Back to resultsSmartphone-App as Maintenance Program in COPD (AMOPUR)
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Kaia COPD Application
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Pulmonary Disease, Chronic Obstructive, COPD, Medical Mobile application, Digital Therapeutics
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
Sites / Locations
- Koczulla
- Zürcher RehaZentren Wald
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Device: KAIA COPD-App (Medical Mobile Application).
Usual Care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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)
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.
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).
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.
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.
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.
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.
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.
Rate, number and severity of device deficiencies
The DDs will be documented to assess the performance of the device and usability.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04299165
Brief Title
Smartphone-App as Maintenance Program in COPD
Acronym
AMOPUR
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
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
August 9, 2019 (Actual)
Primary Completion Date
June 2, 2021 (Actual)
Study Completion Date
July 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaia Health Software
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Pulmonary Disease, Chronic Obstructive, COPD, Medical Mobile application, Digital Therapeutics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Device: KAIA COPD-App (Medical Mobile Application).
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Kaia COPD Application
Intervention Description
The study intervention consists of training sessions conducted daily by the patient via the COPD-App.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Steps per day as mean over one week from baseline until the treatment end
Description
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).
Time Frame
Every day for 6 months
Secondary Outcome Measure Information:
Title
Dyspnea
Description
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)
Time Frame
Baseline, Visit 5 (12 weeks) and Visit 8( 24 weeks)
Title
Functional exercise capacity using I min Sit to stand test
Description
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.
Time Frame
Baseline (day 0), Visit 5 (12 weeks) and Visit 8( 24 weeks)
Title
Quality of life through SAS-CRQ
Description
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).
Time Frame
Baseline (day 0), Visit 5 (12 weeks) and Visit 8( 24 weeks)
Title
Subjective health status
Description
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.
Time Frame
At the Baseline (Day 0) and every 4 weeks (V2 to V8) until the end of treatment period of 24 weeks
Title
Sleep efficacy and total sleep time
Description
Sleep efficacy (SE) and total sleep time (TST)will be measured by the Polar A370 Watch every night during the treatment period.
Time Frame
Every night for 6 months of treatment period
Title
Motivation for reaching his or her individual defined goal of physical activity
Description
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.
Time Frame
At the Baseline (Day 0) and every 4 weeks (V2 to V8) until the end of treatment period of 24 weeks
Title
Assessment of usability
Description
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.
Time Frame
End of the treatment period of 24 weeks from baseline
Title
Rate, number and severity of adverse events
Description
The AEs and SAEs will be documented to assess the safety related to the use of the application and trainings, in the home settings.
Time Frame
At baseline (day 0) and every 2 weeks after, until the end of the treatment period of 24 weeks
Title
Rate, number and severity of device deficiencies
Description
The DDs will be documented to assess the performance of the device and usability.
Time Frame
At baseline(day 0) and every 2 weeks after, until the end of the treatment period of 24 weeks
Title
Hospital Anxiety and Depression Scale
Description
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.
Time Frame
Baseline (day 0), Visit 5 (12 weeks) and Visit 8( 24 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Spielmanns, MD
Organizational Affiliation
Reha Zentrum Wald, Zürich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Koczulla
City
Schönau am Königssee
Country
Germany
Facility Name
Zürcher RehaZentren Wald
City
Wald
ZIP/Postal Code
8636
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
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Smartphone-App as Maintenance Program in COPD
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