Trial document




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  DRKS00024642

Trial Description

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Title

Coaching and Telemonitoring in Patients with Cystic Fibrosis: ConneCT CF

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Randomized controlled trial to evaluate the efficacy of telemonitoring of adherence, lung function, and health condition in combination with behavior change interventions using innovative digital technologies.

A standard-of-care arm is compared to an arm receiving objective, continuous monitoring of adherence to inhalation therapies, weekly home spirometry using electronic devices with data transmission to patients and caring physicians combined with video conferencing, a self-management app and professional telephone coaching. Duration of the intervention phase is 18 months. The primary endpoint is time to the first protocol-defined pulmonary exacerbation. Secondary outcome measures include number of and time between pulmonary exacerbations, adherence to inhalation therapy, changes in forced expiratory volume in 1 second (FEV1) from baseline, number of hospital admissions, and changes in health-related quality of life. CF-associated medical treatment and care, as well as health care related costs will be assessed by explorative analysis in both arms.

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Brief Summary in Scientific Language

This is a randomized controlled, multi-center, non-blinded trial in patients with CF. First patient inclusion is planned in March 2021. Patients will be randomized 1:1 to the intervention and control group and stratified by age, sex, CFTR modulator therapy and lung function at baseline. A standard-of-care arm (control group) is compared to an intervention arm using the following technologies: objective, continuous monitoring of adherence to inhalation therapies, weekly home spirometry using electronic devices with data transmission to patients and caring CF physicians combined with a self-management app, video conferencing and professional telephone coaching. In standard-of-care, scheduled visits with the caring CF physician take place once quarterly. Further visits only occur at patient's request in cases where the patient's health status deteriorates. In order to evaluate the study interventions in different medical settings, participants will be recruited at CF Centers at four sites: (i) two major cities (Charité - Universitätsmedizin Berlin; Cystic Fibrosis Center Munich-West (ii) one conurbation (University Medicine Essen); and (iii) one rural area (University Medicine Rostock and three associated doctor's practices).
Anthropometric and sociodemographic data, information on clinical history, lung function, pulmonary exacerbations (number and time between exacerbations) and CF-associated admissions to hospital, number of days absent from work or school and CF-associated medical treatment and care are collected at pre-determined time points during the study period. Quality of life will be assessed by the German CF-questionnaire revised and the EQ-5D-5L, screening for depression by the Beck Depression Inventar.
The primary endpoint is the time to first protocol-defined pulmonary exacerbation. Secondary outcome measures include the number of pulmonary exacerbations, time between pulmonary exacerbations, adherence to inhalation therapy, changes of FEV1 and forced vital capacity (FVC) from baseline, number of CF-associated hospital admissions, and changes in health-related quality of life. Furthermore, sociodemographic and anthropometric data, number of days absent from work or school, and CF associated medical treatment and care are assessed by explorative analysis and health care related costs for both study groups are evaluated.
All data will be analyzed between IG and CG (cross-sectional analysis) as well as longitudinally. For the descriptive data analysis adequate measures of location and dispersion will be determined and a correlation analysis will be performed. This will be followed by an inferential data analysis. Depending on the kind of data and data distribution appropriate statistical tests will be applied.
In order to investigate the relationships between the variables, a multivariate analysis and a regression analysis will be performed.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00024642
  •   2021/03/01
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  •   yes
  •   Approved
  •   EA2/241/20, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   E84.0 -  Cystic fibrosis with pulmonary manifestations
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Interventions/Observational Groups

  •   Telemonitoring and Coaching
    Patients with CF in the intervention arm receive objective, continuous monitoring of adherence to inhalation therapies, weekly home spirometry using electronic devices with data transmission to patients and caring physicians combined with video conferencing, a self-management app and professional telephone coaching. Duration of the intervention phase is 18 months, coaching will take place for the first 12 months of the intervention.
  •   Control group
    CG receives a telemedicine capable nebulizer. Data on adherence will be automatically tracked for final evaluation but without any data access for participants or caring CF physicians in this group. Besides, patients of the CG receive standard of care.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Parallel
  •   N/A
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Primary Outcome

time to first protocol-defined pulmonary exacerbation after initiation of the intervention phase

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Secondary Outcome

number of pulmonary exacerbations, time between pulmonary exacerbations, adherence to inhalation therapy, changes of FEV1 and forced vital capacity (FVC) from baseline, number of CF-associated hospital admissions, and changes in health-related quality of life (assessed by CFQR German version and EQ-5D-5L/EQ-5D-Y-5L), non-somatic depression symptoms (Beck Depression Inventar- Fast Screen), sociodemographic and anthropometric data, number of days absent from work or school, and CF associated medical treatment and care, health care related costs

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Planned
  •   2021/03/01
  •   402
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   12   Years
  •   no maximum age
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Additional Inclusion Criteria

confirmed diagnosis of CF, be age 12 years or older and be able to give informed consent or assent, at least one pulmonary exacerbation in the year prior to enrollment, a lung function with a forced expiratory volume in one second (FEV1) < 90% of the predicted value at the day of inclusion and if receiving a CFTR modulator therapy, stable on this treatment for the last three preceding months with no planned change in CFTR modulator treatment during the study period

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Exclusion Criteria

acute depressive or psychotic episode, substantial immobility, no prescribed inhalation therapy, insufficient knowledge of the German language, lack of possession of a smartphone, being post lung-transplantation, not being able to perform lung function testing, or lung function testing being contradicted

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Addresses

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    • Charité Campus Virchow-Klinikum
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Klinik für Pädiatrie m.S. Pneumologie, Immunologie mit Intensivmedizin, Charité – Universitätsmedizin Berlin
    • Mr.  Prof. Dr.  Marcus  Mall 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Klinik für Pädiatrie m.S. Pneumologie, Immunologie mit Intensivmedizin, Charité – Universitätsmedizin Berlin
    • Ms.  Dr.  Stephanie  Thee 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Gemeinsamer Bundesausschuss
    • Gutenbergstraße 13
    • 10587  Berlin
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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