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

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00017275
• Date of registration: 27/06/2019
• Prospective Registration: Yes
• Primary sponsor: Kaia Health Software GmbH
• Public 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
• Scientific 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 - KAIA COPD-001
• Date of first enrolment: 09/08/2019
• Target sample size: 104
• Recruitment status: Recruiting
• URL: http://drks.de/search/en/trial/DRKS00017275
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: treatment
• Phase: N/A

Countries of recruitment

Germany, Switzerland

Contacts

• Name: Marc Spielmanns
• Affiliation: Zürcher RehaZentren Wald

• Name: Marc Spielmanns
• Affiliation: Zürcher RehaZentren Wald

Key inclusion & exclusion 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 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
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

Age minimum: 40 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

Other chronic obstructive pulmonary disease

J44

Intervention(s)

Group 1: 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.
Group 2: Training of the control-group is performed by regular recommendations during the study period.

Primary Outcome(s)

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.

Secondary Outcome(s)

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

Source(s) of Monetary Support

Kaia Health Software GmbH

Ethics review

Status: Approved
Approval date: 25/06/2019
Contact:

Results

• URL: http://drks.de/search/en/trial/DRKS00017275#studyResults