Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Pulmonary Disease, Chronic Obstructive, COPD, Medical Mobile application, Digital Therapeutics
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.
Interventions
DEVICEKaia COPD Application
The study intervention consists of training sessions conducted daily by the patient via the COPD-App.
OTHERUsual Care
The control group will also be an active control as participants receive a leaflet to convey an active lifestyle and a list of exercises to do at home.
Sponsors
Kaia Health Software
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Steps per day as mean over one week from baseline until the treatment end | Every day for 6 months | The primary outcome are the steps per day as mean over one week from baseline (second week after discharge from PR) to 6 months follow-up in the intervention group in comparison to the control group as an equivalent for the physical activity of the participants, measured by an activity tracker (Polar A370-Watch). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional exercise capacity using I min Sit to stand test | Baseline (day 0), Visit 5 (12 weeks) and Visit 8( 24 weeks) | Functional exercise capacity will be assessed by the widely-used and validated 1-min sit-to-stand test (STS). The patients are guided through an integrated video with a stop watch in an ePRO to perform the test in a right way in home settings. |
| Quality of life through SAS-CRQ | Baseline (day 0), Visit 5 (12 weeks) and Visit 8( 24 weeks) | SAS- CRQ The chronic respiratory questionnaire, a self-administered instrument, includes 20 items across four domains: dyspnea (5 items), fatigue (4 items), emotional function (7 items), and mastery (4 items). Patients will be scored for the Quality of life around their experience on a 7-point scale ranging from 1 (maximum impairment) to 7 (no impairment). |
| Subjective health status | At the Baseline (Day 0) and every 4 weeks (V2 to V8) until the end of treatment period of 24 weeks | A feeling thermometer scale allows respondents to rank how positively individuals feels about the quality of life to measure individuals' subjective health status. The scale ranges from a minimum of 0 to a maximum of 100. |
| Sleep efficacy and total sleep time | Every night for 6 months of treatment period | Sleep efficacy (SE) and total sleep time (TST)will be measured by the Polar A370 Watch every night during the treatment period. |
| Dyspnea | Baseline, Visit 5 (12 weeks) and Visit 8( 24 weeks) | Dyspnea will be assessed by the COPD Assessment Test (CAT) which measures the impact of COPD on a person's health status (8 questions, 6-point Likert-type scale) |
| Assessment of usability | End of the treatment period of 24 weeks from baseline | This assessment is linked to the intervention group using COPD App only. The use of the application will be assessed every week through patient data reports captured in the COPD Application. |
| Rate, number and severity of adverse events | At baseline (day 0) and every 2 weeks after, until the end of the treatment period of 24 weeks | The AEs and SAEs will be documented to assess the safety related to the use of the application and trainings, in the home settings. |
| Rate, number and severity of device deficiencies | At baseline(day 0) and every 2 weeks after, until the end of the treatment period of 24 weeks | The DDs will be documented to assess the performance of the device and usability. |
| Hospital Anxiety and Depression Scale | Baseline (day 0), Visit 5 (12 weeks) and Visit 8( 24 weeks) | The HADS Questionnaire will be used to measure anxiety and depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. |
| Motivation for reaching his or her individual defined goal of physical activity | At the Baseline (Day 0) and every 4 weeks (V2 to V8) until the end of treatment period of 24 weeks | This assessment is linked to the intervention group using COPD App only. During monthly visits, a certain number of steps will be fixed as a goal for the patients in the COPD application. |
Countries
Germany, Switzerland
Outcome results
None listed