TELEMEdical moNiTORing for COPD Patients

Phase 4

Recruiting

Conditions: J44
Other chronic obstructive pulmonary disease

Registration Number: DRKS00027961

Lead Sponsor: Deutsches Zentrum für Luft- und Raumfahrt (DLR)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 218

Inclusion Criteria

COPD patients (ICD 10 J44.0-J44.9);
At least one documented exacerbation in the last 365 days;
Present, signed patient participation form/consent form;
Patients of participating study sites;
Statutory health insurance;
Own smartphone;
Outpatient pulmonologist participates in TELEMENTOR (for inpatient enrollment); If the pneumology practice is unable to provide the COPD nurse, this function can also be carried out by the enrolling clinic, which is in close contact with the pneumology practice.

Exclusion Criteria

Patients with guardians;
Patients with significant immobility as assessed by the study physician;
Lack of German language skills as assessed by the study physician;
Private health insurance;
Other reasons that speak against participation in the intervention according to the assessment of the treating physician (e.g., patients with acute depression or psychosis);
Participation in other studies should only take place after consultation with the treating physician

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of protocol-defined pulmonary exacerbations during the entire observation period;<br><br>Data collection time points:<br>t0 = study enrollment;<br>t1 = 1 weeks after study enrollment;<br>t2 = 4 weeks after study enrollment;<br>t3 = 3 months after study enrollment;<br>t4 = 6 months after study enrollment;<br>t5 = 9 months after study enrollment;<br>t6 = 12 months after study enrollment

Secondary Outcome Measures

Name	Time	Method
umber of COPD-associated hospitalizations per patient;<br>Number of COPD-associated intensive care unit stays;<br>Disease-related quality of life (Measured using the Saint George's Respiratory Questionnaire (SGRQ));<br>Health-related quality of life (Measured using the CAT score);<br><br>Survey time points, respectively:<br>t0 = study enrollment;<br>t1 = 1 weeks after study enrollment;<br>t2 = 4 weeks after study enrollment;<br>t3 = 3 months after study enrollment;<br>t4 = 6 months after study enrollment;<br>t5 = 9 months after study enrollment;<br>t6 = 12 months after study enrollment