Trial document




drksid header

  DRKS00017275

Trial Description

start of 1:1-Block title

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 randomised controlled trial

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

KAIA COPD-001

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The purpose of this study is to investigate how the use of a smartphone application (COPD-APP) in combination with activity monitoring in patients with chronic obstructive pulmonary disease (COPD) affects physical activity, quality of life, physical fitness, symptoms, feeling and health. For this, we compare people who carry out the program at home for half a year (training group) with persons who perform only an activity monitoring and regular tests (control group).

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The overall objective is to assess the effectiveness of the newly developed COPD-App as a maintenance program after Pulmonary Rehabilitation.
The primary objective is to assess the clinical efficacy of the COPD-App maintenance program on physical activity measured in steps/d in patients with COPD after 6 months.
Secondary objectives are to evaluate the effects of the COPD-App-program on
• Functional exercise capacity.
• Health-related quality of life (HRQoL).
• Patient reported health status.
• Exacerbations and depression and anxiety symptoms.
Other Objectives : Further we aim to explore the patients’ compliance/adherence and safety, identify factors which facilitate the implementation of the program in the patient’s home setting and to evaluate factors of the program which are especially supportive for the patients.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00017275
  •   2019/06/27
  •   [---]*
  •   no
  •   Approved
  •   2019-00766, Kantonale Ethikkomission Zürich
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   J44 -  Other chronic obstructive pulmonary disease
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Device : KAIA COPD-App (Mobile Application).
    The study intervention is an exercise training program that requires a chair and elastic bands, 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. The individualized training sessions will last approximately 15-20 minutes and will be conducted by the participants seven days per week at home during six months of the trial period.
  •   Training of the control-group is performed by regular recommendations during the study period.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

The primary outcome 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 comparing baseline to 6 months visit value.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Secondary outcomes assessed are :
• dyspnea (COPD-Assessment test (CAT))
• functional exercise capacity (1-minute Sit-to stand test)
• HRQoL (Chronic respiratory disease questionere, CRQ)
• health status (Feeling Thermometer)
• HADS (Anxiety and depression scale)
• Number of exacerbations (Questionnaire as defined by GOLD Guidelines)
• Reaching his or her individual defined goal of physical activity
• Sleep efficiency and sleep quality

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
  •   Switzerland
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2019/08/09
  •   104
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional 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 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 an inpatient pulmonary rehabilitation
• 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
• Male and female patients between (Minimum age) and ≥40 years of age, Females of child bearing potential must have a negative pregnancy test prior to entry in the study
• Knowledge of German language to understand study material, assessments and contents of the COPD-App

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Kaia Health Software GmbH
    • Mr.  Dr.  Stephan  Huber 
    • Siegfriedstr. 8
    • 80803  München
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Zürcher RehaZentren Wald
    • Mr.  PD Dr. med.  Marc  Spielmanns 
    • Faltigbergstrasse 7
    • 8636  Wald
    • Switzerland
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Zürcher RehaZentren Wald
    • Mr.  PD Dr. med  Marc  Spielmanns 
    • Faltigbergstr. 7
    • 8636  Wald
    • Switzerland
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Kaia Health Software GmbH
    • Siegfriedstr. 8
    • 80803  München
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.