Clinical trial NCT04299165: Smartphone-App as Maintenance Program in COPD
Official title: Impact of a Smartphone Application (KAIA COPD-App) in Combination With Activity Monitoring as Maintenance Program Following Pulmonary Rehabilitation in COPD: an International Multi-centered Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Pulmonary Disease, Chronic Obstructive
COPD
Medical Mobile application
Digital Therapeutics
Lead sponsor: Kaia Health Software
Sponsor class: INDUSTRY
First posted: 2020-03-06
Enrollment: 104
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 improvements in PA following Pulmonary Rehabilitation (PR), however are sparsely reported. Therefore, the investigators conduct this trial to evaluate the effectiveness of using a COPD management program delivered to the patient through a mobile medical application Kaia COPD-App, after the completion of a PR.

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 program (Arm 1) or an active comparator i.e. usual care (Arm 2). Patients completing an in-hospital PR-Program and consenting to participate in the study will be screened for the inclusion and exclusion criteria and enrolled in the study. After fulfillment of the screening requirements, they will be randomized into one of the two arms with parallel group assignment in a 1:1 ratio. The training program will be delivered to the participants grouped to the arm 1 through KAIA COPD-App and arm 2 as provided in regular recommendations or standard of care through the PI. In total, 104 participants will be included to the trial. Treatment period will last for 24 weeks. Electronic versions of Questionnaires will be used to collect patient reported assessments remotely. The primary outcome measure is the change in physical activity of the intervention group in comparison to the control group, measured over one week as mean steps per day with the Polar A 370 activity tracker, from baseline (end of PR) to 6-months follow-up. The secondary outcome measures are functional exercise capacity, health status, sleep quality, exacerbation rate, depression and anxiety symptoms assessed at several intervals.

This study seeks to prove the implications of the Kaia COPD mobile application in COPD patients after PR. The app offers educational, exercise training plus activity monitoring and motivational program that can be easily implemented in the patient's home-setting enabling patients.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Steps per day as mean over one week from baseline until the treatment end
timeFrame: Every day for 6 months
Secondary outcomes:
measure: Dyspnea
timeFrame: Baseline, Visit 5 (12 weeks) and Visit 8( 24 weeks)
measure: Functional exercise capacity using I min Sit to stand test
timeFrame: Baseline (day 0), Visit 5 (12 weeks) and Visit 8( 24 weeks)
measure: Quality of life through SAS-CRQ
timeFrame: Baseline (day 0), Visit 5 (12 weeks) and Visit 8( 24 weeks)
measure: Subjective health status
timeFrame: At the Baseline (Day 0) and every 4 weeks (V2 to V8) until the end of treatment period of 24 weeks
measure: Sleep efficacy and total sleep time
timeFrame: Every night for 6 months of treatment period
measure: Motivation for reaching his or her individual defined goal of physical activity
timeFrame: At the Baseline (Day 0) and every 4 weeks (V2 to V8) until the end of treatment period of 24 weeks
measure: Assessment of usability
timeFrame: End of the treatment period of 24 weeks from baseline
measure: Rate, number and severity of adverse events
timeFrame: At baseline (day 0) and every 2 weeks after, until the end of the treatment period of 24 weeks
measure: Rate, number and severity of device deficiencies
timeFrame: At baseline(day 0) and every 2 weeks after, until the end of the treatment period of 24 weeks
measure: Hospital Anxiety and Depression Scale
timeFrame: Baseline (day 0), Visit 5 (12 weeks) and Visit 8( 24 weeks)
Other outcomes:
Locations:
city: Schönau am Königssee
country: Germany
facility: Koczulla
city: Wald
country: Switzerland
facility: Zürcher RehaZentren Wald
Study officials:
affiliation: Reha Zentrum Wald, Zürich
name: Marc Spielmanns, MD
role: PRINCIPAL_INVESTIGATOR
References: