR med
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, double-arm, controlled-randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* NIV-naive / Continuation after 3 Months Interruption * Indication for initiation of NIV according to S2k guideline of the German Society of Pneumology * Presence of the signed informed consent
Exclusion criteria
* Absence of signed written informed consent for data protection and study participation. * contraindication to PAP therapy * Participation in another study that influences the setting of NIV therapy through specifications regarding device settings or titration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence [hours/day] | 12 Months | Usage of Ventilator in hours per day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QOL [unit] | Survey at 3 dates: 2, 6 und 12 Months | Health related Quality of Life by SGRQ-Score \[higher units represent worse outcome\] |
Other
| Measure | Time frame | Description |
|---|---|---|
| mMRC [score] | Survey at 3 dates: 2, 6 und 12 Months | Modified Medical Research Council, Score 0 to 4, higher units represent worse outcome |
| Hospitalizations [Nr] | 12 Months | Number of hospitalizations/physician visits |
| PCO2 [mmHg] | Survey at 3 dates: 2, 6 und 12 Months | Carbon dioxide partial pressure from Blood Gas Analysis |
| S3-NIV [score] | Survey at 3 dates: 2, 6 und 12 Months | S3-NIV questionnaire for the assessment of home NIV, Score 0 to10, lower units represent worse outcome |
| CAT [score] | Survey at 3 dates: 2, 6 und 12 Months | COPD Assessment Test, Score 0 to 40, higher units represent worse outcome |
Countries
Germany
Outcome results
None listed