Pulmonary Disease, Chronic ObstructiveAMOPURNCT04299165
Smartphone-App as Maintenance Program in COPD
A study testing Kaia COPD Application in people with Pulmonary Disease, Chronic Obstructive, run by Kaia Health Software at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Kaia COPD Application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 9 Aug 2019to 3 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
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.
Read the 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Kaia COPD Application, Usual Care
- Keywords
- Pulmonary Disease, Chronic Obstructive, COPD, Medical Mobile application, Digital Therapeutics
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kaia COPD ApplicationDevice
The study intervention consists of training sessions conducted daily by the patient via the COPD-App.
Usual CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Device: KAIA COPD-App (Medical Mobile Application). | Experimental | The study intervention is an exercise training program that requires only a chair or water bottles, consisting of training elements with progressive levels of intensity, individually adaptable to the participant's exercise level. This training program is delivered to the participants with the help of KAIA COPD-App. Additionally, the Polar A370 watch will collect the daily symptoms and training log during each session for the Database. Receives: Device: Kaia COPD Application |
| Usual Care | Active comparator | The Training of the control-group is performed by regular recommendations/ Standard of care. Standard of care in this context means to hand out the brochure " Besser Leben mit COPD " including an emergency plan, providing exercise training examples, to hand out addresses of out-patient physiotherapists and to hand out a detailed medical report including medical recommendations.Additionally, the Polar A370 watch will collect the daily symptoms and training log during each session for the Database. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steps per day as mean over one week from baseline until the treatment end
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).
Measured: Every day for 6 months
Secondary outcomes (10)
Dyspnea
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)
Measured: Baseline, Visit 5 (12 weeks) and Visit 8( 24 weeks)
Functional exercise capacity using I min Sit to stand test
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.
Measured: Baseline (day 0), Visit 5 (12 weeks) and Visit 8( 24 weeks)
Quality of life through SAS-CRQ
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).
Measured: Baseline (day 0), Visit 5 (12 weeks) and Visit 8( 24 weeks)
Subjective health status
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.
Measured: At the Baseline (Day 0) and every 4 weeks (V2 to V8) until the end of treatment period of 24 weeks
Sleep efficacy and total sleep time
Sleep efficacy (SE) and total sleep time (TST)will be measured by the Polar A370 Watch every night during the treatment period.
Measured: Every night for 6 months of treatment period
Motivation for reaching his or her individual defined goal of physical activity
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.
Measured: At the Baseline (Day 0) and every 4 weeks (V2 to V8) until the end of treatment period of 24 weeks
Assessment of usability
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.
Measured: End of the treatment period of 24 weeks from baseline
Rate, number and severity of adverse events
The AEs and SAEs will be documented to assess the safety related to the use of the application and trainings, in the home settings.
Measured: At baseline (day 0) and every 2 weeks after, until the end of the treatment period of 24 weeks
Rate, number and severity of device deficiencies
The DDs will be documented to assess the performance of the device and usability.
Measured: At baseline(day 0) and every 2 weeks after, until the end of the treatment period of 24 weeks
Hospital Anxiety and Depression Scale
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.
Measured: Baseline (day 0), Visit 5 (12 weeks) and Visit 8( 24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start9 Aug 2019
- Primary completion2 Jun 2021
- Study completion3 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaia Health Software
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Spielmanns, MD, Principal investigator, Reha Zentrum Wald, Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299165
- Sponsor's protocol ID
- Kaia COPD 001
- Other IDs
- DRKS00017275
- Acronym
- AMOPUR
- Status last verified
- Jul 2021
- First submitted
- 19 Feb 2020
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04299165
- Acronym / sponsor ID
- AMOPUR / Kaia COPD 001
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary Disease, Chronic Obstructive, COPD, Medical Mobile application, Digital Therapeutics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Kaia Health SoftwareIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2019 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 3 Jul 2021 (actual)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device: KAIA COPD-App (Medical Mobile Application). | Experimental | Device: Kaia COPD ApplicationThe study intervention is an exercise training program that requires only a chair or water bottles, consisting of training elements with progressive levels of intensity, individually adaptable to the participant's exercise level. This training program is delivered to the participants with the help of KAIA COPD-App. Additionally, the Polar A370 watch will collect the daily symptoms and training log during each session for the Database. |
| Usual Care | Active comparator | Other: Usual CareThe Training of the control-group is performed by regular recommendations/ Standard of care. Standard of care in this context means to hand out the brochure " Besser Leben mit COPD " including an emergency plan, providing exercise training examples, to hand out addresses of out-patient physiotherapists and to hand out a detailed medical report including medical recommendations.Additionally, the Polar A370 watch will collect the daily symptoms and training log during each session for the Database. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kaia COPD ApplicationThe study intervention consists of training sessions conducted daily by the patient via the COPD-App. | Device | Device: KAIA COPD-App (Medical Mobile Application). |
| Usual CareThe 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. | Other | Usual Care |
Primary outcome
Steps per day as mean over one week from baseline until the treatment end
Time frame: 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).
10 secondary outcomes
Dyspnea
Time frame: Baseline, Visit 5 (12 weeks) and Visit 8( 24 weeks)
Functional exercise capacity using I min Sit to stand test
Time frame: Baseline (day 0), Visit 5 (12 weeks) and Visit 8( 24 weeks)
Quality of life through SAS-CRQ
Time frame: Baseline (day 0), Visit 5 (12 weeks) and Visit 8( 24 weeks)
Subjective health status
Time frame: At the Baseline (Day 0) and every 4 weeks (V2 to V8) until the end of treatment period of 24 weeks
Sleep efficacy and total sleep time
Time frame: Every night for 6 months of treatment period
Motivation for reaching his or her individual defined goal of physical activity
Time frame: At the Baseline (Day 0) and every 4 weeks (V2 to V8) until the end of treatment period of 24 weeks
Assessment of usability
Time frame: End of the treatment period of 24 weeks from baseline
Rate, number and severity of adverse events
Time frame: At baseline (day 0) and every 2 weeks after, until the end of the treatment period of 24 weeks
Rate, number and severity of device deficiencies
Time frame: At baseline(day 0) and every 2 weeks after, until the end of the treatment period of 24 weeks
Hospital Anxiety and Depression Scale
Time frame: Baseline (day 0), Visit 5 (12 weeks) and Visit 8( 24 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Spielmanns, MD principal investigator
Reha Zentrum Wald, Zürich
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kaia COPD Application in people with Pulmonary Disease, Chronic Obstructive, run by Kaia Health Software at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steps per day as mean over one week from baseline until the treatment end (time frame: Every day for 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.