Smartphone-App as Maintenance Program in COPD

NCT04299165 | Completed

• 2 other identifiers: Kaia COPD 001DRKS00017275
• Study Type: interventional
• Target: 104
• Locations: 2 countries
• Sites: 2

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Pulmonary Disease, Chronic Obstructive; COPD; Medical Mobile application; Digital Therapeutics

Outcome Measures

Primary Outcomes (1)

• 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).

  Every day for 6 months

Secondary Outcomes (10)

• Dyspnea

  Baseline, Visit 5 (12 weeks) and Visit 8( 24 weeks)

• Functional exercise capacity using I min Sit to stand test

  Baseline (day 0), Visit 5 (12 weeks) and Visit 8( 24 weeks)

• Quality of life through SAS-CRQ

  Baseline (day 0), Visit 5 (12 weeks) and Visit 8( 24 weeks)

• Subjective health status

  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

  Every night for 6 months of treatment period

Study Arms (2)

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.

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.

Other: Usual Care

Interventions

Kaia COPD Application DEVICE

The study intervention consists of training sessions conducted daily by the patient via the COPD-App.

Device: KAIA COPD-App (Medical Mobile Application).

Usual Care OTHER

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.

Usual Care

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaia Health Software: lead

Study Sites (2)

Koczulla

Schönau am Königssee, Germany

Location

Zürcher RehaZentren Wald

Wald, 8636, Switzerland

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc Spielmanns, MD

  Reha Zentrum Wald, Zürich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: March 6, 2020
• Study Start: August 9, 2019
• Primary Completion: June 2, 2021
• Study Completion: July 3, 2021
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); CH (1)