Descrizione riassuntiva della sperimentazione (Fonte di dati: BASEC)
Mit dieser Studie möchten wir untersuchen, wie sich die Anwendung einer Smartphone-Applikation (COPD-APP) bei Patienten, die an einer chronisch obstruktiven Lungenerkrankung (COPD) leiden, auswirkt auf die körperliche Aktivität, die Lebensqualität, die körperliche Leistungsfähigkeit, die Symptome, den Gefühls- und den Gesundheitszustand. Dazu vergleichen wir Personen, die das Programm während drei Monaten zu Hause durchführen (Trainingsgruppe) mit Personen, die nur eine Aktivitäts-Überwachung und regelmässige Tests durchführen (Kontrollgruppe). Es wird erwartet, dass Patienten alle studienbezogenen Tätigkeiten verstehen und diese durchführen.
Zu Beginn der Studie werden die Patienten in unterschiedlichen Gruppen zugeordnet und entweder der Interventions- oder der Kontrollgruppe zugewiesen. Patientenberichtete Endpunkte werden direkt mittels eines Webformulars (fern) durch den Patienten erfasst, welches die Ergebnisse in das Studie databank einfügt. Die geplante Dauer der Studienteilnahme ist 3 Monate mit einer nachfolgenden Nachbeobachtungsperiode von 3 Monaten. Der 1MSTS wird über eine smartphonebasierte verschlüsselte Videoverbindung mit dem Prüfzentrum in Echtzeit unter Aufsicht und Anleitung des entsprechend qualifizierten Studienpersonals durchgeführt.
Malattie studiate(Fonte di dati: BASEC)
COPD
Health conditions
(Fonte di dati: WHO)
J44;Other chronic obstructive pulmonary disease
Malattia rara
(Fonte di dati: BASEC)
No
Interventi esaminati (p. es. medicamento, terapia, campagna)
(Fonte di dati: BASEC)
KAIA COPD-App (Softwareanwendung).
Die Intervention in dieser Studie besteht aus einem softwarebasierten multimodalem Trainingsprogramm mit Modulen zu körperlicher Aktivität, Patientenedukation und Entspannungs- und Atemtechniken. Es erfordert lediglich einen Stuhl und Elastikbänder. Das Trainingsprogramm beinhaltet eine kontinuierliche Steigerung der Intensität, welche individuell an die Leistungsfähigkeit des Patienten angepasst wird. Das Trainingsprogramm wird über die Kaia COPD-App durchgeführt. Individualisierte Trainingseinheiten dauern ca. 15-20 Minuten und werden von den Studienteilnehmern in der häuslichen Umgebung durchgeführt.
Interventions
(Fonte di dati: WHO)
Group 1: Kaia COPD software application for self-management of pulmonary rehabilitation, on 3-7 days per week
Group 2: Active control group: physical activity, a brochure ?Besser leben mit COPD?, including written behavioural and exercise recommendations
Criteri per la partecipazione alla sperimentazione
(Fonte di dati: BASEC)
Sie können an der Studie teilnehmen, wenn Sie mindestens 40 Jahre alt sind und einer COPD leiden.
1. Gesicherte COPD-Diagnose, definiert als forciertes expiratorisches Volumen in 1s / forcierte Vitalkapazität (FEV1 / FVC) <70% des vorhergesagten Werts, mit oder ohne chronische Symptome (Husten, Auswurf)
2. FEV1 nach Bronchodilatation von >30% des vorhergesagten Werts
3. Punktzahl von > 20 im CAT bei Studieneinschluss, korrespondierend mit einer hohen und sehr hohen Beeinträchtigung
Criteri di esclusione
(Fonte di dati: BASEC)
Nicht teilnehmen können Personen, die eine Smartphone-Applikation nicht nutzen können oder
1. Der Patient kann aus körperlichen, kognitiven oder aus Sicherheitsgründen das Trainingsprogramm aus sicht des Prüfers nicht durchführen, z.B. nach Gelenkoperationen der unteren Extremität in den letzten 3 Monaten, instabiler Herzerkrankung, vorherrschender neurologischer Einschränkungen, geplanter chirurgischer oder anderweitiger Intervention während der Studie. Dies beinhaltet operative Lungenvolumenreduktion (lung volume reducing surgery, LVRS) oder andere chirurgische oder interventionelle Lungeneingriffe in den letzten 6 Monaten vor Studieneinschluss
2. Langzeit-Sauerstofftherapie (LTOT) mit Flussraten höher als 3l/min oder regelmäßige Benutzung von nichtinvasiver Heimbeatmung (NIV)
3. Erhebliche psychiatrische Erkrankungen, Unmündigkeit oder eingeschränkte Urteilsfähigkeit
Inclusion/Exclusion Criteria
(Fonte di dati: WHO)
Gender: All
Maximum age: None
Minimum age: 40 Years
Inclusion criteria: 1.Male and female patients =40 years of age
2.The patient is willing and able to sign informed consent for use of their pseudonymized clinical data within the scope of the present interventional trial
3.The patient is willing and able to comply with all-study related procedures, including conduction of the video-based 1MSTS in their home environment
4.Diagnosis of COPD, defined as forced expiratory volume in 1s/forced vital capacity (FEV1/FVC) <70% predicted, with or without chronic symptoms (cough, sputum production)
5.FEV1 post Bronchodilator (BD) = 30% predicted
6.CAT score of > 20 at baseline, indicating a high to very high COPD impact level
(after Protocol Amendment 1 DE: 19.01.2023
a) CAT assessment must be taken NOT earlier than 7 calendar days before the screening visit
b) Since CAT assessment:
- There were no changes in patient clinical status
- Patient had no exacerbations
- There were no changes in concomitant medication
c) The CAT assessment was done in writing, is dated and signed and kept as source data at the site.)
7.The patient?s pharmacologic treatment is stable and adherent to recommendations of current GOLD guidelines with no treatment changes in the past 4 weeks, except during a hospitalization with treatment adjustment
8.The patient is motivated to take part in exercise therapy
9.Stable internet access at home to use the application and ability to use the mobile application.
10.Knowledge of German language to understand study material, assessments and contents of the Kaia COPD-App
Exclusion criteria: 1.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, such as LVRS or other surgical or interventional lung procedure in the past six months prior to enrolment
2.Use of Long-term oxygen therapy (LTOT) with flow rates higher than 3l/min or routine use of home non-invasive ventilation (NIV)
3.Significant psychiatric disorders, legal incapacity or limited legal capacity.
4.Participation in another clinical trial with an investigational medication or device within 30 days prior to study entry.
5.Participants already using a COPD self-management application or web-based program
6.Infection with COVID-19 during the trial or in the past six months prior to enrolment or residual symptoms of a COVID infection at baseline (not applicable anymore after Protocol Amendment 1 DE: 19.01.2023)
7.Current or planned participation in inpatient or outpatient pulmonary rehabilitation during the observational period
-
Altre informazioni sulla sperimentazione
Data di registrazione della sperimentazione
26 mag 2021
Inserimento del primo partecipante
26 mag 2021
Stato di reclutamento
Complete
Titolo scientifico
(Fonte di dati: WHO)
The Kaia COPD software Application: a digital therapeutic delivering PR to symptomatic COPD patients for self-management in the home setting ? a randomized, controlled, multicentered and multinational clinical study. - COPD-002 Koala Study
Tipo di sperimentazione
(Fonte di dati: WHO)
interventional
Disegno della sperimentazione
(Fonte di dati: WHO)
Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: parallel; Study design purpose: treatment
Fase
(Fonte di dati: WHO)
N/A
Punti finali primari
(Fonte di dati: WHO)
The two primary endpoints are change in health-related quality of life measured by change in CAT score from baseline and change in physical performance measured by change in number of repetitions of the 1MSTS from baseline after 90 days.
Punti finali secondari
(Fonte di dati: WHO)
All other endpoints are secondary endpoints. These are evaluated at regular intervals during the study and after a follow-up period 180 days after baseline measurement. The secondary endpoints are:
- Health-related quality of life (VR-12)
- Anxiety and depression (HADS)
- Treatment motivation and activation (PAM 13-D)
- Healthcare resource utilization
- Treatment satisfaction and helpfulness
- The adverse events (AEs)
The AE of special interest (AESI): COVID-19
- The device deficiencies
- Change in concomitant medication
- 1MSTS and CAT score changes at the end of the additional follow-up period of 180 days
Exploratory Objectives:
As an exploratory objective, the incidence of mild, moderate or severe exacerbations (GOLD 2022) and the time from inclusion to the first exacerbation were assessed.
As an additional exploratory objective, changes in app usage and associated physical activity were compared between participants that developed COVID-19 during the trial and those that did not.
Contatto per informazioni
(Fonte di dati: WHO)
Kaia Health Software GmbH
Risultati della sperimentazione
(Fonte di dati: WHO)
Sintesi dei risultati
ancora nessuna informazione disponibile
Informazioni sulla disponibilità dei dati dei singoli partecipanti
No
Siti di esecuzione della sperimentazione
Siti di esecuzione in Svizzera
(Fonte di dati: BASEC)
Winterthur, Zurigo
Paesi di esecuzione
(Fonte di dati: WHO)
Germany, Switzerland
Contatto per maggiori informazioni sulla sperimentazione
Dati della persona di contatto in Svizzera
(Fonte di dati: BASEC)
Sabine Schöndorf
+41552566820
sabine.schoendorf@zhreha.ch
Contatto per informazioni generali
(Fonte di dati: WHO)
Rembert
Koczulla
Malterh?h 1
Sch?n-Klinik Berchtesgadener Land
08652 930
rkoczulla@schoen-kliniken.de
Contatto per informazioni scientifiche
(Fonte di dati: WHO)
Rembert
Koczulla
Malterh?h 1
Sch?n-Klinik Berchtesgadener Land
08652 930
rkoczulla@schoen-kliniken.de
Autorizzazione da parte della commissione d’etica (Fonte di dati: BASEC)
Nome della commissione d’etica che rilascia l’autorizzazione (nel caso di studi multicentrici solo la commissione direttiva)
Kantonale
Ethikkommission Zürich
Data di autorizzazione da parte della commissione d’etica
04.05.2021
Altri numeri di identificazione delle sperimentazioni
Numero di identificazione della sperimentazione della commissione d’etica (BASEC-ID)
(Fonte di dati: BASEC)
2021-00691
Secondary ID (Fonte di dati: WHO)
32/21
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