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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

Organizational Data

DRKS-ID:
DRKS00017275
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2019-06-27
Last update in DRKS:
2019-10-07
Registration type:
Prospective

Acronym/abbreviation of the study

KAIA COPD-001

URL of the study

No Entry

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).

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.

Health condition or problem studied

ICD10:
J44 - Other chronic obstructive pulmonary disease
Healthy volunteers:
No Entry

Interventions, Observational Groups

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

Endpoints

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.
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

Study Design

Purpose:
Treatment
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
  • Switzerland
Number of study centers:
Multicenter study
Recruitment location(s):
  • Medical center Pneumologie, Zürcher RehaZentren Wald Wald, CH
  • Medical center Fachzentrum für Pneumologie Schön Klinik Berchtesgadener Land Schönau am Königssee

Recruitment period and number of participants

Planned study start date:
2019-07-01
Actual study start date:
2019-08-09
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
104
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
40 Years
Maximum Age:
no maximum age
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

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

Addresses

Primary Sponsor

Kaia Health Software GmbH
Dr. Stephan Huber
Siegfriedstr. 8
80803 München
Germany
Telephone:
+49-89-20207057
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
No

Contact for Scientific Queries

Zürcher RehaZentren Wald
PD Dr. med. Marc Spielmanns
Faltigbergstrasse 7
8636 Wald
Switzerland
Telephone:
+41 55 256 68 00
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Zürcher RehaZentren Wald
PD Dr. med Marc Spielmanns
Faltigbergstr. 7
8636 Wald
Switzerland
Telephone:
+41 55 256 68 00
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Zürcher RehaZentren Wald
PD Dr. med. Marc Spielmanns
Faltigbergstrasse 7
8636 Wald
Switzerland
Telephone:
+41 55 256 68 00
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)

Kaia Health Software GmbH
Siegfriedstr. 8
80803 München
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2019-04-26
Ethics committee number:
2019-00766
Vote of the Ethics Committee:
Approved
Date of the vote:
2019-06-25

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry