Status:
COMPLETED
Smartphone-App as Maintenance Program in COPD
Lead Sponsor:
Kaia Health Software
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
Increasing Physical activity (PA) is considered to be an important factor in an efficient management of the chronic obstructive pulmonary disease (COPD). The successful methods required to achieve imp...
Detailed Description
This is a randomized, controlled, open-label, multi-centered trial carried out at in-patient PR-hospital centers in Germany and Switzerland . The interventions will involve use of KAIA COPD-app progra...
Eligibility Criteria
Inclusion
- COPD Patients willing and able to sign informed consent for use of their pseudonymized clinical data within the scope of the present interventional trial
- COPD patients who have completed an in-hospital pulmonary rehabilitation program with an average duration of 2-3 weeks.
- Diagnosis of COPD, defined as forced expiratory volume in 1s/forced vital capacity (FEV1/FVC) \<70% predicted, FEV1\<80 % predicted after bronchodilation, with or without chronic symptoms (cough, sputum production) corresponding to a GOLD stage II-IV
- Completion of the screening period and fulfilling of the randomization criteria as defined by the protocol
- Ability to use a smartphone and smartphone-apps
- Willingness to wear an activity tracker during study period of 6 months
- Patients ≥40 years of age.
- Knowledge of German language to understand study material, assessments and contents of the COPD-App
Exclusion
- The Patient is not able to conduct the exercise training program due to physical, cognitive or safety reasons, as judged by investigator; e.g., lower limb joint surgery within preceding 3 months, unstable cardiac disease, predominant neurological limitations, planned surgical or other interventions disturbing the study intervention.
- Significant psychiatric disorders, legal incapacity or limited legal capacity.
- Patients participation in another clinical trial with an investigational medication within 30 days prior to study entry.
- Patients already using the KAIA COPD App
Key Trial Info
Start Date :
August 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 3 2021
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT04299165
Start Date
August 9 2019
End Date
July 3 2021
Last Update
July 28 2021
Active Locations (2)
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1
Koczulla
Schönau am Königssee, Germany
2
Zürcher RehaZentren Wald
Wald, Switzerland, 8636